SilverEye Certifications

At Silvereye Certifications, we simplify compliance and certification processes, guiding you to achieve and maintain required industry approvals with complete trust.

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FSSAI License for Ayurvedic and Herbal Food Products: Registration Process Explained

What is FSSAI Registration of Ayurvedic and Herbal Foods?

FSSAI registration of Ayurvedic and herbal foods is a government authorisation provided by the Food Safety and Standards Authority of India that authorises a business to produce, pack, distribute or sell herbal teas, Ayurvedic proprietary foods, herbal dietary supplements, and plant-based nutraceuticals for human consumption. It verifies that your food, its ingredients and production processes comply with India's food safety regulations.

Ayurvedic and Herbal food products are governed by the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, which govern the regulation of such foods by FSSAI. An AYUSH manufacturing license is a separate license requirement for a product being marketed as Ayurvedic medicine with healing properties.

Which License Should You Go For: FSSAI Registration or Ayush Manufacturing License?

Choose correctly at the very beginning of the process and avoid having to change midway through:

Apply for FSSAI registration if the herbal or Ayurvedic formulation is labelled as a food/beverage/tea/nutraceutical and does not have any claims of treating, curing, or preventing a disease.

Apply for an AYUSH manufacturing license if the formulation is being branded as Ayurvedic medicine and has medicinal claims, since it will come under the purview of the Drugs & Cosmetics Act, 1940 and not FSSAI.

Sometimes, both of them may be required: one for the medicinal SKU and the other for the food category SKU. 

Why Should You Register Your Herbal Foods in FSSAI?

Legality: Without proper certification, it is illegal to sell herbal/Ayurvedic food and may result in imprisonment of up to ₹5 lakh under the FSS Act of 2006.

Market entry: Most of the online shopping sites like Amazon, Flipkart, Swiggy Instamart, and even other fast commerce websites check your FSSAI number.

Consumer satisfaction: An official logo and 14-digit registration number tell consumers that your ingredients, hygiene, and labelling have been certified by the FSSAI.

Exporting facility: A central FSSAI license is required to export and supply ayurvedic/herbal food to government departments. 

Types of FSSAI License Based on Business Size

Basic Registration – Applicable for businesses with an annual turnover of up to ₹12 lakh; suitable for small herbal food makers, home-based producers, and petty manufacturers.

State License – Applicable for businesses with an annual turnover between ₹12 lakh and ₹20 crore; suitable for medium-scale Ayurvedic/herbal food manufacturers and traders operating within a single state.

Central License – Applicable for businesses with an annual turnover above ₹20 crore or those involved in import/export activities; suitable for large manufacturers, importers, exporters, and multi-state operators.

Note: Turnover thresholds and category definitions are periodically revised by FSSAI notifications. Always confirm the current limit for your business type on the official FoSCoS portal before applying.

Documents Required for FSSAI License

Form A or Form B (as Applicable) – Basic application and declaration form for the selected FSSAI license type.

Identity & Address Proof of the Applicant – Confirms the legal identity and address of the business owner.

Business Constitution Certificate – Proprietorship proof, partnership deed, or company incorporation certificate establishing the business entity.

List of Herbal/Ayurvedic Ingredients & Sourcing Details – Confirms that all ingredients are permitted for use in food products.

Food Safety Management Plan (FSMS) – Mandatory for Central License applicants.

No Objection Certificate (NOC) from the Local Municipal Authority – Confirms that the business premises comply with local regulations.

Layout Plan of the Manufacturing/Processing Unit – Required for State License and Central License applications.

Product Label Draft – Used to verify compliance with FSSAI labeling requirements before approval.

Process for FSSAI Registration Step by Step

Step 1: Complete your registration on FoSCoS portal (foscos.fssai.gov.in) using mobile and email OTP registration.

Step 2: Choose the right Kind of Business (KoB) – for example, “Manufacturer – Health Supplement/Nutraceutical” for the majority of herbal food products.

Step 3: Complete Form A (Basic) or Form B (State/Central) with required details of business, commodity, ingredients, etc.

Step 4: Provide the necessary documents and pay your government’s charges according to the chosen duration.

Step 5: FSSAI allocates a Unique Application Reference Number; the Food Safety Officer visits the manufacturing units for checking in State/Central cases.

Step 6: After your application is approved, you receive a 14-digit FSSAI license number and Format C certificate, which you need to display at your shop as well as print on your packaging. 

FSSAI License Fees for Ayurvedic and Herbal Food Businesses

Basic Registration – Government fee of ₹100 per year.

State License – Government fee ranges from ₹2,000 to ₹5,000 per year, depending on the nature of the business activity.

Central License – Government fee of ₹7,500 per year.

Applicants can choose a validity period of 1 to 5 years at the time of application, with the fee scaled accordingly. Confirm the exact, current fee slab for your specific business category on the FoSCoS portal, as amounts are revised periodically.

Timeline, Validity, and Renewal

Basic Registration: usually approved within 7–15 working days.

State and Central License: typically 30–60 days for review, and up to 60–90 days overall including inspection.

Validity: chosen at the time of application, from 1 to 5 years (subject to the 2026 perpetual-license reforms for eligible new applicants).

Renewal: apply at least 30–60 days before expiry on FoSCoS; a lapsed license can suspend your right to trade and may attract penalties.

Annual return: manufacturers and importers must file Form D1 by 31 May every year, regardless of license validity period.

conclusion 

While the process of FSSAI registration for Ayurvedic and herbal food products may seem difficult with so many forms, ingredient lists, and turnover slabs, if you know your license type and the necessary documents, it becomes quite simple. The main issues arise only in the form of minor mistakes — such as selecting the right type of Business, or having an incomplete FSMS plan- which can lead to a lengthy process. In this situation, Silveryeye Certifications proves to be a great assistant. 

Our team takes care of everything from determining whether one needs a Basic, State, or Central License, to filling out Form B and gathering the required ingredient lists and the rest of the documents needed for FoSCoS. So whether you are a small herbal tea manufacturer who has just started your home business or a nutraceutical exporter needing help with your Central License application, Silveryeye Certifications is here to file all the necessary documents, making FSSAI registration for herbal food products as easy and quick as possible. 

Contact us on: [phone], and email us at [email protected] 

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FSSAI License for Wholesalers and Distributors: Complete Guide (2026)

Every wholesaler and distributor handling food products in India must hold FSSAI registration or a license before starting operations.

The license type is based on the annual turnover of the company – Basic Registration (less than ₹1.5 Cr), State License (₹1.5 Cr - ₹50 Cr) or Central License (more than ₹50 Cr). 

Government fees are between ₹100 and ₹7,500 annually, and the FoSCoS approval generally takes 7 to 60 days.

FSSAI license is valid for 1 to 5 years and is needed to be renewed 30 days prior to its expiry in order to avoid daily penalties of ₹100

FSSAI license for wholesalers and distributors is a compulsory food safety certificate that is provided by the Food Safety and Standards Authority of India under Section 31 of the FSS Act, 2006. Every wholesaler or distributor of food products, irrespective of its size, should either have Basic Registration, State License or Central License depending upon its turnover. According to the latest turnover slabs from 1 April 2026, enterprises having turnover up to ₹1.5 crore are eligible for Basic Registration (₹100 per year), while those having turnover between ₹1.5 crore and ₹50 crore need a State License (₹5,000 per year) and those having more than ₹50 crore need a Central License (₹7,500 per year).

What Is an FSSAI License for Wholesalers and Distributors?

An FSSAI license for wholesalers and distributors is a certificate required by an FBO before the procurement and distribution of food in bulk quantities. According to FSSAI, the term wholesale refers to any situation where the procurement of food takes place in bulk quantity, which is then sold to resellers or retailers but not directly to consumers. Meanwhile, the term distribution involves the transfer of food from the manufacturer to the person who will finally supply the item to consumers. In either case, both trade/retail and wholesale activities are covered by FoSCoS KoB category, and no exemption applies due to the business size, as both require a license or registration.

FSSAI License Fees for Wholesalers and Distributors (2026)

As per the FoSCoS Kind of Business Eligibility document (updated 1 April 2026), the FSSAI license fee for wholesaler and distributor businesses is fixed purely by annual turnover:

FSSAI License Requirements for Wholesalers

Basic Registration

Annual Turnover: Up to ₹1.5 crore

Suitable for: Small wholesalers

Government Fee: ₹100 per year

State License

Annual Turnover: ₹1.5 crore to ₹50 crore

Suitable for: Medium-sized wholesalers

Government Fee: ₹5,000 per year

Central License

Annual Turnover: Above ₹50 crore

Suitable for: Large wholesalers

Government Fee: ₹7,500 per year

FSSAI License Requirements for Distributors

Basic Registration

Annual Turnover: Up to ₹1.5 crore

Suitable for: Small distributors

Government Fee: ₹100 per year

State License

Annual Turnover: ₹1.5 crore to ₹50 crore

Suitable for: Medium-sized distributors

Government Fee: ₹5,000 per year

Central License

Annual Turnover: Above ₹50 crore

Suitable for: Large distributors

Government Fee: ₹7,500 per year

These are annual government fees. If you opt for a multi-year license (up to 5 years), the fee is multiplied by the number of years chosen at the time of application.

FSSAI Registration License Required Documents

For Basic Registration:

Passport-size photograph along with government ID proof (Aadhaar/ PAN/ Voter ID) of proprietor/ partner

Address proof (electricity bill/rent agreement/property proof)

Basic declaration regarding the food items categories handled 

For State or Central License (higher turnover wholesalers/distributors):

Business constitution document – Partnership Deed, Certificate of Incorporation, or LLP Agreement

Premises evidence – Rent agreement or NOC from owner along with latest utility bill (address should be identical as it is now cross-verified by FoSCoS)

Plan for layout of storage or warehouse premises

Products and category of foods to be distributed or stored

Food safety management system plan or self-declaration

Import/export code, if required as per your business (import/export of food products)

NOC from local municipal/panchayat body, if required 

Step-by-Step Process to Apply for An FSSAI License Online

The entire application for an FSSAI license for wholesalers and distributors is filed online through the FoSCoS portal — the earlier FLRS system has been discontinued.

Step 1:The first step is to open foscos.fssai.gov.in and create the FBO account.

Step 2:Process the type of business by indicating the “Wholesaler” or “Distributor” category.

Step 3:Then select the appropriate license type depending on your annual business turnover.

Step 4:In the next step, fill in Form A (Registration) or Form B (State /central) with the details for your business and your premises.

Step 5: Next, choose the required documents and submit them in a proper format and size.

Step 6:The next step is to pay the due government fee online.

Step 7: The last but one step comes when the authorities consider your application, which may include premises inspection for State/Central license applicants.

Step 8: Once approved, the FSSAI license or registration certificate with the 14-digit license number is issued electronically.

Approval timelines generally range from 7 days (Basic Registration/Tatkal-eligible cases) to about 60 days for State or Central License applications requiring inspection.

Validity and Renewal Timeline

FSSAI license for wholesalers and distributors may be issued for a term of 1 to 5 years as selected by the applicant at the time of application, and the fee shall be paid accordingly for the same. 

Apply for renewal at least 30 days prior to the expiry of the license period

Late renewal, beyond the expiry of the license period, will attract a penalty of ₹100 per day

Failure to renew on time will result in the license expiring; a fresh license is needed — no further food business operations can be carried out

Change in business structure, change in address and changes in products will have to be done via a modification form on the FoSCoS portal 

Benefits of an FSSAI License for Wholesalers and Distributors

Provides legal right to purchase, stock, and distribute food items without any fear of penalty or confiscation

Helps build trust among retailers, brands, and institutions that need an FSSAI license number for signing up

Becomes mandatory while listing on B2B websites and while supplying to organised retail, e-commerce, and modern trade outlets

Enhances visibility and accountability within the distribution chain

FSSAI license number of 14 digits can be printed on the invoice and also helps in verifying for GST purposes 

Conclusion

Getting an FSSAI license isn't just paperwork — it's what lets a wholesaler or distributor legally move food products through the supply chain without risking fines, seizures, or a shutdown. The rules can feel confusing at first (which turnover slab applies, which documents you actually need, how long approval takes), but once you match your business to the right category, the FoSCoS process itself is fairly straightforward.

If you'd rather not deal with the back-and-forth of document corrections, inspection scheduling, or FoSCoS portal errors, Silvereye Certification can handle the entire FSSAI license and registration process for wholesalers and distributors end-to-end — from document checks to final approval — so you can focus on running your business instead of chasing paperwork.

Contact us on: [phone], and email us at [email protected] 

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CDSCO Registration for Face Shields: Complete Class A Medical Device Licensing Guide (2026)

Face shields fall under the category of Class A (low-risk) medical devices according to India’s Medical Devices Rules, 2017.

Exemption from licensing but mandatory online registration through the SUGAM portal.

Average processing time of 2-4 months, validity usually 5 years.

Unauthorised sale of face shields without a CDSCO license may result in their seizure and other consequences. 

A face shield is a Class A (low-risk, non-sterile, non-measuring) device under the Medical Devices Rules, 2017 of India. This means that there will be no need for a manufacturing license; however, registration is mandatory under Chapter IIIB using the CDSCO SUGAM portal (sugam.gov.in). The registration process would involve submission of the Device Master File, Plant Master File, ISO 13485 certificate, product labelling, and the relevant government fees. CDSCO registration for Class A devices takes 2 to 4 months. Importers follow an MD-14 route, and distributors must have an additional state wholesale license. 

What Is CDSCO Registration for Face Shields?

CDSCO registration for face shields is the mandatory registration process under the Central Drugs Standard Control Organisation that allows a firm to manufacture, import or sell face shields as medical devices in India. Since a face shield is an item that protects the eyes and face, it is covered under the Medical Devices Rules (MDR), 2017 and not any other type of product.

Why Face Shield is a Class A Medical Device?

CDSCO categorises all medical devices based on four classes of risk: A, B, C, and D, where A represents the lowest risk category. Face shields fall into Class A since they are non-invasive, do not have any body contact and offer the least possible risk to the user, as they just act as a shield for the eyes and face. The other examples of Class A PPE are particulate respirators and radiation protection caps.

According to MDR 2017, Class A medical devices, which are non-sterile and non-measuring – such as face shields – are exempted from the requirement of licensing under chapters IV, V, VII, VIII, and XI. This implies that no separate license for manufacturing or import of such a device is required, but CDSCO registration online under Chapter IIIB is mandatory.

Benefits of Completing CDSCO Registration for Face Shields

Market accessibility through legality: registration of face shields ensures ease in marketing and distribution of face shields and also exporting them.

Quicker time than Class B, C, or D devices for registration because complete licensing and testing are not needed.

Gain credibility among buyers from hospitals, distributors, and government bids requiring CDSCO-registered PPE.

Less risk of seizure or prosecution in terms of penalties from the Drugs and Cosmetics Act, 1940.

Creation of quality history (DMF, PMF, ISO 13485)

Who Needs CDSCO Registration for Face Shields? (Eligibility)

Registration of face shields is required for all the actors in the supply chain, although the method and type vary based on the actor:

Indian manufacturers making face shields for domestic sale or export purposes.

Importers importing face shields from an international manufacturer.

International manufacturers who have to appoint an Authorised Agent in India for making SUGAM registration on their behalf.

Hospitals or institutions manufacturing face shields for their use.

Distributors, wholesalers, and retailers are not involved in the registration of the product as it is the responsibility of the manufacturer or the importer, while they need a medical device wholesale license issued by their State Licensing Authority for selling the registered product.

Step-by-Step CDSCO Registration Process for Face Shields

Validate device classification to be CDSCO Class A, non-sterile, non-measuring notification for Face Shields.

Prepare company profile, and log into SUGAM portal (sugam.gov.in) – application is purely online only.

Prepare the technical file – this involves DMF, PMF, ISO 13485 certificate, labelling and undertaking of compliance.

Fill the relevant online form; for manufacturers, this will be the Chapter IIIB registration route, whereas for importers, this would be Form MD-14.

Pay the relevant government fee via SUGAM payment gateway and save the receipt.

Submit application; CDSCO shall provide file/reference number to track application progress.

Quickly reply to any deficiency communications from the CDSCO reviewers.

Download your registration certificate ( or MD-15 for import license) via the SUGAM portal post-approval.

Maintain records of batches, supplies, and complaints for a minimum of 5 years for post-market compliance.

CDSCO Registration Fees for Face Shields

Face shields are also categorised under Registration, hence bear the lowest fee among the other 3 categories. The official CDSCO Fees are mentioned in the Second Schedule of the MDR and are liable to change periodically. It's best practice to cross-check the prevailing fee with the fee schedule on the SUGAM portal before proceeding with the registration. Other expenses that companies usually bear include dossier fees, cost of ISO13485 certification (if already obtained) and fees for consulting services(optional). 

Validity and Renewal of CDSCO Face Shield Registration

Registrations and licenses granted under the MDR 2017 have a validity of up to 5 years from the date on which it is issued. To retain its validity, the company must re-apply before the expiry date with revised technical and quality documents. It's recommended to file the application a few months before expiry to secure continuity of your registration. The prescribed term is listed on the certificate of the registration/license. 

Conclusion

Classification of a face shield under CDSCO is definitely not the daunting process of acquiring approvals under classes C and D; however, even for a class A device, the classification "low risk" does not imply "zero documentation". You will still need to have a Device Master File, a Plant Master File, ISO 13485 certification, and no violations in the SUGAM portal to be able to produce, import or market your device. Failing to do so will lead to your perfectly developed and compliant device being seized and penalised.

Those organisations who manage to get through all this without any issues are typically those which approach it as an organisational task, rather than a guessing game – having the classification clarified upfront and reacting promptly to any queries by CDSCO. Doing so will allow you to deal with a relatively easy approval such as this. 

Contact us on: [phone], and email us at [email protected] 

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Cosmetic Loan Licence Registration in India: Process, Fees & Documents (2026)

Cosmetic loan licensing enables different manufacturers to produce cosmetics in another company’s GMP-certified factory.

You need to file Form COS-6 with the State Licensing Authority (SLA) to obtain a loan license and, if granted, the SLA issues a license in Form COS-9.

SLA must approve or reject a loan license application within 45 days of submission of a complete application.

The cosmetic loan license is valid forever after issuance, as long as the retention fee is paid every five years. 

Cosmetic loan licence registration is the legal process that allows a brand or company without its own factory to manufacture cosmetics using a third-party, GMP-compliant, licensed manufacturing facility in India. The applicant files Form COS-6 with the State Licensing Authority (SLA) through the online portal, along with a self-declaration (Form COS-7), the manufacturing agreement with the licensed facility owner, and the prescribed fee. 

What Is a Cosmetic Loan Licence?

A cosmetic loan licence is a manufacturing permission issued under the Cosmetics Rules, 2020 (framed under the Drugs and Cosmetics Act, 1940) to a person or company that wants to manufacture cosmetics for sale but does not own a factory. Instead, the applicant "borrows" — hence "loan" — the manufacturing premises, plant, and equipment of another manufacturer who already holds a valid cosmetic manufacturing licence (Form COS-8). 

This is one of the most common routes used by new cosmetic and personal-care brands, private-label sellers, and D2C companies to enter the Indian market quickly, since building a GMP-compliant factory from scratch is capital-intensive and time-consuming.

Benefits of a Cosmetic Loan Licence

Lower initial investment – no need to build or purchase your own manufacturing facility.

Reduced lead times for launching new cosmetic brands and products.

Full legal right to manufacture, brand and sell cosmetics under your own company name.

Ability to add or change manufacturing partners as your product line grows.

Eligibility Criteria for Cosmetic Loan Licence Registration

Once issued, the licence is valid forever provided that a retention fee is paid every five years.

The applicant should be a legally constituted entity, i.e. proprietorship, partnership, LLP or company registered in India.

The applicant is not required to own a manufacturing plant, but must have a signed manufacturing/loan agreement with a plant that has a valid Form COS-8 licence.

The third-party premises shall conform to Good Manufacturing Practices (GMP) and the requirements of the Seventh Schedule. 

The cosmetic products to be manufactured must fall within the recognised product categories under the Fourth Schedule of the Cosmetics Rules, 2020. 

Cosmetic Loan License Registration Steps

Establish a tie-up arrangement with a GMP-approved manufacturer possessing a valid Form COS-8 cosmetic manufacturing license. 

Draft an agreement for manufacturing/loan specifying details relating to the responsibilities, products, and usage of premises.

Fill up Form COS-7 Declaration with all other requisite forms. 

Submit Form COS-6 online on the portal of the State Licensing Authority (SLA) linked with the SUGAM website.

Pay the fee specified in the Third Schedule of the Cosmetics Rules, 2020. 

Address deficiency memos/query issued by SLA while scrutinising the application. 

Inspection of manufacturing premises to check the accuracy of the COS-7 Declaration and documentation.

If found satisfactory, SLA issues loan license in Form COS-9 in 45 days’ time from date of application.

Get the loan license number printed on the labels of all products.

Make payment of retention fee once every five years to ensure perpetuity of license.   

Cosmetic Loan Licence Fees

Grant of Loan Licence (up to 10 items per category): ₹10,000 per category, as prescribed in the Third Schedule.

Additional Items (beyond 10 in the same category): ₹500 per additional item.

Licence Retention Fee (every 5 years): Payable as specified in the Third Schedule before the completion of every five-year licence period.

Late Retention Fee (within the 180-day grace period): 2% of the applicable retention fee for each month or part of a month of delay.

Validity, Renewal & Retention of the Loan Licence

As per the provisions of Rule 30 of the Cosmetics Rules, 2020, the cosmetic loan license granted on Form COS-9 is valid indefinitely and does not require renewal in the conventional manner. Rather, the holder shall pay the license retention fee prior to completion of five years from the date of grant of the license, and thereafter, every five years thereafter.

In case the license retention fee is not made, a grace period of 180 days exists for payment of the license retention fee along with a late fee of 2% per month. In case the license retention fee is not paid even after 180 days, then the license will be cancelled, and the applicant will have to start from scratch.  

Cosmetic Loan Licence vs Cosmetic Manufacturing Licence

Ownership of Premises:

Loan Licence (COS-6 / COS-9): The applicant is not required to own a manufacturing facility and uses a third-party manufacturer's premises.

Manufacturing Licence (COS-5 / COS-8): The applicant owns or leases the manufacturing unit.

Application Form:

Loan Licence: Form COS-6.

Manufacturing Licence: Form COS-5.

Licence Granted In:

Loan Licence: Form COS-9.

Manufacturing Licence: Form COS-8.

Ideal For:

Loan Licence: Startups, D2C brands, and private-label cosmetic sellers.

Manufacturing Licence: Established cosmetic manufacturers with their own production facility.

Validity:

Loan Licence: Perpetual, subject to payment of the retention fee every five years.

Manufacturing Licence: Perpetual, subject to payment of the retention fee every five years.

Conclusion

Obtaining a cosmetic loan license does not necessarily mean spending months of frustration and struggling with the process. Regardless of whether you are a start-up, D2C, or private label, using the process of obtaining the license for a loan through Form COS-6, it will be possible for you to manufacture cosmetics without having to build a factory and incur the expenses. It is at this point that Silveryeye Certifications comes in — we can guide you through the whole process of registering your cosmetic loan license, from identifying a manufacturer who is GMP certified and holds a COS-8 license, filling the necessary COS-7 self-declaration, filing the application, and following up to ensure that you receive your Form COS-9 license. We will even remind you of the deadline for paying the five-year retention fee. If you are ready to enter the cosmetic industry, contact Silveryeye Certifications now.

Contact us on: [phone], and email us at [email protected] 

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CDSCO Registration for Disposable Syringes: Class B Compliance Guide 2026)

Disposable syringes are basically treated as Class B  low-to-moderate risk type medical devices under CDSCO’s MDR 2017 setup, so it is not in the higher risk buckets; it’s more like medium level oversight. 

For Indian manufacturers, the process is self-certification under Rule 19, using Form MD-5, then the State Licensing Authority issues the manufacturing license via Form MD-9. 

For foreign manufacturers who want to sell into India, they generally need an Import License like MD-14 or MD-15, but it’s filed through an Indian Authorised Agent, not directly. 

The Class B license is usually valid for 5 years, and it should be renewed using an updated risk-classification check before it expires; otherwise the whole thing lapses.

So How Do You Register Disposable Syringes with CDSCO?

Since disposable syringes come under CDSCO Class B, the CDSCO Registration for Disposable Syringes ends up following the self-certification route under Rule 19 of the Medical Device Rules (MDR) 2017, even though people sometimes expect “full registration” in every case. Indian manufacturers typically file Form MD-5 on the SUGAM portal, along with a Declaration of Conformity, ISO 13485 certificate, a device master file, plus a risk management report, and then the State Licensing Authority (SLA) issues the manufacturing license on Form MD-9, often in a window of 60–120 days, depending on review backlogs. 

What Does CDSCO Class B Classification Mean for Disposable Syringes?

CDSCO, the Central Drugs Standard Control Organisation under the Ministry of Health and Family Welfare, places every medical device that’s sold in India into four risk categories, A, B, C and D, like it’s all under the Medical Device Rules, 2017. Disposable hypodermic syringes fall into Class B together with things such as nebulisers, surgical instruments and blood-glucose monitors. These are devices that have a modest but genuine potential to influence patient well-being if something goes wrong, so they require extra paperwork and supervision compared to Class A products, for example gloves or bandages, but they’re still not in the same audit-heavy zone as Class C/D items like ventilators or implants. 

Who Needs CDSCO Registration for Disposable Syringes?

In general, any company that manufactures, imports, sells, or distributes disposable syringes in India should have valid CDSCO Class B compliance before the product actually reaches the market. This covers, 

Domestic manufacturers producing syringes at an Indian site 

Foreign manufacturers exporting syringes into India through a distributor or subsidiary, even if the brand is well known 

Importers and authorised agents filing applications on behalf of an overseas principal 

Loan-license manufacturers using a third-party manufacturing facility; sometimes the arrangement feels slightly indirect, but the obligation remains 

Eligibility Criteria for Class B Syringe Registration

Before applying, a manufacturer should confirm the following baseline requirements are in place, since the SLA checks each one during scrutiny:

Registered manufacturing premises with adequate infrastructure and trained technical staff

A valid ISO 13485 Quality Management System certificate covering syringe production

A documented risk management file aligned with ISO 14971

A Device Master File and Plant Master File specific to the syringe product line

Registration of the business entity and manufacturing site on the CDSCO SUGAM portal 

Documents Required for CDSCO Disposable Syringe Registration

Before applying, a manufacturer should kind of confirm that these baseline requirements are already in place, because the SLA checks each item during scrutiny, not later: 

Registered manufacturing premises with enough infrastructure and trained technical staff 

A valid ISO 13485 Quality Management System certificate that actually covers syringe production 

A documented risk management file aligned with ISO 14971, and yes, it should be ready before anything else 

A Device Master File plus a Plant Master File specific to the syringe product line 

Registration of the business entity and manufacturing site on the CDSCO SUGAM portal 

Step-by-Step CDSCO Registration Process for Disposable Syringes (2026)

First, confirm the classification against the CLA list: CDSCO's October 2025 directive says that for every Class B applicant, you have to check the device classification versus the Central Licensing Authority's official, live-updated list before you actually file. If the disposable syringes are already in Class B, then this is mostly a confirmation, but if a particular syringe variant isn’t there, you need to ask the CLA for classification first, kind of like a pre-filing step. 

Next, register on the SUGAM portal: Set up an organisation profile on the CDSCO's online SUGAM portal, which is the mandatory entry gate for all Class A to D applications. Also add the manufacturing location details, plant address, and related particulars there.

Prepare the Declaration of Conformity and technical file: Bring together the Device Master File, the Plant Master File, the ISO 13485 certificate, plus the risk management paperwork. After that, sign the Declaration of Conformity under Rule 19, basically confirming the syringe aligns with the essential safety and performance principles.

Then, File Form MD-5 and pay the fees: Submit the online application along with every attachment, and pay the required government fee using the portal's challan system. It should match exactly what the portal expects; otherwise, you may get delays.

Handle SLA queries or possible inspection: The State Licensing Authority can send clarification requests or do a sampling-type facility audit. Usually, Class A/B products get a bit lighter, risk-based review compared with Class C and D, which can involve more full audits.

Finally, receive the manufacturing license (Form MD-9): Once things are found satisfactory, the SLA issues the manufacturing licence via Form MD-9. This is generally valid for five years, counted from the date it is issued. 

Renewal Process for the CDSCO Class B License

The Class B manufacturing license for disposable syringes has to be renewed before the 5-year validity runs out. In practice, renewal means you redo a few checks, like re-verifying the present risk classification using the CLA’s latest list, making sure your ISO 13485 certificate is still active, paying the required retention/renewal fee, and then submitting the renewal request on the SUGAM portal before the expiry date. If someone lets the license lapse, it is not really a “renewal” anymore; they have to submit it again as a brand-new application, because that kind of restart brings back the review timeline from the beginning. 

Conclusion:

CDSCO registration for disposable syringes does not have to feel complicated once you see how it fits in the system: Class B, handled via self-certification under Rule 19, submitted through Form MD-5, and finally issued on Form MD-9 by your State Licensing Authority. The tricky part is the preparation, though—having a clean ISO 13485 certificate, a complete Device Master File, and an up-to-date risk management report will carry you through that 60–120-day window quicker than repeating follow-up calls to the SLA again and again. Do the classification check early, keep everything audit-ready, and note your renewal timing the day the license is actually granted, so the 5-year validity never surprises you. Whether you are a domestic manufacturer filing your first MD-5, or a foreign brand working through an Indian Authorised Agent for the import license route, the quickest way to move forward is basically the same: confirm the classification correctly, build documentation thoroughly, and file in one go, right.

Contact us on: [phone], and email us at [email protected] 

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FSSAI Registration for Ayurvedic and Herbal Food Products: Complete 2026 Guide

What is FSSAI Registration of Ayurvedic and Herbal Foods?

FSSAI registration of Ayurvedic and herbal foods is a government authorisation provided by the Food Safety and Standards Authority of India that authorises a business to produce, pack, distribute or sell herbal teas, Ayurvedic proprietary foods, herbal dietary supplements, and plant-based nutraceuticals for human consumption. It verifies that your food, its ingredients and production processes comply with India's food safety regulations.

Ayurvedic and Herbal food products are governed by the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, which govern the regulation of such foods by FSSAI. An AYUSH manufacturing license is a separate license requirement for a product being marketed as Ayurvedic medicine with healing properties.

Which License Should You Go For: FSSAI Registration or Ayush Manufacturing License?

Choose correctly at the very beginning of the process and avoid having to change midway through:

Apply for FSSAI registration if the herbal or Ayurvedic formulation is labelled as a food/beverage/tea/nutraceutical and does not have any claims of treating, curing, or preventing a disease.

Apply for an AYUSH manufacturing license if the formulation is being branded as Ayurvedic medicine and has medicinal claims, since it will come under the purview of the Drugs & Cosmetics Act, 1940 and not FSSAI.

Sometimes, both of them may be required: one for the medicinal SKU and the other for the food category SKU. 

Why Should You Register Your Herbal Foods in FSSAI?

Legality: Without proper certification, it is illegal to sell herbal/Ayurvedic food and may result in imprisonment of up to ₹5 lakh under the FSS Act of 2006.

Market entry: Most of the online shopping sites like Amazon, Flipkart, Swiggy Instamart, and even other fast commerce websites check your FSSAI number.

Consumer satisfaction: An official logo and 14-digit registration number tell consumers that your ingredients, hygiene, and labelling have been certified by the FSSAI.

Exporting facility: A central FSSAI license is required to export and supply ayurvedic/herbal food to government departments. 

Eligibility, License Categories, and Fees

FSSAI classifies every food business — including Ayurvedic and herbal food manufacturers, marketers, and re-labellers — into one of three categories based on annual turnover and business activity:

Basic Registration

Who it's for: Small herbal food sellers, home-based Ayurvedic tea/spice brands, and petty manufacturers

Annual turnover: Up to ₹1.5 crore

Government fee: ₹100 per year

State License

Who it's for: Mid-size herbal/Ayurvedic food manufacturers, marketers, storage units, and single-state distributors

Annual turnover: ₹1.5 crore to ₹50 crore

Government fee: ₹5,000 per year

Central License

Who it's for: Large manufacturers, importers/exporters, and multi-state or e-commerce herbal food brands

Annual turnover: Above ₹50 crore, or businesses involved in import/export or multi-state operations regardless of turnover

Government fee: ₹7,500 per year

Documents Required for Ayurvedic and Herbal Food FSSAI Registration

Photograph and identity proof of the proprietor/partners/directors in passport size

Document of proof of the premises where the business is running (rent deed or letter from the owner, or property document)

Certificate of incorporation, partnership deed or LLP agreement

Products list with their complete formulation details

FSMS Plan and Form IX with the name of the food safety supervisor

For manufacturers: Plant/layout plan, Machinery details and Water Test Report

NOC from the municipal corporation and Declaration regarding the source and quality of herbal raw material, in case of State/Central License

Manufacturing agreement in case of contracted manufactured brand

Process for FSSAI Registration Step by Step

Step 1: Complete your registration on FoSCoS portal (foscos.fssai.gov.in) using mobile and email OTP registration.

Step 2: Choose the right Kind of Business (KoB) – for example, “Manufacturer – Health Supplement/Nutraceutical” for the majority of herbal food products.

Step 3: Complete Form A (Basic) or Form B (State/Central) with required details of business, commodity, ingredients, etc.

Step 4: Provide the necessary documents and pay your government’s charges according to the chosen duration.

Step 5: FSSAI allocates a Unique Application Reference Number; the Food Safety Officer visits the manufacturing units for checking in State/Central cases.

Step 6: After your application is approved, you receive a 14-digit FSSAI license number and Format C certificate, which you need to display at your shop as well as print on your packaging. 

Timeline, Validity, and Renewal

Basic Registration: usually approved within 7–15 working days.

State and Central License: typically 30–60 days for review, and up to 60–90 days overall, including inspection.

Validity: chosen at the time of application, from 1 to 5 years (subject to the 2026 perpetual-license reforms for eligible new applicants).

Renewal: apply at least 30–60 days before expiry on FoSCoS; a lapsed license can suspend your right to trade and may attract penalties.

Annual return: manufacturers and importers must file Form D1 by 31 May every year, regardless of the license validity period.

Frequently Asked Questions

Is FSSAI registration mandatory for herbal and Ayurvedic food items?Yes. All businesses that manufacture, package, distribute, or sell herbal food products, herbal teas, or Ayurvedic nutraceuticals intended for consumption must obtain an FSSAI registration or license, irrespective of their business size.

What is the difference between an FSSAI registration and an AYUSH license for herbal products?FSSAI registration is required for herbal products marketed as food or nutraceuticals without medicinal claims. An AYUSH license is required only for products classified as Ayurvedic medicines that make therapeutic or medicinal claims.

Which FSSAI license is required for a home-based herbal food business?A home-based business selling herbal food products such as herbal tea, spice mixes, or pickles with an annual turnover of up to ₹12 lakh generally requires Basic FSSAI Registration, which costs ₹100 per year.

What documents are required for an FSSAI license for herbal food products?The required documents typically include:

Identity proof of the applicant

Address proof

Business registration proof

List of products and ingredients

Food Safety Management System (FSMS) plan

Manufacturing unit layout (for manufacturers)

Water testing report (for manufacturers)

How long does it take to obtain an FSSAI registration for Ayurvedic food products?

Basic Registration: 7–15 days

State License: 30–90 days

Central License: 30–90 days, depending on document verification and premises inspection.

Can herbal or Ayurvedic food products be sold on e-commerce or quick-commerce platforms without FSSAI registration?No. E-commerce and quick-commerce platforms require a valid FSSAI registration or license number before listing any food, herbal, or nutraceutical products.

What are the penalties for selling herbal food products without FSSAI registration?Selling food products without the required FSSAI registration is a violation of the Food Safety and Standards Act, 2006, and may attract penalties of up to ₹5 lakh and/or imprisonment for up to six months, depending on the nature of the offence.

Is a Central FSSAI License mandatory for exporting Ayurvedic and herbal food products?Yes. Businesses engaged in the import or export of herbal and Ayurvedic food products are required to obtain an FSSAI Central License.

What is the cost of an FSSAI registration or license for an Ayurvedic food business?

Basic Registration: ₹100 per year

State License: ₹2,000–₹5,000 per year (depending on business category)

Central License: ₹7,500 per year (payable for 1–5 years in advance)

How can an FSSAI license be renewed?Apply for renewal through the FoSCoS portal at least 30–60 days before the license expiry date, along with the applicable renewal fee, to avoid suspension or cancellation.

Are herbal ingredients permitted in FSSAI-licensed food products?Yes. Herbal ingredients are permitted only if they comply with the FSSAI Nutraceutical and Health Supplements Regulations, 2016, and meet all applicable safety and labelling requirements.

conclusion 

While the process of FSSAI registration for Ayurvedic and herbal food products may seem difficult with so many forms, ingredient lists, and turnover slabs, if you know your license type and the necessary documents, it becomes quite simple. The main issues arise only in the form of minor mistakes — such as selecting the right type of Business, or having an incomplete FSMS plan will lead to a lengthy process. In this situation, Silveryeye Certifications proves to be a great assistant. 

Our team takes care of everything from determining whether one needs a Basic, State, or Central License, to filling out Form B and gathering the required ingredient lists and the rest of the documents needed for FoSCoS. So whether you are a small herbal tea manufacturer who has just started your home business or a nutraceutical exporter needing help with your Central License application, Silveryeye Certifications is here to file all the necessary documents, making FSSAI registration for herbal food products as easy and quick as possible. 

Contact us on: [phone], and email us at [email protected] 

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BIS CRS Approval for Scanners in India: Complete 2026 Guide

Scanners come under the category of IT equipment according to BIS CRS and are tested to IS 13252 (Part 1) or IS/IEC 62368-1.

Manufacturers can apply for the license only; foreign manufacturers require an Authorised Indian Representative.

Approval takes 4-8 weeks, including lab testing, application through the BIS CRS online portal, and the BIS evaluation.

The certificate is valid for 2 years and needs renewal at least 90 days prior to expiry. 

BIS CRS approval for scanners is mandatory registration of products by the Bureau of Indian Standards under the Compulsory Registration Scheme that must be obtained before any type of scanner – flatbed, sheet-fed, handheld, barcode, or document – can be made or imported into India. It certifies the compliance of a product with the safety requirements established in IS 13252 (Part 1) and its modern equivalent, IS/IEC 62368-1. The process includes lab testing, online BIS CRS application, document submission, and BIS evaluation. Manufacturers can obtain the license only; foreign manufacturers need an Authorised Indian Representative. 

What Does BIS CRS Registration for Scanners Entail?

BIS CRS is a safety certificate granted by the Bureau of Indian Standards(BIS) as per the BIS Act, 2016. The scheme is applicable to all notified information technology and electronics goods. The scheme ensures that the scanner does not pose a danger of electric shock, fire hazard, or mechanical injury and enables those products that clear the scheme's criteria to display the BIS standard mark together with a registration (R) number on the product and packaging. 

Why BIS CRS Certification For Scanners Is Compulsory?

Manufacture, import, and sale of a notified scanner in India without valid BIS CRS registration is a criminal act as per the BIS Act, 2016 and may lead to the seizure of goods, penalty, or prosecution. Besides legal compliance, the scheme will also:

Avoid customs clearance delays of imported scanner consignments

Build consumer and market confidence – mandatory for listing on Amazon, Flipkart, and other e-commerce sites

Establish compliance with electrical safety and EMC requirements 

Who Requires BIS CRS Certificate for Scanners? (Eligibility)

Manufacturers of scanners in India

Exporters of scanners from abroad to India through Authorised Indian Representative (AIR)

OEMs / Brand Owners selling scanners with their own brand name

Note: Only the manufacturer gets the BIS CRS certificate and not the importer/trader/distributor. The importer must ensure that their vendor holds a valid BIS CRS certificate for that specific scanner before placing the order. 

Standard for Scanner in India

Scanners are tested against IS 13252 (Part 1), titled “Information technology equipment - safety - general requirements,” or IS/IEC 62368-1, applicable now to safety of audio-video and ICT equipment. Testing as per the standard includes:

Electrical safety – insulation, dielectric strength, proper wiring

Resistance to fire hazards

Mechanical safety

Electromagnetic compatibility (EMC) 

Documents Required for BIS CRS Registration

Keep these ready before you start the application — missing documents are the single biggest cause of delay:

Documents Required for BIS CRS Registration for Scanners

Company Incorporation Certificate / Factory Registration Certificate

Proves the legal identity of the manufacturer.

Authorised Indian Representative (AIR) Authorisation Letter

Mandatory for foreign manufacturers applying for BIS CRS registration.

Test Report from a BIS-Recognized Laboratory

Confirms that the scanner complies with IS 13252 (Part 1) or IS/IEC 62368-1 (as applicable).

Technical Documents

Includes product schematics, circuit diagrams, specifications, and user manual.

Used to verify the product's design and safety features.

Trademark / Brand Registration Proof

Establishes ownership of the brand under which the scanner is being registered.

Affidavit-cum-Undertaking (Format C)

A self-declaration confirming that the product complies with BIS CRS requirements.

Manufacturing Address Proof

Confirms the official manufacturing facility address mentioned in the BIS application.

Step-by-Step BIS CRS Registration Process for Scanners

Identify the appropriate standard – Either IS 13252 (Part 1) or IS/IEC 62368-1.

Appoint an Authorised Indian Representative (only applicable to foreign manufacturers).

Conduct the testing of the scanner in a BIS-recognized lab; test reports are valid up to 90 days. 

Submit the application using the BIS CRS portal with test reports and other documents.

BIS examines the application and raises any question that requires clarification.

Clarify the raised question by BIS. 

BIS issues the CRS registration certificate with an R-number.

Affix the BIS Standard Mark and registration number on the product/package.

BIS CRS Registration Fees for Scanners

The application fee and an annual maintenance fee have to be paid along with lab testing charges, which vary with the type of scanner and scope of the test. The fee structure varies for Indian and foreign manufacturers, with the foreign manufacturers having to pay a higher fee. Since BIS changes the fees from time to time, you must verify the fee structure from the official BIS CRS website at the time of application.

Validity and Renewal of the BIS CRS Certificate

The initial certificate of registration shall be valid for 2 years from the date of issuance.

Renewal of the certificate can be obtained for 2, 3, and 5 years.

The renewal should be filed 90 days prior to the expiry of the validity period.

Product testing is not needed for renewal unless there is a change in design or standard.

Missing out on the renewal will lead to expiration of the license.

Conculsion

BIS CRS certification requirements for scanners can be quite overwhelming, from the documentation process to the timeline of lab tests and questions that arise when using the online portal. This becomes even more complicated when you consider the need to understand the Authorised Indian Representative requirement for foreign manufacturers for the first time. In reality, the whole process can actually be broken down into simple eligibility criteria, documentation, testing, and renewal process. This is where the services of Silveryeye Certifications become helpful to you. Starting from helping you determine which standard to adhere to (IS 13252 Part 1 or IS/IEC 62368-1), through coordination of lab test process, documentation preparation, becoming your Authorized Indian Representative (for foreign manufacturers), and managing the timeline for your renewal prior to the expiration of the 90 days, Silveryeye Certifications takes care of all BIS CRS registration processes regarding scanners so that you are assured of meeting all deadlines or getting a rejected application.

Contact us on: [phone], and email us at [email protected] 

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SIMS Registration: Complete Guide to the Steel Import Monitoring System Certificate in India (2026)

SIMS registration is compulsory to import steel products falling in HS Chapters 72, 73, and 86.

The fixed government charges are ₹500 per application, and the obtained certificate will be valid for 75 days.

One needs to submit an application on the DGFT SIMS portal with his IEC verified by either Aadhaar OTP or DSC.

For small MSME importers, there is an alternative of SARAL SIMS for one-time annual registration.

The SIMS Registration is a compulsory online registration that every importer has to do prior to the importation of notified iron and steel products in India. The products covered in this procedure include iron and steel products under Chapters 72, 73, and 86 of the ITC (HS) Code. The application is submitted on the DGFT portal with the IEC number of the importer. The importer pays a fixed government fee of ₹500 and gets a URN, which remains valid for 75 days.

What Is SIMS Registration?

SIMS Registration means online registration through the Steel Import Monitoring System. The Steel Import Monitoring System (SIMS) is an online portal provided by the Directorate General of Foreign Trade (DGFT). Under the DGFT, which operates under the Ministry of Commerce & Industry of India, before any notified steel goods enter India, SIMS registration should be done to obtain a Unique Registration Number (URN) that needs to be provided to Customs while submitting the Bill of Entry.

The SIMS portal receives advance information of the shipment regarding the exporter, manufacturer, country of origin, specification, quantity, and value. All this information is received and released weekly through the website of the Ministry of Steel.

The Ministry of Steel upgraded SIMS to SIMS 2.0 in July 2024 by linking it with the portal of DGFT. The new version of SIMS reduces the number of fields in the application form from 56 to 20 along with compulsory Aadhaar-based OTP or DSC authentication facility, thus reducing the time required for SIMS registration.

Why Was the Steel Import Monitoring System Launched?

The launch of SIMS registration by the government was mainly intended to stop the dumping of cheap or inferior quality steel in the Indian market. The registration system will enable DGFT and the Ministry of Steel to have information about the import volumes and initiate anti-dumping or safeguard measures in case there is any kind of competition against the domestic industry.

Who Needs SIMS Registration in India?

Any person or firm that imports steel products with respect to the notified HS codes, irrespective of the size of the consignment, will need to get SIMS registration. They include:

Actual Users – Manufacturers who use steel as their raw material in their factory

Importers of steel products for trading or selling

Importers’ Agents or Customs House Agents (CHA)

Traders & Brokers dealing with notified steel products

Advance Authorisation Holders who import steel materials for exports

Which Steel Products Require SIMS Registration?

SIMS registration is mandatory for products falling under Chapters 72, 73, and 86 of the ITC (HS), 2022 Schedule-1 classification. As of the 2026 update, this covers several hundred tariff lines at the 8-digit HS code level.

Chapter 72 – Iron and Steel (Primary Products)

ITC (HS) Chapter: 72

Product Category: Iron and Steel (Primary Products)

Typical Examples: Flat-rolled products, bars, rods, wire, coils, billets

Chapter 73 – Articles of Iron or Steel

ITC (HS) Chapter: 73

Product Category: Articles of Iron or Steel

Typical Examples: Pipes, tubes, structures, fasteners, fittings

Chapter 86 – Railway/Tramway Steel Items

ITC (HS) Chapter: 86

Product Category: Railway/Tramway Steel Items

Typical Examples: Rails, sleepers, and track fixtures

SIMS Registration Eligibility Criteria

To be eligible for completing SIMS registration, you need to fulfil the below conditions:

You should have a valid Importer-Exporter Code (IEC) from DGFT

You must be a registered user on the DGFT website connected to your IEC

Your DSC or your mobile number /email ID linked to your Aadhaar card for OTP must be available

The product that you are importing must be under one of the notified HS codes (72, 73 or 86)

SIMS registration must be completed before filing your Bill of Entry with customs

Documents Required for SIMS Registration

The below documents and information should be available to you before applying for your SIMS registration.

A valid certificate of IEC

DSC or Aadhaar OTP linked to DGFT account

Purchase order or commercial invoice for your steel consignment

Details of the exporter & manufacturer along with their addresses and contacts

Details regarding the country of origin of your steel product

Technical specifications of the product along with its applicable Indian standard (IS), if any

Appropriate 8-digit HS code classification of the imported product

Step-by-Step SIMS Registration Process on the DGFT Portal

The following is the procedure for SIMS registration at the DGFT portal:

Go to the DGFT portal (dgft.gov.in), login with your IEC account credentials.

Use the Aadhaar-based OTP or Digital Signature Certificate (DSC) for authentication.

Choose the Import Management System tab, and click on SIMS.

Click on Start Fresh Application and add the exporter's name, manufacturer’s name, and the country of origin of the product.

Add product-specific details like HS Code, technical details, quantity, and CIF value of each product. You can add multiple products within one single application.

Mention whether a similar grade of steel is produced in India along with reasons for the import.

Make payment of the government fee and click on Final Submit. No modification will be allowed after submission.

Generate the acknowledgement slip and remember the URN (Unique Registration Number) automatically generated by the portal.

Benefits of Completing SIMS Registration

Custom clearance process is streamlined and not delayed for the notified steel consignment. No chances of your consignment getting delayed or rejected at the port of destination. Complete compliance with the provisions of the Foreign Trade (Development and Regulation) Act, 1992 and the Customs Act, 1962 facilitates a transparent and evidence-based trade policy for the Indian steel industry. Compliance history for future import permissions.

conclusion 

Registration with SIMS is an inevitable compliance process for any importer planning to bring steel products to India by 2026. With a simple registration cost of INR 500, a 75-day validity period and the new SARAL SIMS registration facility for smaller importers, the process has gotten easier than its predecessors; however, attention to detail is important, as you won’t be able to edit your application once you submit it. SIMS registration is the most convenient way to ensure unhindered customs clearance of your steel consignments.

Contact us on: [phone], and email us at [email protected] 

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CDSCO Registration for Contact Lenses (Class B): Complete Guide to MD-3/MD-5, MD-14/MD-15 & MD-41

Contact lenses are classified under Class B (Low-Moderate Risk) medical device category according to the Indian Medical Devices Rules, 2017.

Indigenous manufacturers register by filing Form MD-3 and get the manufacturing license on Form MD-5 from their State Licensing Authority.

Importers file Form MD-14 and receive the import license on Form MD-15 that remains in force till the time it is suspended, revoked, or surrendered.

Distributors, wholesalers, and retail opticians trading contact lenses require filing of Form MD-41 application and receipt of Form MD-42 registration certificate. 

The contact lens requires compulsory CDSCO registration as it comes under Class B Ophthalmic Medical Device according to the Medical Devices Rules, 2017. Indigenous manufacturers get a Form MD-5 manufacturing license by filing the Form MD-3 with their State Licensing Authority. The companies that are importing the contact lenses from abroad file the Form MD-14 and get the Form MD-15 import license from the CDSCO Central Licensing Authority. Distributors, wholesalers, and retail opticians should file the Form MD-41 application and get the Form MD-42 registration certificate. Each application is registered on the Sugam portal and needs ISO 13485 certification as well as a Device Master File. 

What Is CDSCO and Why Does It Regulate Contact Lenses?

The Central Drugs Standard Control Organisation (CDSCO), working under the Directorate General of Health Services, Ministry of Health & Family Welfare, acts as the country's drug licensing and controlling authority. As per the Medical Devices Rules, 2017 (MDR 2017), each medical device, including ophthalmic devices such as contact lenses, sold, manufactured, distributed, or imported into India, requires a valid CDSCO license or registration.

Since contact lenses come into direct contact with the cornea for an extended period, they pose more risks compared to a passive device such as spectacle frames. This is the reason CDSCO registration for contact lenses is required to confirm that the material used is safe, has oxygen permeability, is sterile, and that the manufacturing process is sound. 

CDSCO Forms Explained: MD-3/MD-5 vs MD-14/MD-15 vs MD-41/MD-42

The specific form you file depends entirely on your business activity, not just your device class. Here is how the three CDSCO pathways for a Class B contact lens business compare:

Here is the information converted into clear bullet points:

Manufacturing in India

Application Form: MD-3

License Issued: MD-5

Issuing Authority: State Licensing Authority (SLA)

Importing into India

Application Form: MD-14

License Issued: MD-15

Issuing Authority: Central Licensing Authority (CDSCO)

Wholesale, Distribution, or Retail Sale

Application Form: MD-41

License Issued: MD-42

Issuing Authority: State Licensing Authority (SLA)

MD-3/MD-5 covers Indian manufacturers of Class A and B ophthalmic devices. MD-14/MD-15 applies to any business bringing contact lenses into India from a foreign manufacturer, regardless of device class. MD-41/MD-42 covers the commercial stocking, distribution, and sale layer — opticians, wholesalers, and e-commerce sellers of contact lenses all need this.

Who Needs Which CDSCO License for Contact Lenses?

Domestic manufacturer of contact lenses – requires MD-3/MD-5 from State Licensing Authority.

Foreign brand of contact lenses making its way to India – requires appointment of an Indian Authorised Agent possessing MD-42 wholesale licence that applies for MD-14/MD-15 on its behalf.

Importer/distributor of ready-made contact lenses into India – requires MD-14/MD-15.

Optical retail store/hospital pharmacy/online seller – requires MD-41/MD-42 to keep and sell contact lenses.

Often, multiple licences can be required simultaneously – for instance, importers with their own retail shops usually possess MD-15 as well as MD-42. 

Many businesses need more than one license at once — for example, an importer who also runs its own retail stores typically holds both MD-15 and MD-42.

Eligibility Criteria for CDSCO Registration

A registered legal business entity in India (or, for foreign manufacturers, an Indian Authorised Agent with a valid wholesale license).

A Quality Management System compliant with ISO 13485:2016.

Manufacturing premises meeting MDR 2017 Schedule V requirements (for manufacturing license applicants).

Qualified technical staff — typically a pharmacist or a person with a relevant science/engineering qualification and device-handling experience.

A complete Device Master File and Plant Master File describing the contact lens material, water content, packaging, and intended use.

Documents Required for Contact Lens CDSCO Registration

An Indian company registered under law (or an Indian Authorised Agent for foreign manufacturers having a valid wholesale license).

A Quality Management System which meets the ISO 13485:2016 standard.

Premises in accordance with the MDR 2017 Schedule V conditions (for applications for manufacture license).

Skilled technical manpower – generally a pharmacist or someone with scientific/technological qualification and experience with the device.

A detailed Device Master File and Plant Master File specifying details about the contact lens material, moisture level, packaging and intended use of the contact lens. 

Step-by-Step CDSCO Registration Process for Contact Lenses

Duly completed form MD-3, MD-14, and MD-41.

ISO 13485:2016 certificate for the quality management system.

Device Master File (DMF), which includes material composition, water content, base curve and diameter range, labelling and purpose.

Plant Master File (PMF) and plant layout plan (for manufacturers).

Upload all supporting documents and pay the applicable fee through the Bharatkosh payment gateway.

Test reports for performance and biocompatibility.

Power of attorney to grant authorisation to Indian Agent (foreign companies).

Copy of MD-42 wholesale license held by the authorised agent.

Compliance declaration of MDR 2017 for storage and handling — applicable even for solutions. 

CDSCO Fees for Contact Lens Registration

Here is the information converted into clear bullet points:

MD-5 (Manufacturing License – Class B)

Typical Fee: Approx. ₹5,000 per manufacturing site + ₹500 per distinct product

Note: Fee is paid to the State Licensing Authority (SLA) and may vary slightly from state to state.

MD-15 (Import License)

Typical Fee: Approx. USD 1,000 per manufacturing site/product (basic fee)

Note: The fee increases with additional manufacturing sites or product models.

MD-42 (Wholesale/Distribution License)

Typical Fee: Nominal, state-specific fee

Note: The fee is determined by the respective State Licensing Authority (SLA).

Processing Timeline

Manufacturing License under MD-5: typically about 3-4 months, mainly depending upon the speed with which the site inspection is scheduled and done.

Import License under MD-15: typically takes 8-9 months after filing, as per industry timelines because of central-level document scrutiny and query process.

Wholesale/Registration Certificate under MD-42: typically the quickest of the three, normally sorted within a few weeks after sorting out the document.

Correct and complete documentation during the first attempt is the most important point that will help avoid any delay. 

Conclusion

The registration of contact lenses with CDSCO is not just a single form process – it all depends on whether you manufacture, import, or distribute. Manufacturers go through the MD-3/MD-5 route, importers through the MD-14/MD-15 route, and wholesalers or retailers go through the MD-41/MD-42 route. Obtaining the correct classification, documentation, and ISO 13485 certification right from the beginning is the key to keeping the process moving smoothly and complying with India’s Medical Devices Rules, 2017.

 Contact us on: [phone], and email us at [email protected] 

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Guide to BIS CRS Certification for Video Monitors in India – How to Get

BIS CRS is mandatory for all video monitors sold/imported/manufactured in India.

Governing Standard: IS/IEC 62368-1:2023 (Superseding IS 616:2017)

The certificate is valid for 2 years and needs to be renewed with fresh test reports.

Foreign manufacturers shall appoint an Authorised Indian Representative (AIR) for the purpose of filing.

BIS CRS registration for video monitors (registered under the Bureau of Indian Standards’ Compulsory Registration Scheme) is mandatory certification under India’s Compulsory Registration Scheme. Imported brands need to be tested at a BIS-recognised lab under IS/IEC 62368-1:2023 and apply on the BIS CRS portal by the manufacturers or their Authorised Indian Representative. BIS then issues a Certificate of Registration with a unique R-Number, which is valid for two years. Without this registration, it is illegal to sell or import a video monitor in India.

What Is BIS CRS Registration for Video Monitors?

It affirms that a video monitor model is compliant with India’s safety standard IS/IEC 62368-1:2023, superseding IS 616:2017. It covers LED, LCD and CCTV display monitors and is given model-wise and not brand-wise. 

Who Needs It? (Eligibility)

Indian manufacturers of video monitors.

Foreign manufacturers exporting to India, through an Authorised Indian Representative.

Importers and brand owners selling video monitors under their own brand name.

Documents Required

GST certificate and certificate of company incorporation.

Test report from a BIS-approved lab.

Technical data sheet and user’s manual. 

AIR authorisation letter for foreign manufacturers.

Product label and marking layout.

How to Register

Identify the standard IS/IEC 62368-1:2023 applicable.

Send the sample to a BIS-recognized lab for testing.

Fill out the online application form through the BIS CRS website.

Address any queries from BIS while the documents are being reviewed.

Obtain the Certificate of Registration and R-Number. 

Fees

The fee consists of a one-time application fee, lab testing fees and an annual fee based on production or import volume. Costs vary by lab and model complexity, so get a lab quote early. 

Validity, Renewal and Timeline

Valid for Two Years (renew before expiry with new test reports if the standard has changed). Registration generally takes three to six months. 

Benefits

Legal access to the Indian market.

Faster customs clearance for imports.

Higher buyer and consumer trust.

Eligibility to list on major online marketplaces. 

Conclusion

BIS CRS registration for video monitors is not optional paperwork — it is the legal gateway to sell, import, or manufacture video monitors in India. Manufacturers and importers that get ahead of the game avoid the lab capacity crunch that is expected as the November 2028 transition deadline approaches. With the shift to IS/IEC 62368-1:2023 now underway, the first steps are to: 1. Get your documents in order; 2. Choose a BIS-recognised lab 3. Appoint an Authorised Indian Representative (if you’re a foreign manufacturer). Done right, BIS CRS registration protects your business from penalties and customs delays and builds the consumer trust that gets your video monitors on Indian shelves and marketplaces faster. 

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BIS CRS Registration for Tablets in India: Complete Guide to Compulsory Certification (2026)

Tablet BIS CRS registration in India is necessary since the tablet belongs to “automatic data processing equipment” – a category notified by the Ministry of Electronics & Information Technology (MeitY) within the scope of the BIS CRS scheme. It can only be done by the actual manufacturer of the product, either domestic or foreign, with an Authorised Indian Representative (AIR). The process includes lab testing in BIS-accredited labs, online application on the BIS CRS portal, and self-declaration of conformity. After successful registration, the tablet will be eligible to bear the BIS Standard Mark with an individual R-number. Initially, it is valid for two years. 

What Is BIS CRS Registration for Tablets?

Compulsory Registration Scheme (CRS) is a process carried out by the Bureau of Indian Standards (BIS) according to a MeitY notification, which helps ensure that the products of electronic and IT goods sold in India meet certain safety standards and quality parameters before they are delivered to customers. Tablets are included in the scheme since they are classified as “automated data processing equipment” along with laptops and computers. In CRS, a manufacturer sends his product for testing in an authorised BIS laboratory, issues a self-declaration of conformity, and gets a registration number, which must be indicated on the product and on its packing as the BIS Standard Mark. In contrast with ISI marking, CRS registration does not include obligatory plant inspection.

Who Needs BIS CRS Registration for Tablets?

Manufacturers of tablets based in India that manufacture tablets locally for distribution in India

Foreign manufacturers exporting tablets to India with the help of an Authorised Indian Representative (AIR)

Original Equipment Manufacturers (OEMs) and brands purchasing finished tablets from the manufacturer and selling them as their brand with the approval of the manufacturer

Importers and traders cannot apply directly since BIS issues this license only to the manufacturer. Therefore, importers need to ensure that the tablets being imported have a valid BIS CRS certification issued to the manufacturer. 

Eligibility Criteria

Applicant must be the manufacturer of the tablet and not a reseller or retailer

Separate registration is required for each manufacturing facility, regardless of the identical nature of the product

The model of the tablet should be among the products covered under the BIS CRS list and conform to Indian Standards (IS)

Foreign manufacturers should appoint an AIR based in India

Documents Required for BIS CRS Registration

Test Report from a BIS-Recognized Laboratory

Confirms that the tablet complies with the applicable Indian Standard.

The test report is generally valid for 90 days from the date of issue.

Company / Manufacturing Unit Details

Legal business registration documents.

Proof of the manufacturing facility address.

Trademark / Brand Registration Certificate

Establishes ownership of the registered brand or trademark used on the tablet.

Product Technical Documents

Printed Circuit Board (PCB) layout.

Product user manual.

List of critical components and specifications.

KYC Documents of the Manufacturer and Authorised Indian Representative (AIR)

Identity proof and address proof of the manufacturer.

Authorisation documents for the AIR (mandatory for foreign manufacturers).

Self-Declaration of Conformity

A signed declaration by the manufacturer confirming that the tablet complies with the applicable BIS/IS requirements.

BIS CRS Registration Process for Tablets (Step-by-Step)

Determine the Indian Standard applicable to your tablet

Determine which Indian Standard specification is applicable to your tablet by referring to the CRS-notified product list.

Product testing

Send your samples to a laboratory authorised by BIS for conducting tests. The test report is valid for 90 days only.

Registration on the BIS CRS portal

Sign up on the official website of BIS CRS and register yourself along with the manufacturer, product information, and AIR (Applicant Identification Record) for a foreign manufacturer.

Application submission with required documents

Attach the test report, technical document, trademark evidence, and self-declaration of conformity to the application.

BIS CRS application evaluation

BIS authorities will evaluate the test report and documentation and will also verify your compliance with the Indian Standard specified. Any queries raised must be answered within 30 days at most.

Issue of CRS Registration Certificate

After evaluation and clearance, BIS will issue the CRS registration certificate with an R-number, after which the BIS Standard mark can be put on your tablet packaging.

Processing Timeline

Indian (Domestic) Manufacturer: Typical processing time is 20–30 working days.

Foreign Manufacturer (via Authorised Indian Representative – AIR): Typical processing time is 60–90 working days.

Delays commonly occur due to incomplete documentation, failed sample tests, or additional BIS clarifications — preparing paperwork in advance helps avoid these.

Validity and Renewal

The first registration of BIS CRS is valid for a period of 2 years from the date of issuance.

Renewal can increase validity by a period of 1 to 5 years depending on the requirements of the applicant and approval by BIS.

File for the renovation way before expiry (many consultants advise doing so at least 90 days prior) using the required documents and a new test report.

If you fail to renew the certificate on time, your registration will expire, and the BIS Standard Mark will no longer be applicable. 

Benefits of BIS CRS Registration for Tablets

Market entry legitimacy – the product cannot be manufactured, imported or sold without BIS CRS certification.

Simplifies customs process.

Increases customer trust due to third-party guarantee of safety (BIS Standard Mark).

Avoids listing rejection on marketplaces that ask for BIS proof. 

Conclusion

BIS CRS registration of tablets is not a mere formality; it is the legal procedure through which a tablet becomes legally allowed to be manufactured, imported, or marketed in India. To do it right is to identify the Indian Standard for your product, test it at an approved laboratory within the 90-day period of validity, and file the application for BIS CRS registration via the AIR if required. With this proper planning, manufacturers and brands save themselves from getting stuck in the customs clearance process, market rejections, and fines, and gain consumer trust associated with the BIS Standard Mark. When planning a launch of a new tablet in India, get ready to start BIS CRS registration as soon as possible and always check your application fees and timelines on the official website.

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CDSCO Registration for Surgical Mask (Class A): Import, Wholesale & Manufacturing License Guide 2026

Surgical Masks come under Class A (low-risk) medical devices according to the Medical Devices Rules, 2017.

Manufacturers require Form MD-3 (application) / MD-5 (license); importers require Form MD-14 / MD-15; wholesalers require Form MD-41 / MD-42.

All applications are done online at the CDSCO SUGAM portal, with payment of the application fee done online.

The validity period of the license is five years and needs to be renewed before expiration. 

CDSCO registration for surgical masks (Class A) is the mandatory license issued by India's CDSCO that allows manufacturing, importing and wholesaling of surgical masks. Manufacturers apply on Form MD-3 and obtain Form MD-5; importers apply on Form MD-14 and obtain Form MD-15 (Or an import registration certificate, as the surgical masks are Class A medical devices that are not sterile); wholesalers or distributors apply on Form MD-41 and obtain Form MD-42.

What is CDSCO Registration for a surgical mask?

CDSCO registration for a surgical mask is the clearance obtained in accordance with the Medical Devices Rules, 2017 (MDR 2017) prior to manufacture/import/stocking/sale of the mask in any part of India. CDSCO is an organisation working under the Directorate General of Health Services, Ministry of Health & Family Welfare, which issues the clearance for sale of the mask in India. A surgical mask is considered a medical device used for protection against droplet transmission while in clinical use and therefore cannot be sold in India without having such clearance, irrespective of whether it is locally manufactured or imported from another country. 

Why CDSCO Registration Is Mandatory

Selling a surgical mask without CDSCO clearance violates Drugs and Cosmetics Act and may result in seizure of the product, fines, and shutdown of the business. In addition to being a legal requirement, the clearance is important for gaining customers' trust, bidding on government/hospital tenders, and proving that the product complies with quality and safety standards in India. For the manufacturers and importers, this clearance is practically necessary since most of the hospitals, distributors, and e-commerce platforms will not accept a surgical mask brand without a valid CDSCO license number 

CDSCO License for Surgical Mask by Business Type

The applicable form depends entirely on your business activity — manufacturing, importing, or wholesale distribution. Here is a quick reference:

Manufacturing (Class A)

Application Form: MD-3

Grant Form: MD-5

Licensing Authority: State Licensing Authority (SLA)

Validity: 5 years

Import

Application Form: MD-14

Grant Form: MD-15 (or Import Registration for non-sterile Class A devices)

Licensing Authority: Central Licensing Authority (CDSCO Headquarters)

Validity: No fixed expiry; retention fee applies

Wholesale / Distribution

Application Form: MD-41

Grant Form: MD-42

Licensing Authority: State Licensing Authority (SLA)

Validity: 5 years

Manufacturing License (Form MD-3 / MD-5)

Indian manufacturers of Class A surgical masks apply on Form MD-3 to the State Licensing Authority (SLA) of the state where the manufacturing unit is located. Once the plant details, quality management system, and product documentation are found satisfactory, the SLA grants the manufacturing license on Form MD-5.

Import Registration / License (Form MD-14 / MD-15)

Foreign manufacturers exporting surgical masks to India must appoint an Indian Authorised Agent, who files the application on Form MD-14 with CDSCO headquarters (the Central Licensing Authority). Since surgical masks are typically non-sterile, non-measuring Class A devices, many applicants only need an import registration rather than a full MD-15 license — but this should always be confirmed against your specific product's intended use and sterility claim before filing.

Documents Required

Device Master File (DMF) containing details of design, materials, and intended use.

Plant Master File (PMF) for manufacturers with information on facility layout, equipment, and manufacturing process.

ISO 13485 Quality Management System certificate.

Test reports demonstrating filtration efficiency and safety of the product.

Free Sale Certificate of the country of origin (in case of importing products into India).

Power of Attorney for authorizing the Indian Agent (for non-Indian applicants).

Proof of company incorporation, GST Registration, and identity proof of authorized signatory.

Product labeling and Instructions for Use according to MDR 2017.

Classify the product to verify its status as Class A under MDR 2017.

Step-by-Step CDSCO Registration Process

Register in the CDSCO SUGAM portal as an authorized signatory.

Prepare Device Master File, Plant Master File, test reports, and other documents.

Choose the appropriate form – MD-3, MD-14, or MD-41 depending on the nature of your business.

Submit documents and pay the required fee as per government rules through portal.

Answer any deficiency queries asked by CDSCO/State Licensing Authority.

Go for site inspection if required.  

Validity, Renewal, and Retention

MD-5 and MD-42 licenses generally have a validity of five years from the date of issue. Import approvals generally do not come with an expiry date but have to pay retention fees periodically to maintain the status. Begin the renewal process 90 days prior to expiry to prevent interruption in manufacturing, importation, or sale activities and to update post-marketing surveillance as well as adverse events documentation throughout the term of the license. 

Conclusion

Registration of the surgical mask under CDSCO regulations is a one-time but absolutely essential step for those who manufacture, import, or wholesale surgical masks in India. Due to the fact that this product belongs to Class A devices, the procedure will be easier compared to higher categories; however, the basic principle remains the same – the manufacturer has to fill Form MD-3/MD-5, the importer Form MD-14/MD-15, and wholesaler MD-41/MD-42 forms through the CDSCO SUGAM portal. Making sure you choose the correct classification, documentation, and form is what helps you receive your approval within the fastest possible timeframe, and therefore it is recommended to allow sufficient time for preparation of the Device Master File, Plant Master File, and test reports. 

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BIS CRS Registration for Wireless Keyboards in India (2026): Complete Guide

The wireless keyboards are recognised IT products; thus, the BIS CRS registration process should be undertaken in advance of the sale or distribution of the equipment in India.

The applicable standard has changed from IS 13252 (Part 1):2010 to IS/IEC 62368-1:2023, and they would continue to be valid till the 1 November 2028.

It is important to note that there is no need for a process in the factory — the approval is based fully on the laboratory test results and the self-declaration of conformity.

Normally, the complete registration process takes three to six months to complete, and the license is valid for two to five years 

In India, the Bureau of Indian Standards BIS CRS registration for wireless keyboards is an obligatory certification, as per the rules stated in its Compulsory Registration Scheme. It has to be done before manufacturing, importing, or selling a wireless keyboard. The procedure requires running tests on the keyboards at a laboratory recognised by BIS and submitting the application along with required documents on the BIS CRS (Manak) portal. Upon approval of the application, the applicant will get a unique R-number. Factory inspection is not required, and registration usually takes around 3 to 6 months and is valid for a period of 2 to 5 years, but has to be renewed three months before its expiration.

What Is BIS CRS Registration?

The Compulsory Registration Scheme (CRS) is a regulation enforced jointly by the Bureau of Indian Standards (BIS) and the Ministry of Electronics and Information Technology (MeitY). It mandates that electronic and IT products — including wireless keyboards — meet defined Indian safety and quality standards before entering the Indian market. Once approved, the product carries the BIS Standard Mark with a unique registration number, signalling to consumers, e-commerce platforms, and customs authorities that it is compliant.

Is BIS CRS Registration Mandatory for Wireless Keyboards?

Yes. Wireless keyboards fall under the notified IT equipment category, so any manufacturer, brand owner, or importer must register each model before it is sold, stored for sale, distributed, or imported into India. Selling an unregistered wireless keyboard can lead to shipment holds at customs, marketplace delisting on platforms like Amazon and Flipkart, and financial penalties.

Benefits of BIS CRS Registration

Legal entry into the market - mandatory for manufacturing, importing, or selling in India.

Easier customs clearance and lower chances of shipment delays.

Mandatory to get listed on major e-commerce portals.

Creates customer and retailer trust by way of tested safety compliance testing.

Ensures avoiding penalties, confiscation of products or a ban for non-compliant products.

Who Needs to Apply?

Indian manufacturers should apply via the official BIS CRS portal directly. Foreign manufacturers need to appoint an Authorised Indian Representative (AIR), which means an officially registered legal Indian entity that will handle the application, act as a mediator with BIS, and be responsible for compliance locally. The R-number is obtained in the name of the foreign manufacturer. A new registration is needed for every production unit and, usually, for every product type. 

Documents Required for BIS CRS Registration

Duly filled BIS Application Form – Basic applicant and product identity.

Test Report from BIS-Recognized Laboratory – Proof of conformity with IS/IEC 62368-1:2023.

PCB Layout & Schematic Diagram – Technical verification of the product's circuitry.

User Manual & Critical Component List – Ensures safety compliance and component traceability.

Factory/Applicant Address Proof – Legal verification of the manufacturing unit or applicant's address.

Authorisation Letter (if signed by an authorised representative) – Confirms the signing authority.

AIR (Authorised Indian Representative) Nomination Form (for foreign manufacturers) – Appoints the local representative in India.

Trademark/Brand Ownership Proof – Confirms legal ownership of the brand or trademark.

Step-by-Step BIS CRS Registration Process

Step 1: Make an account and generate login details on the BIS CRS (Manak) portal.

Step 2: Make a test request for the wireless keyboard model and select the BIS-approved lab.

Step 3: Attach the QR Code generated by the system with the sample and dispatch it for testing.

Step 4: Testing the sample in the lab for electrical safety, electromagnetic safety, ergonomics and other general safety parameters.

Step 5: Filing the application form with required documentation and paying the fee.

Step 6: Review of submitted documents and test report by BIS – No factory inspection is carried out.

Step 7: After obtaining the approval, you will receive the R-number and affix the BIS Standard Mark & label to your product. 

BIS CRS Fees for Wireless Keyboards

Fees vary based on applicant turnover, number of models, and the testing lab chosen. Approximate ranges:

Application Fee – ₹1,000 (Domestic) / ₹1,000 + applicable processing charges (Foreign manufacturers); payable through the BIS CRS Portal.

Registration/Annual Fee – ₹5,000–₹10,000 per model, per year; varies based on the applicable turnover slab.

Laboratory Testing Charges – Approximately ₹15,000–₹40,000; depends on the BIS-recognized laboratory and the required testing scope.

Authorised Indian Representative (AIR) Appointment (For Foreign Manufacturers) – One-time legal/consultancy cost; not a BIS fee, but the cost of appointing a local representative in India.

Validity, Renewal & Labelling

The BIS CRS license is normally issued for a definite time period and can be renewed for another 2-5 years period. Application for renewal has to be made at least 3 months before expiry through the BIS CRS portal. Any changes in the manufacturing plant, AIR, or legal entity need to be reported to BIS. The approved product shall bear a permanent marking which is water-resistant and abrasion-resistant and can be in the form of printing, embossing or metal plate. It should include the following information: product name, model number, brand name, manufacturer’s particulars, country of manufacture and the R-number. 

Conclusion

Registration of Wireless Keyboards under BIS CRS is a process that needs to be done only once per model but continuously in terms of compliance. In this way, it helps protect the consumer and manufacturer by being legally compliant in India's electronics market. Given the introduction of the new standard IS/IEC 62368-1:2023, companies should plan accordingly in advance and complete testing and documentation well before the transition deadline of November 2028. This article provides the information based on the CRS guidelines as of 2026.

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CDSCO Medical Device Registration for Surgical Instruments: Class A, B, C & D Guide (2026)

Mostly, surgical instruments are in CDSCO Class A or B based on invasiveness and risk.

Registration is online on the SUGAM portal, with the forms being MD-5 (manufacture) or MD-14/15 (import).

Class A/B instruments usually take 30-120 days for approval, longer for Class C/D.

In India, it is legally mandatory to have a valid CDSCO licence before you manufacture, import or sell notified surgical instruments. 

CDSCO medical device registration for surgical instruments is the compulsory approval process as per the Medical Devices Rules, 2017, that allows manufacturers and importers to market surgical instruments in India legally. Most reusable surgical instruments (scissors, forceps, scalpels) are classified as Class B (low-moderate risk). Simple non-invasive tools may be classified as Class A.Class B applications need an MD-5 manufacturing licence or MD-14/15 import licence, filed via the SUGAM portal with a Device Master File, Plant Master File, and ISO 13485 certificate. Approval usually takes 30-120 days, and the licence stays valid for five years.

What Is CDSCO and Why It Regulates Surgical Instruments

The Central Drugs Standard Control Organisation (CDSCO), under India's Ministry of Health and Family Welfare, regulates all medical devices — including surgical instruments — through the Medical Devices Rules, 2017 (framed under the Drugs and Cosmetics Act, 1940). No notified surgical instrument can be legally manufactured, imported, or sold in India without a valid CDSCO licence. The rules follow a risk-based classification system aligned with the Global Harmonisation Task Force approach used internationally, so India's framework broadly mirrors what manufacturers already follow for EU or US markets.

CDSCO Classification of Surgical Instruments: Class A, B, C & D

Every device is placed into one of four risk classes. Correct classification is the single most important step, since choosing the wrong class is one of the leading causes of application rejection or delay.

Class A (Low Risk)

Risk Level: Low risk

Examples: Elastic bandages, examination gloves, hand-held non-invasive instruments, absorbent cotton

Licensing Authority: State Licensing Authority

License Requirement: Simplified registration

Class B (Low–Moderate Risk)

Risk Level: Low–moderate risk

Examples: Most surgical instruments (scalpels, forceps, scissors), syringes, nebulisers, hypodermic needles

Licensing Authority: State Licensing Authority

License Form: MD-5 (Manufacturing)

Class C (Moderate–High Risk)

Risk Level: Moderate–high risk

Examples: Infusion pumps, X-ray machines, orthopaedic implants, ventilators

Licensing Authority: Central Licensing Authority

License Form: MD-9 (Manufacturing)

Class D (High Risk)

Risk Level: High risk

Examples: Heart valves, pacemakers, drug-eluting stents, artificial joints

Licensing Authority: Central Licensing Authority

License Form: MD-9 (Manufacturing)

Eligibility for CDSCO Surgical Instrument Registration

Indian manufacturers should have a valid manufacturing site, quality management system and technical staff as prescribed.

Foreign manufacturers have to appoint an Indian Authorised Agent or set up an Indian subsidiary to file the import application.

The applicant must demonstrate compliance with the ISO 13485 Quality Management System and risk management as per ISO 14971.

Devices must appear on, or be reasonably comparable to, CDSCO's notified device list.

Documents Required for CDSCO Registration

Device Master File (DMF) — design, intended use, and technical specifications

Plant Master File (PMF) — manufacturing site and process details

ISO 13485 certification

Free Sale Certificate (mandatory for imported devices)

Device test reports and performance/safety data

Labelling and Instructions for Use compliant with CDSCO norms

Risk management report as per ISO 14971

Step-by-Step CDSCO Registration Process

Step 1: Identify the appropriate classification of the equipment (A, B, C or D) according to the CDSCO-approved list. 

Step 2: Collect relevant technical details, including DMF, PMF, ISO13485 certificate and test reports.

Step 3: Create an account and fill in the application on SUGAM portal according to the relevant application form (e.g. MD-5 for manufacturing and MD-14 for import). 

Step 4: Pay the necessary government fees based on the class of the product and type of application made. 

Step 5: To answer any queries raised by CDSCO evaluators during the process. 

Step 6: Get yourself inspected/audited if required (mandatory for classes C & D).

Step 7: Receive your licence (example: MD-9 for manufacture, MD-15 for import).

CDSCO Registration Fees for Surgical Instruments

Fee of registration fee differs based on the type of device being registered, the type of licensing being applied (manufacturing/importing), and how many variations of the product are included in the application. To make sure one has the latest fees for registration, instead of using the old data from the applicable legislation, it should be confirmed with CDSCO/SUGAM, or the fee should be checked with the consultants performing the registration process to date. 

Approval Timeline and Licence Validity

Class A

Typical Approval Timeline: 30–60 days

Licence Validity: 5 years, subject to continued compliance

Class B

Typical Approval Timeline: 60–120 days

Licence Validity: 5 years, subject to continued compliance

Class C

Typical Approval Timeline: 120–240 days (site audit usually required)

Licence Validity: 5 years, subject to continued compliance

Class D

Typical Approval Timeline: 180–365 days (full site audit required)

Licence Validity: 5 years, subject to continued compliance

Timelines can extend if CDSCO raises deficiency queries, so keeping documentation complete and consistent at first submission is the fastest way to avoid delays.

Renewal of CDSCO Licence

License holders must make periodic compliance and retention assessments; therefore, it is essential to remain up to date regarding the quality management system, labelling, and post-market surveillance. Hence, manufacturers need to monitor the five-year validity of the license in order to initiate the renewal process before expiration to avoid missing out on compliance obligations. 

Conclusion

The registration of medical devices done at CDSCO regarding surgical tools protects the welfare of patients and allows manufacturers to gain access to the growing market for medical devices in India. Therefore, getting the classification done correctly, preparing an appropriate technical file, and filing the application through the SUGAM portal on time contribute to a faster issuance of Class A, B, C, or D registration. 

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CDSCO Korean Face Serum Registration: Complete COS-1, COS-2, COS-5 & COS-8 Guide (2026)

Imported Korean face serums need COS-1 (application) followed by COS-2 (Import Registration Certificate), valid for 5 years.

Locally manufactured Korean-formulation serums need COS-5 (application) followed by COS-8 (manufacturing licence), valid indefinitely with a retention fee every 5 years.

CDSCO approval can take up to 180 working days under the Cosmetics Rules, 2020, so timing your launch matters.

Selling or importing an unregistered Korean serum in India can lead to stock seizure and penalties under the Drugs and Cosmetics Act, 1940.

CDSCO Korean face serum registration is the mandatory approval every Korean-made or Korean-formulation face serum needs before it can be legally imported, sold, or manufactured in India, under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. Imported serums go through Form COS-1 (application) to Form COS-2 (Import Registration Certificate, valid for 5 years). Serums manufactured in India go through Form COS-5 (application) to Form COS-8 (manufacturing licence, valid indefinitely with a 5-year retention fee). Registration requires a Free Sale Certificate, ingredient list, compliant labelling, and Power of Attorney, and typically takes several months from a complete filing.

What Is CDSCO Korean Face Serum Registration?

The Central Drugs Standard Control Organisation (CDSCO) is India's central regulator for cosmetics under the Ministry of Health & Family Welfare. Any Korean face serum — whether it is a vitamin C serum, snail mucin serum, or a niacinamide formulation — falls under the legal definition of a "cosmetic" in the Drugs and Cosmetics Act, 1940, and must be registered before it enters the Indian market. This applies whether the serum is imported directly from Korea or manufactured in India under a Korean brand's formulation.

COS-1, COS-2, COS-5 & COS-8: What Each Form Actually Does

These four forms cover two separate regulatory pathways — import and domestic manufacturing — and it's common for first-time importers to confuse them.

COS-1

Purpose: Application for cosmetic import registration

Filed With: CDSCO SUGAM Portal

Route: Import (Foreign-made serum)

Validity: N/A (Application only)

COS-2

Purpose: Import Registration Certificate (Issued after COS-1 approval)

Issued By: Central Licensing Authority

Route: Import

Validity: 5 years from the date of issue

COS-5

Purpose: Application for grant of Manufacturing / Loan Licence

Filed With: State Licensing Authority

Route: Manufactured in India

Validity: N/A (Application only)

COS-8

Purpose: Manufacturing / Loan Licence (Issued after COS-5 approval and inspection)

Issued By: State Licensing Authority

Route: Manufactured in India

Validity: Valid in perpetuity, subject to payment of the retention fee every 5 years.

Import Route: COS-1 → COS-2

This is applied when the face serum is entirely manufactured in Korea and thereafter imported. In this case, an Indian official, agency or importer proceeds to file the Form COS-1 on the CDSCO SUGAM portal. After examination of the formulation, label, and Free Sale Certificate, the CDSCO grants COS-2 registration certificate. 

Domestic Manufacturing Route: COS-5 → COS-8

This route becomes applicable when the serum containing the Korean formulation is manufactured inside India, such as under licensing agreements or through white labelling. Here, the applicant files the Form COS-5 with the State Licensing Authority. The Licensing Authority verifies the application documents and performs the Good Manufacturing Practice check before issuing the COS-8 license. 

Who Needs This Registration?

Korean cosmetic manufacturers and brand owners to export serums to India

Indian importers, distributors, and agents to bring in Korean serums

E-commerce owners and other private labels to buy serums with Korean formulation

Indian contractors to manufacture serums with Korean formulation in India 

Eligibility Requirements

For the import route, the applicant must be either the overseas manufacturer directly, an Indian subsidiary of the manufacturer, or an authorised Indian agent holding a valid Power of Attorney or Authorisation. The manufacturing site in Korea must be identified with its full address, and every serum variant and pack size must be mapped to CDSCO's cosmetic category list. For the domestic manufacturing route, the applicant must have (or be setting up) a manufacturing premise that can meet Schedule M-II Good Manufacturing Practice standards, since a physical inspection is a mandatory part of the COS-8 approval.

Documents Required for Korean Face Serum Registration

A free sale certificate is required from the country of origin, which must be verified by the Indian Embassy or apostilled/notarised.

A complete list of all ingredients should be submitted, preferably in INCI format, in order of their predominance.

A letter of authority must be issued to the Indian importer by the Korean company, which has to be signed before a magistrate or the Indian Embassy in Korea.

Labels must comply with Indian regulations and contain the product name, batch number, date of manufacture, expiry date, price, country of origin, and import details.

The manufacturing premises and layout have to be provided, mentioning that the closure of the plant has taken place.

Proof of payment made for destinations through the Bharatkosh payment gateway. 

Step-by-Step Registration Process

For Imported Korean Face Serums (COS-1 → COS-2)

concern has to be laid on appointment of an agent for proper registration of the product 

The serum has to be registered on the SUGAM portal for registration

All products should be matched with the correct class of cosmetic being imported 

For Locally Manufactured Korean-Formulation Serums (COS-5 → COS-8)

Set up/identify a manufacturing premises conforming to Schedule M-II GMP requirements

Submit Form COS-5 along with the undertaking to the State Licensing Authority

Subject to document verification and inspection of the factory by the SLA

Attend to any observations made during the inspection

Receive Form COS-8 manufacturing (loan) licence upon approval 

Validity & Renewal

The validity  of COS-2 Import Registration Certificate is 5 years from the date of issue and needs to be renewed prior to expiry - Indian regulations do not recognize lapsed or retrospective registration certificates. On the other hand, the validity of COS-8 manufacturing licence is perpetual, although the license holder needs to pay a renewal fee within every five years failure to pay such renewal fee may result in suspension/cancellation of the licence by the SLA. 

Benefits of Registering Your Korean Face Serum with CDSCO

Right to import, distribute and sale of your product in one of the largest personal care markets

Confirmation to Indian distributors and marketplaces that your product complies with Indian regulatory requirements

Freedom from seizure, penalties and delisting of the product from e-commerce portals

Increased consumer confidence, as only registered products enjoy regulatory compliance 

Conclusion

Korean face serum registration with CDSCO in India is a one-off investment in compliance that safeguards your brand from future restrictions on selling your goods in India. Regardless of whether you're importing a face serum as a ready-made product under COS-1/COS-2 or manufacturing a face serum in India under COS-5/COS-8, your best bet to get approved in no time is to have all necessary documents ready and properly categorised, along with an authentic Free Sale Certificate and proper labelling.

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[silvereyecertifications]

CDSCO Registration for Patient Monitors in India: Complete Guide for Importers & Manufacturers

Patient monitors are generally notified as Class B (low-moderate risk) devices under the Medical Device Rules, 2017.

Manufacturers apply on Form MD-3 to their State Licensing Authority and receive the manufacturing license on Form MD-5.

Importers and foreign manufacturers apply on Form MD-14 to the Central Licensing Authority via the SUGAM portal and receive the import license on Form MD-15.

Both licenses remain valid indefinitely, subject to a mandatory retention fee every 5 years.

CDSCO registration of a patient monitor is the mandatory clearance by the Central Drugs Standard Control Organisation (CDSCO) of India, which is required before manufacturing, importing, selling, or distributing the patient monitor in India. Generally, the patient monitor falls under the Class B (low-moderate risk) devices as per the Medical Device Rules, 2017. The Indian manufacturer will need to submit Form MD-3 to his State Licensing Authority and acquire a Form MD-5 licence. On the other hand, the foreign manufacturer will have to assign an Authorised Agent having a wholesale license (Form MD-42) to submit Form MD-14 to the Central Licensing Authority via the SUGAM portal and get the Form MD-15 licence. 

Patient Monitor Classification Under CDSCO (Risk Class)

CDSCO follows a four-tier, GHTF-aligned risk classification system under Rule 4 of the MDR 2017: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk). The classification decides which form, licensing authority, and which documentation apply to your patient monitor CDSCO registration.

Class A (Low Risk): Stethoscopes, thermometers, tongue depressors.

Class B (Low-Moderate Risk): Patient monitors, blood pressure (BP) monitors, syringes, nebulisers.

Class C (Moderate-High Risk): Ventilators, infusion pumps, X-ray machines.

Class D (High Risk): Pacemakers, heart valves, drug-eluting stents.

Most standalone and bedside multi-parameter patient monitors are classified as Class B, licensed by the State Licensing Authority (SLA). However, classification depends on the device's exact intended use and its listing in CDSCO's dynamic notified device list, so always verify the current classification of your specific patient monitor model before filing your CDSCO registration application.

Who Needs CDSCO Registration for a Patient Monitor?

Patient monitors manufactured in India by Indian manufacturers

Foreign manufacturers exporting Patient Monitors to India (via an Indian Authorised Agent)

Importers and Distributors of Patient Monitors for Sale for Commercial Purpose in India

Hospitals or research institutions importing specialised monitors for their own clinical or investigational use 

Eligibility Criteria for Patient Monitor CDSCO Registration

A legally registered business entity in India or an Indian Authorised Agent for foreign manufacturers

A valid Wholesale License (Form MD-42) in possession of the importer or Indian Agent

Quality Management System, ISO 13485:2016 certified

Manufacturing site is compliant with the Fifth Schedule of MDR 2017 (for domestic manufacturers)

Free Sale Certificate from country of origin (valid) (for patient monitors imported

Documents Required for CDSCO Registration of Patient Monitor

For Manufacturers (Form MD-3 / MD-5)

Site Master File and Device Master File

ISO 13485:2016 certificate

Test license copy (where applicable) and essential principles compliance checklist

Labels, Instructions for Use (IFU), and product literature

Undertaking of compliance with the Fifth Schedule (QMS requirements)

For Importers / Foreign Manufacturers (Form MD-14 / MD-15)

Power of Attorney authorising the Indian Authorised Agent

Free Sale Certificate from the regulatory authority of the country of origin

ISO 13485:2016 certificate and CE certificate/marketing authorisation, where available

Device Master File and Plant Master File

Wholesale License (Form MD-42) of the Indian Authorised Agent

Labels, IFU, and covering letter

Step-by-Step CDSCO Registration Process for Patient Monitor

Manufacturing License Process (Form MD-3 to Form MD-5)

Confirm the patient monitor's risk class and check the CDSCO-notified device list

Prepare the Device Master File, Plant Master File, and QMS documentation

Register on the SUGAM portal and file Form MD-3 with the State Licensing Authority

Pay the applicable government fee online

Undergo a Notified Body audit of the manufacturing site against the Fifth Schedule

Resolve any queries or non-conformities raised during scrutiny

Receive the manufacturing license on Form MD-5 (typically 4-6 months)

Import License Process (Form MD-14 to Form MD-15)

Appoint an Indian Authorised Agent holding a valid MD-42 wholesale license

Compile the Free Sale Certificate, ISO 13485 certificate, Device Master File, and Plant Master File

File Form MD-14 on the SUGAM portal along with labelling and IFU documents

Pay the applicable government import license fee

Respond to CDSCO deficiency letters or queries within the given timeframe

Receive the import license on Form MD-15 once approved

CDSCO Registration Fees for Patient Monitor

Manufacturing Site Registration (Form MD-3, Class B): ₹5,000 per manufacturing site.

Additional Device Fee (Class B): ₹500 per product/model.

Import License (Form MD-14): Fee varies depending on the device class and the number of products included in the application.

License Retention Fee: Payable every 5 years to maintain an active license.

Government fees are revised periodically by the Ministry of Health and Family Welfare. Always confirm the current fee schedule on the official CDSCO SUGAM portal before filing your patient monitor CDSCO registration application.

Validity & Renewal Timeline

MD-5 Manufacturing License (Class B):

Authority: State Licensing Authority (SLA)

Validity: Indefinite, subject to payment of the retention fee every 5 years.

Renewal/Retention: File the retention fee application 3–6 months before the due date.

MD-15 Import License:

Authority: Central Licensing Authority (CLA)

Validity: Indefinite, subject to payment of the retention fee every 5 years.

Renewal/Retention: File the retention fee application 3–6 months before the due date.

Benefits of CDSCO Registration for Patient Monitor

Legal authorisation to manufacture, import, sell, or distribute patient monitors across India

Smoother customs clearance for imported patient monitor consignments

Stronger credibility with hospitals, distributors, and government tenders

Protection from product seizure, penalties, and legal action under MDR 2017

A documented Quality Management System that supports export readiness

Conclusion

Getting a patient monitor CDSCO registration involves a defined, yet paperwork-intensive process, based on correct Class B classification, a compliant Device Master Record and consistent documentation across all forms. Manufacturers through Form MD-3 to MD-5 to their State Licensing Authority. Importers & foreign manufacturers through Form MD-14 to MD-15 to the Central Licensing Authority through SUGAM. Please check the latest requirements on the official CDSCO SUGAM portal before applying, as the fees, timelines and classification lists are updated from time to time.

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[silvereyecertifications]

BIS Certification for Cross Recessed Screws: Complete 2026 QCO Amendment Guide

Mandatory under the Cross Recessed Screws (QCO) 2025, superseded and amended in 2026

Covers pan head, countersunk, raised countersunk, wood, drywall and chipboard screws

Manufacturers use BIS Scheme-I; importers use the FMCS route via an Authorised Indian Representative

2026 amendment defers 3 screw categories by 3 years; all remaining categories stay mandatory.

What Is BIS Certification for Cross Recessed Screws?

The BIS certification for cross recessed screws is compulsory, provided by the Bureau of Indian Standards(BIS) and enables the manufacturer or importer to affix the ISI mark on the pan head, countersunk, raised countersunk, wood, drywall and chipboard screws marketed in India. The certification guarantees that the screws meet the requirements of the specific Indian Standard, such as IS 18471 (Parts 1 – 3) and IS 18509 for countersunk wood screws. Failure to have this certification makes manufacturing, import, distribution and sale of the cross recessed screws in India an offence according to the BIS Act, 2016.

Why the Cross Recessed Screws QCO Matters

Cross recessed screws have many applications in construction, electrical fittings, appliances, the automobile, and furniture industries. An inferior screw is capable of leading to damage in the structures or products in which they have been used. This QCO was formulated to ensure that inferior screws are eliminated from the market and that quality standards of Indian screws are up to ISO standards.

Cross Recessed Screws QCO: Timeline of Orders

Cross Recessed Screws (QCO), 2024

Notification Date: 20 September 2024

First Quality Control Order (QCO) making BIS certification mandatory for Cross Recessed Screws.

Cross Recessed Screws (QCO), 2025

Notification Date: 27 August 2025

Superseded the 2024 QCO.

Introduced a consolidated order covering 14 categories of Cross Recessed Screws.

Cross Recessed Screws (QCO) Amendment, 2026

Notification Date: 2026

Superseded the 2025 QCO.

Provides a 3-year exemption for Serial Numbers 12, 13, and 14 (Drywall Screws, Chipboard Screws, and Countersunk Wood Screws).

All other provisions of the 2025 QCO remain effective and mandatory.

Products Covered Under the QCO

Pan head, countersunk head, and raised countersunk head screws

Hexagon washer head self-drilling screws

Drywall screws, chipboard screws and countersunk wood screws

Steel, stainless steel and non-ferrous metal cross recessed screws

Applicable Indian Standards

Cross Recessed Drilling Screw – Pan Head

Applicable Indian Standard: IS 18471 (Part 1): 2023 / ISO 15481

Cross Recessed Drilling Screw – Countersunk Head

Applicable Indian Standard: IS 18471 (Part 2): 2023 / ISO 15482

Cross Recessed Drilling Screw – Raised Countersunk Head

Applicable Indian Standard: IS 18471 (Part 3): 2023 / ISO 15483

Cross Recessed Countersunk Head Wood Screw

Applicable Indian Standard: IS 18509: 2023

Exemptions From BIS Certification

Items produced solely for exports

Screws imported by OEMs up to 200 kg per annum exclusively for research and development (and not for sale), on an annual basis (with proper documentation)

Screws imported as an integral part of a finished product/sub-assembly/component

Very small-scale Udyam registered firms with investment of up to ₹25 lakh and turnover of up to ₹2 crore, certified by a Chartered Accountant.

BIS Certification Process for Domestic Manufacturers (Scheme-I)

Determine the relevant Indian Standard for your specific type and grade of screws

Establish test facilities within the factory as per requirements of that standard

Obtain BIS license through online portal – Manak Online / BIS Care for Scheme-I of Schedule-II

Factory inspection and sample testing done by BIS

Granting of license by BIS after successful audit and test results

Marking of ISI logo on the item is permitted thereafter

Documents Required

Proof of Business Registration (Certificate of Incorporation / Udyam registration / GST certificate)

Factory plan, manufacturing process diagram, and list of machines used

Test report from the laboratory which is either accredited or in-house as per applicable IS

QC Manual and Calibration report of test equipment used

Importers: Proof of overseas factory address and details of Authorised Indian Representative

Fees, Validity and Renewal

The BIS licence fees include application fees, licence fees depending upon the category of the product and the turnover and annual marking fees as per the current fee structure of BIS, available on the Manak Online portal; and this fee structure keeps getting updated from time to time, so it is advisable for the applicant to check the current fee slab from the BIS at the time of applying for the licence. A Scheme-I or FMCS licence validity may vary as per the choice of the licensee, but usually it may be for one year or two years and needs to be renewed at the end of the validity period.

Penalties for Non-Compliance

Manufacturing, importing, selling, or distributing notified cross recessed screws without a valid BIS licence is punishable under the BIS Act, 2016, and can attract fines and legal action, along with seizure of non-compliant stock and denial of customs clearance for import consignments.

Conclusion

Under the QCO 2026 Amendment, BIS certification is compulsory for compliance in the case of Cross Recessed Screws falling within the notified standards. It would be prudent for manufacturers and importers to ensure that they confirm the relevant Indian Standard and undertake the certification process to comply before releasing their products into the Indian market.

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