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BIS CRS Registration for LED Lights 2026: Complete Guide for Manufacturers & Importers

What you will learn in this guide:

BIS has revised IS 10322 (Part 5) series standards — all existing licences must comply by 02 August 2026.

7 LED luminaire categories are covered under the updated Compulsory Registration Order (CRO), including street lights, flood lights, emergency lights and more.

CRS licence is now valid for 5 years with annual fee payment — effective from 25 February 2026, BIS regulation amendment.

Step-by-step process, documents, fees, and 10 expert FAQs to help manufacturers and importers get registered without delays.

1. What Is BIS CRS Registration for LED Lights?

BIS CRS (Compulsory Registration Scheme) is a mandatory product certification system governed by the Bureau of Indian Standards under the BIS Act, 2016. LED lights fall under the Compulsory Registration Order (CRO) notified by the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry.

If you manufacture or import any LED luminaire covered under the CRO, you are legally required to obtain BIS CRS registration before selling the product in India. Selling LED lights without a valid BIS CRS licence is a punishable offence under Indian law.

Key terms to understand:

BIS: Bureau of Indian Standards — the national standards body of India.

CRS: Compulsory Registration Scheme — mandatory product certification for specified electronics and IT goods.

CRO: Compulsory Registration Order — the official government notification listing products that require BIS CRS.

IS 10322: Indian Standard for luminaires, now revised in 2026, covering LED-specific safety and performance requirements.

2. 2026 Update: Revised IS 10322 Standards & What Has Changed

This is the most important update of 2026 for LED light manufacturers and importers. BIS issued official guidelines on 20 March 2026, revising the IS 10322 (Part 5) series standards for LED luminaires. All revised standards carry a final implementation deadline of 02 August 2026.

LED Product Categories Covered Under Revised Standards (2026)

Fixed General Purpose LED Luminaires & Fancy Lights

Old Standard: IS 10322 (Part 5/Sec 1): 2012 + IEC 60598-2-1:2020

Revised Standard: IS 10322 (Part 5/Sec 1): 2026

Compliance Deadline: 02 August 2026

Recessed LED Luminaires

Old Standard: IS 10322 (Part 5/Sec 2): 2012 + IEC 60598-2-2:2023

Revised Standard: IS 10322 (Part 5/Sec 2): 2026

Compliance Deadline: 02 August 2026

LED Luminaires for Road & Street Lighting

Old Standard: IS 10322 (Part 5/Sec 3): 2012 + IEC 60598-2-3:2002

Revised Standard: IS 10322 (Part 5/Sec 3): 2026

Compliance Deadline: 02 August 2026

LED Flood Lights

Old Standard: IS 10322 (Part 5/Sec 5): 2013 + IEC 60598-2-5:2015

Revised Standard: IS 10322 (Part 5/Sec 5): 2026

Compliance Deadline: 02 August 2026

LED Hand Lamps

Old Standard: IS 10322 (Part 5/Sec 6): 2013 + IEC 60598-2-8:2013

Revised Standard: IS 10322 (Part 5/Sec 6): 2026

Compliance Deadline: 02 August 2026

LED Lighting Chains

Old Standard: IS 10322 (Part 5/Sec 7): 2017 + IEC 60598-2-20:2022

Revised Standard: IS 10322 (Part 5/Sec 7): 2026

Compliance Deadline: 02 August 2026

LED Luminaires for Emergency Lighting

Old Standard: IS 10322 (Part 5/Sec 8): 2013 + IEC 60598-2-22:2022

Revised Standard: IS 10322 (Part 5/Sec 8): 2026

Compliance Deadline: 02 August 2026

Key Technical Changes in IS 10322 (Part 1): 2026

IS 10322 (Part 1):2026 is the base/parent standard. Its revision introduces the following significant changes that directly affect product design, testing, and compliance:

Introduction of IPX9 ingress protection rating requirements 

EMF (Electromagnetic Field) safety requirements are now included 

Marking requirements for all luminaires have been modified, somewhat noticeably 

There is a new clause for protection against fast-rotating parts (for instance, moving fan blades) 

PELV (Protective Extra-Low-Voltage) system requirements have been added 

Extra requirements now apply to luminaires that use controllable control gear providing SELV outputs 

Limits for touch voltage and touch current have been added to electric shock risk tests 

A new informative annexure is added for luminaires powered via IT communication cabling (PoE) 

A new normative annexure is included for battery and EDLC-operated luminaires 

Photo-Biological safety requirements have been extended  

Notable Product-Specific Changes

Beyond the base standard, each product section has targeted updates:

Recessed Luminaires (Sec 2): new requirements are in place for air handling luminaires and also extra marking, kinda like additional identification. 

Street Lighting (Sec 3): More marking is required, and it matches road infrastructure standards, so it’s more aligned than before. 

Flood Lights (Sec 5): a glass-breaking test has been added; this is now a fresh safety requirement. 

LED Lighting Chains (Sec 7): There are specific provisions added for Temporarily Installed Protected (TPL) chains. 

Emergency Lighting (Sec 8): new requirements show up for lithium batteries, EDLCs, and the rest/inhibiting mode tests are updated too, yes, with changes to how those modes are checked. 

3. BIS CRS Licence Validity: New 5-Year Rule (2026 Amendment)

Effective from 25 February 2026, BIS amended the BIS (Conformity Assessment) Regulations, 2018 under Scheme-II. This is a significant update for both new applicants and existing licensees.

Initial Licence Validity

BIS licence is granted initially for 5 years.

Renewal Period

The licence can be renewed for an additional 5-year period upon successful renewal.

Fee Payment Schedule

Annual licence fees must be paid in advance by the prescribed due date.

Non-Payment Consequence

Failure to pay the required fees may result in:

Suspension or deferment of the licence.

Cancellation or expiry of the licence.

Production Details Submission

Licensees must submit production details along with the annual fee payment as per BIS requirements.

Important: If the annual fee along with production details is not received by the due date, provisions regarding suspension and cancellation of the licence shall apply as per BIS (Conformity Assessment) Regulations, 2018, as amended. Ensure timely payment to avoid disruption to your business.

4. Who Needs BIS CRS Registration for LED Lights?

The following entities are legally required to obtain BIS CRS registration for LED lights in India:

Indian Manufacturers: Any company manufacturing LED luminaires covered under CRO for sale in India.

Importers: Any business importing LED lights from China, Taiwan, South Korea, or any other country for sale in Indian markets.

Brand Owners / Private Label Sellers: Businesses that get products manufactured under their brand and sell in India.

OEM Suppliers: Original equipment manufacturers supplying LED luminaires to other companies for resale.

Who is exempt? Products manufactured exclusively for export are generally not required to carry the BIS Standard Mark. However, any LED light product sold in India under the CRO must have a valid BIS CRS registration.

5. Eligibility Criteria for BIS CRS LED Light Registration

Before applying, ensure you meet the following eligibility conditions:

The applicant must be a legally registered business entity in India (for Indian manufacturers) or have a valid Authorised Indian Representative (AIR) for foreign manufacturers/importers.

The LED product must be covered under the applicable IS 10322 standard (Part 5, respective sections).

The product must be tested at a BIS-recognised laboratory and pass all requirements of the applicable standard.

The applicant must be capable of ensuring ongoing conformity of the product to the relevant standard.

For foreign manufacturers: The AIR must be a resident Indian entity holding a valid Power of Attorney from the foreign manufacturer.

6. Documents Required for BIS CRS LED Light Registration

For Indian Manufacturers

The applicant has to be a legally registered business entity in India ( especially for Indian manufacturers ) or, for foreign manufacturers/importers, they need a valid Authorised Indian Representative, AIR. 

The LED product has to fall under the applicable IS 10322 standard ( Part 5, with its respective sections ). 

The product needs to be tested at a BIS-recognised laboratory, and it should meet or pass every requirement mentioned in the applicable standard. 

The applicant must also be able to maintain ongoing conformity, meaning the product keeps complying with the relevant standard over time, not only at the first stage. 

For foreign manufacturers, the AIR has to be a resident Indian entity that holds a valid Power of Attorney granted by the foreign manufacturer. 

For Importers / Foreign Manufacturers

All documents listed above for Indian manufacturers

Authorised Indian Representative (AIR) agreement / Power of Attorney

AIR's company registration and address proof in India

Foreign manufacturer's registration/incorporation proof

Product origin declaration

Import documents (where applicable)

7. Step-by-Step BIS CRS Registration Process for LED Lights

Product Selection & Standard Identification: Identify the correct IS 10322 (Part 5) section applicable to your LED product category. As of 2026, all testing must be done as per the revised 2026 standards.

Sample Preparation & Testing: Prepare product samples for testing. Submit to a BIS-recognised laboratory. The lab will test the product as per IS 10322 (Part 5/Sec X): 2026. Obtain the official test report. Note: For existing licensees who previously tested under old standards, fresh testing under the revised standard is mandatory.

Online Application on BIS Portal: Register on the BIS CRS online portal (www.bis.org.in). Fill the application form with all product and company details. Upload all required documents.

Application Fee Payment: Pay the prescribed application fee online. Application fee varies by product category and number of models.

BIS Scrutiny & Grant of Licence: BIS scrutinises the application and test reports. If all requirements are met, BIS grants the CRS licence. The licence is valid for 5 years with annual fee payments.

Mark the Product: Once the licence is granted, mark all LED products with the BIS Standard Mark (ISI Mark) and the registration/licence number as per marking requirements.

Annual Compliance: Pay annual licence fees in advance by the due date. Submit production details annually. Ensure ongoing product conformity to the revised standards.

8. BIS CRS Registration Fees for LED Lights

BIS charges registration fees at multiple stages. Here is a general fee structure overview. Note: Exact fees are subject to revision by BIS. Always check the latest fee schedule at bis.org.in before applying.

Application / Grant of Licence Fee

Applicable at the time of submitting the licence application.

Payment is made online through the BIS Portal.

Annual Licence Fee

Payable every year in advance before the prescribed due date.

Payment is made online through the BIS Portal.

Renewal Fee

Payable at the time of licence renewal after the initial 5-year validity period.

Payment is made online through the BIS Portal.

Testing Fee (Laboratory Charges)

Paid directly to a BIS-recognised testing laboratory.

Charges are applicable as per the laboratory's approved fee schedule.

Change in Scope Fee

Applicable when adding new models, variants, or products under an existing licence.

Payment is made online through the BIS Portal.

Tip: Failure to pay the annual fee by the due date triggers suspension and eventual cancellation of your BIS CRS licence. Set calendar reminders for your annual fee due dates.

9. Implementation Guidelines: What Existing Licensees Must Do Before 02 August 2026

If you already hold a BIS CRS licence for LED luminaires, here is what you must do to stay compliant with the revised IS 10322 standards:

Step 1 — Get Fresh Test Reports: Submit all lead model(s) in your current licence scope for retesting at a BIS-recognised laboratory under the applicable revised IS 10322:2026 standard. Submit complete test reports to BIS.

Step 2 — Submit Undertaking: Provide a signed undertaking to BIS confirming that all other series model(s) in your licence scope have been updated to conform to the applicable revised standard.

Step 3 — Complete Before 02 August 2026: All the above actions must be completed before 02 August 2026. Beyond this date, any licence without confirmed compliance to the revised standard may be cancelled, or models may be deleted from scope.

Warning: BIS has clearly stated — beyond the last date of concurrent running (02 August 2026), no licence shall remain operative where compliance with the Revised Standard has not been ensured by the licensee. Do not wait until the last minute.

10. Guidelines for New Applicants (2026)

If you are a new applicant for BIS CRS LED light registration, here is what applies as of 2026:

If your sample has already been submitted to a BIS-recognised laboratory or a test report has been issued, your application may be processed under the applicable old standard.

New applications recorded from now onwards may be processed under either the old or revised standard — but only until 02 August 2026. Processing under the old standard beyond this date is not permitted.

If applying under the old standard before 02 August 2026, you must give a declaration committing to implement the revised IS 10322:2026 standard by 02 August 2026.

After 02 August 2026, all new applications will only be processed under the revised IS 10322:2026 standards.

11. Key Benefits of BIS CRS Registration for LED Lights

Legal Compliance

Ensures compliance with the mandatory requirements under the Compulsory Registration Scheme (CRS).

Helps avoid penalties, product seizure, import restrictions, and legal action.

Market Access

Mandatory for selling LED lighting products across Indian retail, wholesale, and B2B markets.

Consumer Trust

The BIS Standard Mark demonstrates that the product meets recognised safety and quality standards.

Enhances consumer confidence and trust.

E-commerce Listing

Major online marketplaces such as Amazon and Flipkart generally require BIS CRS compliance for LED product listings.

Government Tenders

BIS CRS certification is often a prerequisite for participation in government and public sector procurement projects.

Brand Credibility

Certified products enjoy greater market acceptance, improved customer confidence, and the potential to command premium pricing.

Conclusion: Act Now Before 02 August 2026

BIS CRS registration for LED lights is not optional — it is a legal requirement for every manufacturer and importer operating in India. The 2026 revision of IS 10322 standards brings meaningful technical upgrades that improve product safety and performance. Whether you are an existing licensee or a new applicant, the most important action right now is to ensure your products are tested and compliant with the revised IS 10322:2026 standards before 02 August 2026.

With the new 5-year licence validity and annual fee model, staying compliant is easier than ever — but only if you act on time. Get your test reports, submit your documentation, and secure your BIS CRS licence to keep your LED light business running legally and profitably in India.

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

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CE Marking Registration: Complete Guide to Get CE Certified in 2026

CE Marking is mandatory for products sold in the European Economic Area (EEA) — no CE mark means no legal sale.

The registration process covers compliance with EU directives, product testing, technical documentation, and issuing a Declaration of Conformity.

Depending on the product risk level, you may need a Notified Body to assess and certify your product.

CE Marking has no fixed expiry — but it must be reviewed whenever the product design or applicable EU directive changes.

What Is CE Marking Registration?

CE Marking registration is the process by which manufacturers confirm their products meet EU safety, health, and environmental protection standards. The CE mark — short for Conformité Européenne — allows products to move freely across all 30 EEA countries. It is not a quality mark or a government approval stamp; it is a manufacturer's declaration that the product complies with applicable EU directives. Without a valid CE mark, it is illegal to sell regulated products in the EU market.

1. What Is CE Marking? (And Why Does It Matter in 2026?)

CE Marking, you know, like the little mark everyone talks about, stands for Conformité Européenne. Basically, it means “European Conformity”, and it is not just some optional badge; it’s a mandatory certification mark for products that are sold in the European Economic Area, the EEA. That covers the 27 EU countries as well as Norway, Iceland, and Liechtenstein, so it’s more than only “EU”.  

So the real idea behind the CE mark is that regulators, distributors, and even consumers can see that the product has been checked against the right EU directives, and that it actually satisfies the needed safety plus performance requirements. In other words, it works like your product’s legal passport to reach the European market, even if some people still treat it like paperwork.  

In 2026, the CE Marking situation is, well, it has gotten more strict. The EU has updated directives for machinery, medical devices, and electrical equipment. And regulators across the region are doing more market surveillance, so if something is not compliant, the consequences can be pretty harsh, like product seizure, fines, or the product being banned from sale.  

Why CE Marking Matters (for real)

• Legal must-have: if you don’t have CE Marking, you cannot put the product on the EEA market legally  

• Easier entry to customers: it gives access to roughly 450 million consumers across 30 EEA countries, not a small thing  

• Builds confidence: it tells people your product aligns with EU health, safety and environmental rules  

• Smoother trade: it can make customs and importing simpler across member states  

• Shows care and responsibility: in case of an incident, it helps prove due diligence

2. Which Products Require CE Marking? (High-Search Products Table)

Not every product sold in Europe needs CE Marking — only those covered by specific EU directives. Here are the most commonly searched product categories that require CE certification:

CE Marking Product Categories & Applicable EU Regulations

Electronic & Electrical Equipment

Applicable Directive: Low Voltage Directive (LVD) 2014/35/EU

Notified Body Required: No (Self-Declaration)

Estimated Search Volume: High

Machinery & Industrial Equipment

Applicable Directive: Machinery Directive 2006/42/EC

Notified Body Required: Yes (Annex IV Products)

Estimated Search Volume: High

Medical Devices

Applicable Regulation: MDR 2017/745

Notified Body Required: Yes (Mandatory)

Estimated Search Volume: Very High

Personal Protective Equipment (PPE)

Applicable Regulation: PPE Regulation (EU) 2016/425

Notified Body Required: Yes (Category II & III)

Estimated Search Volume: High

Toys

Applicable Directive: Toy Safety Directive 2009/48/EC

Notified Body Required: Yes (Chemical & Flammability Assessment)

Estimated Search Volume: High

Construction Products

Applicable Regulation: Construction Products Regulation (CPR) 305/2011

Notified Body Required: Yes

Estimated Search Volume: Medium-High

Radio & Wireless Equipment

Applicable Directive: Radio Equipment Directive (RED) 2014/53/EU

Notified Body Required: No (Mostly Self-Declaration)

Estimated Search Volume: High

Pressure Equipment

Applicable Directive: Pressure Equipment Directive (PED) 2014/68/EU

Notified Body Required: Yes (Higher-Risk Equipment)

Estimated Search Volume: Medium

In-Vitro Diagnostic Devices (IVDs)

Applicable Regulation: IVDR 2017/746

Notified Body Required: Yes (Mandatory)

Estimated Search Volume: Medium-High

Gas Appliances

Applicable Regulation: Gas Appliances Regulation (EU) 2016/426

Notified Body Required: Yes (Mandatory)

Estimated Search Volume: Medium

Lifts & Elevators

Applicable Directive: Lifts Directive 2014/33/EU

Notified Body Required: Yes

Estimated Search Volume: Medium

Measuring Instruments

Applicable Directive: Measuring Instruments Directive (MID) 2014/32/EU

Notified Body Required: Yes

Estimated Search Volume: Medium

Note: Products can fall under multiple directives. For example, a wireless medical device may need to comply with both MDR 2017/745 and the Radio Equipment Directive (RED) 2014/53/EU simultaneously.

3. Key Benefits of CE Marking Registration

Single Market Access: you can offer your product across all 30 EEA countries using just one certification—less paperwork, no need for approvals country-by-country.  

Legal Compliance: It helps keep your business safe from regulatory fines, product recalls, and even market bans.  

Competitive Advantage: distributors and retail buyers in Europe often look for certified goods first, so you become the obvious choice.  

Reduced Liability: CE Marking shows your product is in line with EU safety expectations, which can lessen your exposure if something goes wrong.  

Brand Credibility: CE Marking adds credibility with both B2B and B2C customers in European markets, not just “a check box”.  

Customs Clearance: Importing and distributing inside the EEA tends to move faster when the documentation is in order.  

Long-Term Market Presence: it sets up a lasting base for sustainable growth in the world's biggest single market.

4. CE Marking Requirements and Eligibility

CE marking is for manufacturers, importers, and authorised representatives who put regulated products on the EEA market. Basically, if you’re placing the product there, you’re in the picture.  

Who actually needs CE marking?  

Manufacturers set up inside or outside the EU, when they sell into the EEA market  

Importers bringing products from non-EU countries into the EEA, so they can be sold  

Authorised Representatives who were appointed by non-EU manufacturers  

Distributors that modify a product or rebrand it, because then they take on manufacturer duties, in practice  

Basic eligibility requirements  

Your product has to fit under at least one relevant EU directive or regulation  

The product must satisfy all the essential requirements set out in the applicable directive  

You need to have the full technical documentation ready before you affix the CE mark  

A Declaration of Conformity should be signed by an authorised person  

The product must show the CE mark in a visible, readable, and durable way 

5. Documents Required for CE Marking Registration

The documentation pack you prepare is called the Technical File or Technical Construction File (TCF). This must be kept for a minimum of 10 years after the last product is placed on the market.

CE Marking Documentation Requirements

Technical File / Technical Documentation

Full product description, drawings, schematics, and component list

Mandatory: Yes

EU Declaration of Conformity (DoC)

Signed declaration confirming compliance with applicable EU directives and regulations

Mandatory: Yes

Risk Assessment Report

Identification of product hazards and risk mitigation measures

Mandatory: Yes

Test Reports

Laboratory test results demonstrating compliance with harmonised EU standards

Mandatory: Yes

Instruction Manual (Local Language)

User instructions, safety guidelines, operation, and installation details

Mandatory: Yes

List of Applicable EU Directives & Standards

Details of harmonised standards applied (e.g., EN 60335, EN 61010, EN 60601)

Mandatory: Yes

Notified Body Certificate

Certificate issued by an authorised Notified Body for regulated or high-risk products

Mandatory: Conditional

Quality Management Documentation

Quality system records, such as ISO 9001, ISO 13485, or equivalent certifications

Mandatory: Conditional

Bill of Materials (BoM)

Detailed list of components, materials, and supplier information

Mandatory: Recommended

Product Labels & Markings

CE Mark, manufacturer details, model information, warnings, and traceability markings

Mandatory: Yes

6. CE Marking Registration Process: Step-by-Step

Here is how you can get your product CE marked in 2026:

Find EU Directives for Your Product: Check which EU directives apply to your product. Your product might have to follow directives at the same time.

Understand Requirements: Read each directive to know the safety, performance and environmental requirements for your product.

Check European Standards: Look for European standards (EN standards) for your product. Following these standards helps show your product meets the requirements.

Test and Assess Your Product: Test your product against the standards. You can do this in-house or with a third-party laboratory that is accredited.

See If You Need a For products with higher risks, like medical devices or certain machinery, you need an EU-approved Notified Body to check if your product is safe.

Prepare Technical Documents: Make a Technical File with test results, risk assessments, drawings and information about the components.

Make an EU Declaration of Conformity: Sign the Declaration of Conformity to say your product meets all the directives. This document must include your company name, a description of your product, the directives you followed, the standards you used and the name of the person who signed it.

Put the CE Mark on Your Product: Apply the CE mark to your product, its packaging or the documents that come with it, following the marking rules.

Register with EU Authorities (if needed): Some products, like medical devices, need to be registered in the EUDAMED database or national authority databases.

Monitor Your Product: Keep an eye on your product's performance and safety after it is on the market. Update your documents if your product or the directives change.

7. CE Marking Registration Fees: How Much Does It Cost?

CE Marking itself is not a paid certification with a government fee — it is a self-declaration process. However, the total cost includes testing, documentation preparation, Notified Body fees (if required), and ongoing compliance management.

CE Marking Cost Breakdown

Product Safety Testing (Third-Party Laboratory)

Estimated Cost: $1,500 – $15,000+

Notes: Cost depends on product complexity, testing requirements, and applicable standards.

Notified Body Assessment

Estimated Cost: $3,000 – $50,000+

Notes: Required only for high-risk products that need third-party conformity assessment.

Technical Documentation Preparation

Estimated Cost: $1,000 – $8,000

Notes: Costs can be reduced if documentation is prepared internally.

Consultant / Compliance Expert Fees

Estimated Cost: $2,000 – $20,000

Notes: Optional but highly recommended for companies new to CE compliance.

Translation of Documents & Manuals

Estimated Cost: $500 – $3,000

Notes: Required for each applicable language in the European Economic Area (EEA).

Quality Management System (QMS) Implementation

Estimated Cost: $5,000 – $25,000

Notes: May include ISO 9001 or other relevant standards; mandatory for certain product categories such as medical devices.

EUDAMED Registration (Medical Devices)

Estimated Cost: Free (System Access)

Notes: Mandatory registration for medical device manufacturers and authorised representatives.

Annual Surveillance / Renewal Audits

Estimated Cost: $1,000 – $10,000

Notes: Applicable to products certified through a Notified Body and subject to ongoing compliance monitoring.

Total estimated cost for a simple electrical product: $2,000 – $10,000. For complex medical devices: $50,000 – $250,000+.

8. CE Marking Validity and Renewal Timeline

Does CE Marking Expire?

CE Marking does not have a fixed expiry date. However, it must be reviewed and potentially updated in the following situations:

The product design or technical specifications change

The applicable EU directive is revised or replaced

The harmonised standards used are updated or withdrawn

A Notified Body certificate reaches its defined expiry (typically 3–5 years)

Post-market surveillance identifies new safety concerns

Significant changes to the EU regulatory framework occur

Renewal Timeline Guide

CE Marking vs UKCA Marking

Geographic Scope

CE Marking: Valid across the European Economic Area (EEA) – 30 countries.

UKCA Marking: Applicable only in Great Britain (England, Scotland, and Wales).

Regulatory Authority

CE Marking: Governed by the European Commission.

UKCA Marking: Governed by the UK Government through the Office for Product Safety and Standards (OPSS).

Conformity Assessment Bodies

CE Marking: Uses EU-designated Notified Bodies.

UKCA Marking: Uses UK Approved Bodies.

Declaration of Conformity (DoC)

CE Marking: Requires an EU Declaration of Conformity.

UKCA Marking: Requires a UK Declaration of Conformity.

Technical Standards

CE Marking: Based on EN Harmonised Standards.

UKCA Marking: Based on UK-Designated Standards, which are often aligned with EN standards.

Transition Timeline

CE Marking: Generally accepted in Great Britain until 31 December 2027 for most products.

UKCA Marking: Expected to become the primary mandatory marking for most products from January 2028.

Northern Ireland

CE Marking: Continues to be accepted under the Windsor Framework arrangements.

UKCA Marking: Not applicable as the primary marking for placing goods on the Northern Ireland market.

9. What Is a Notified Body? (And When Do You Need One?)

A Notified Body is an organisation designated by an EU member state to carry out conformity assessment procedures for specific product categories. They are listed in the NANDO (New Approach Notified and Designated Organisations) database maintained by the European Commission.

When Is a Notified Body Mandatory?

•        Medical devices and in-vitro diagnostics (under MDR/IVDR) — mandatory for all classes except Class I non-sterile, non-measuring

•        Personal Protective Equipment: Category II and Category III products

•        Machinery: Products listed in Annex IV of the Machinery Directive

•        Gas appliances: All CE-marked appliances

•        Pressure equipment: SEP and higher categories

•        Lifts: All passenger lifts

How to Choose a Notified Body

•        Check the NANDO database (ec.europa.eu/growth/tools-databases/nando) for accredited bodies

•        Confirm the body is notified for your specific directive and product category

•        Compare fees, turnaround times, and technical expertise

•        Verify their accreditation is current and recognised in your target countries

10. CE Marking vs UKCA Marking: Key Differences (2026 Update)

Since Brexit, the UK has its own product marking system — UKCA (UK Conformity Assessed). If you sell in both the EU/EEA and the UK, you may need both marks.

CE Marking vs UKCA Marking – Key Differences

Geographic Scope

CE Marking: Valid in the European Economic Area (EEA) covering 30 countries.

UKCA Marking: Applicable only in Great Britain (England, Scotland, and Wales).

Regulatory Authority

CE Marking: Regulated by the European Commission.

UKCA Marking: Regulated by the UK Government through the Office for Product Safety and Standards (OPSS).

Conformity Assessment Bodies

CE Marking: EU-designated Notified Bodies.

UKCA Marking: UK Approved Bodies.

Declaration of Conformity (DoC)

CE Marking: Requires an EU Declaration of Conformity.

UKCA Marking: Requires a UK Declaration of Conformity.

Technical Standards

CE Marking: Based on EN Harmonised Standards.

UKCA Marking: Based on UK-Designated Standards, which are often identical to EN standards.

Transition Period

CE Marking: Continues to be accepted in Great Britain for most products until 31 December 2027.

UKCA Marking: Expected to become mandatory for most products from January 2028.

Northern Ireland

CE Marking: Accepted under the Windsor Framework arrangements.

UKCA Marking: Not applicable as the primary conformity marking for the Northern Ireland market.

11. Common CE Marking Mistakes to Avoid

Affixing the CE mark without completing the full conformity assessment process

Using outdated or withdrawn harmonised standards in technical documentation

Missing applicable directives (e.g., forgetting EMC requirements for electronic products)

Incomplete Declaration of Conformity — missing required elements defined in the directive

Failing to maintain technical documentation for the required retention period (10 years)

Not updating CE documentation when product design changes are made

Relying on a Notified Body certificate alone without proper in-house documentation

Incorrect CE mark placement — mark must be visible, legible, and permanent

Final Thoughts: CE Marking Registration in 2026

CE Marking registration is not just a compliance checkbox — it is your gateway to one of the world’s most lucrative consumer markets. Whether you are a manufacturer in Asia, the Americas, or Europe itself, getting your CE certification right from the start saves time, money, and legal risk down the road.

The process requires careful identification of applicable directives, thorough product testing, complete technical documentation, and — where required — engagement with an accredited Notified Body. With EU regulatory enforcement intensifying in 2026, especially in medical devices, machinery, and electrical equipment, early and accurate compliance is more important than ever.

If you are unsure where to start, consult a qualified EU compliance expert or Authorised Representative to guide your specific product through the right conformity assessment route.

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 CDSCO Manufacturing Test License: MD-12 & MD-13 Guide

CDSCO Manufacturing Test License (MD-12/MD-13): Complete Registration Guide 2026

MD-12 is the application form, and MD-13 is the test license that CDSCO gives for manufacturing small batches of Class A, B, C, or D medical devices.  

Applications are done online through the NSWS portal  ( nsws.gov.in ), and the earlier CDSCO MD Online portal is not used anymore for fresh submissions, so don’t rely on that.  

In general, the CDSCO manufacturing test license stays valid for 3 years, and you can keep it running by paying the retention fee on time.  

Most cases see approval in about 2–4 months, but it can shift based on how complete the documents are, and also on how fast the queries get answered. 

What Is the CDSCO Manufacturing Test License?

The CDSCO manufacturing test license lets a manufacturer produce small quantities of a medical device (Class A, B, C, or D) purely for clinical investigation, testing, evaluation, demonstration, or training — before commercial sale. The manufacturer applies online through Form MD-12 on the NSWS portal, attaches the required device and facility documents, and pays the prescribed government fee. After document verification, the Central Drugs Standard Control Organisation (CDSCO), the Central Licensing Authority, issues the approval as Form MD-13. This MD-13 test license is typically valid for 3 years and is a mandatory step before applying for a full commercial manufacturing license under the Medical Device Rules, 2017.

What Is CDSCO, and Why Is the Test License Required?

CDSCO (Central Drugs Standard Control Organisation) is India's national regulatory authority for drugs and medical devices, functioning as the Central Licensing Authority under the Medical Device Rules, 2017. Before any new medical device can be manufactured commercially, the manufacturer must first prove the device works safely under controlled conditions. The MD-12/MD-13 test license route exists for exactly this purpose — it allows limited-batch production for trials and evaluation, without requiring a full commercial license upfront

Benefits of the CDSCO MD-13 Test License

Allows legal small-batch manufacturing for clinical investigation and performance evaluation.

Generates real-world performance data needed for the full manufacturing license application.

Helps validate quality management systems and facility readiness before scaling up.

Builds regulatory credibility with CDSCO ahead of commercial license applications.

Mandatory prerequisite for Class A, B, C, and D device manufacturers seeking commercial approval.

Eligibility Criteria for MD-12 Application

Any individual or company intending to manufacture a medical device in India for non-commercial purposes — testing, clinical investigation, demonstration, evaluation, or staff training — is eligible to apply. The applicant must have:

A registered manufacturing premises with the equipment and instruments needed for the specific device.

Qualified technical personnel responsible for manufacturing and quality testing.

A valid NSWS portal account and Sugam portal registration.

A clearly defined non-commercial purpose stated in an undertaking.

Step-by-Step MD-12 to MD-13 Registration Process

Create an account on the NSWS portal (nsws.gov.in) and complete Sugam portal registration.

Classify the medical device under Class A, B, C, or D as per the Medical Fill the online Form MD-12 with device details, intended use, manufacturing purpose, and facility information.

Upload all supporting documents as per the official MD-12 checklist.

Pay the applicable government fee through the portal.

Submit the application for review by the Central Licensing Authority.

Respond to any queries or deficiency letters raised by CDSCO.

On satisfactory review, CDSCO grants the test license as Form MD-13.

Documents Required for MD-12 Application

Covering letter stating the objective of the test license.

Brief description of the medical device — intended use, materials, and design.

Undertaking to confirm the availability of equipment, instruments, and personnel.

List of manufacturing and testing equipment.

List of qualified technical and quality personnel with credentials.

Device Master File and Plant/Site Master File.

Evidence of quality management system implementation.

CDSCO MD-12/MD-13 Fees and Validity

Application Form: MD-12 (Filed online through the NSWS Portal)

License Granted As: MD-13 (Issued by CDSCO / Central Licensing Authority)

Government Fee: As prescribed under the Medical Device Rules, 2017

Fee Details: Refer to the latest NSWS/CDSCO checklist for current applicable fees

Validity: 3 years from the date of issuance

Retention Requirement: License validity is maintained through timely payment of retention fees

Processing Time: Approximately 2–4 months

Approval Timeline Depends On: Completeness and accuracy of submitted documents and regulatory review process.

Renewal and License Retention

The MD-13 test license does not get a new expiry date on renewal. Instead, manufacturers maintain their validity by paying the prescribed retention fee through the NSWS portal before the 3-year period lapses, along with updated Device Master File, Plant Master File, and quality management system records. Failure to pay the retention fee or submit updated documents on time can lead to suspension of the license.

From Test License to Commercial Manufacturing License

Once trial data, performance evaluation results, and quality records are ready, manufacturers move to the commercial stage. Class A and B devices apply via Form MD-3 for a license granted as Form MD-5, while Class C and D devices apply via Form MD-7 for a license granted as Form MD-9. The MD-12/MD-13 test license is the foundation that makes this next step possible — CDSCO expects evidence from test manufacturing before granting full commercial authorisation.

Conclusion

Securing a CDSCO manufacturing license through the MD-12 application and MD-13 grant process is a critical regulatory milestone for any medical device manufacturer in India. Understanding device classification, document requirements, fees, and timelines helps manufacturers plan effectively and stay compliant under MDR 2017. For the most accurate and updated requirements, always refer to the official CDSCO and SUGAM portal guidelines.

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

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CDSCO Registration for Medical Devices — Fast, Reliable & Hassle-Free

Getting CDSCO Registration for your medical device doesn't have to be complicated. At Silvereye Certifications, we handle everything — from documentation to final approval. Manufacturers and importers across India trust us for smooth, reliable CDSCO Certification support. We know the process inside out, and we make sure you do too.

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CDSCO Import Test License Registration: MD-16 & MD-17 Complete Guide (2026)

MD-16 is the official application document used to obtain a CDSCO Import Test License for medical devices as well as IVDs in India.  

MD-17 is the official Grant of License that CDSCO issues after they finish reviewing the MD-16 submission under the MDR 2017.  

This license is required for any overseas manufacturer or Indian importer who brings in medical devices for testing, trial runs, or evaluation purposes.  

The whole workflow is handled online via the SUGAM portal, so in 2026 it tends to be quicker, more transparent and easier to follow, step by step. 

What is the CDSCO Import Test License Registration?

CDSCO Import Test License Registration is the regulatory process under which importers apply using Form MD-16 to bring medical devices or in-vitro diagnostics into India for testing or evaluation. Once CDSCO reviews and approves the MD-16 application, it issues Form MD-17 — the official Grant of License. This license is mandatory under the Medical Devices Rules (MDR), 2017 and is governed by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, Government of India.

What Is CDSCO Import Test License? (MD-16 & MD-17 Explained)

India's medical device import regulatory framework is governed by the Medical Devices Rules (MDR), 2017. Under this framework, any party wishing to import a medical device or IVD (In-Vitro Diagnostic) solely for testing, evaluation, or research purposes — and not for commercial sale — must obtain a specific license from CDSCO.

Form MD-16 is the application submitted to CDSCO requesting this import test license. Upon successful verification, CDSCO issues Form MD-17, which is the Grant of License confirming legal permission to import the device for test purposes.

CDSCO Import Test License Forms

Form MD-16

Purpose: Application for Import Test License

Issued By: Submitted by the applicant to CDSCO for approval

Form MD-17

Purpose: Grant of Import Test License

Issued By: Issued by CDSCO to the applicant upon approval of the application

Why Is CDSCO Import Test License Registration Important?

 If you don’t have the CDSCO Import Test License, also called the MD-17, then bringing in a medical device— even if it’s only for internal assessment— can become a regulatory issue under MDR 2017. And yeah, that can happen even when the intention is not commercial. Here’s the point, for importers and manufacturers alike:

It helps ensure compliance with Indian regulatory standards before any real commercial-type import happens.  

It permits clinical observation or lab testing of newer devices without doing a full-scale import registration.  

It protects the company from legal penalties and even the risk of device retention or seizure at customs.  

It builds long-term credibility with CDSCO, which makes later commercial import license applications easier.  

It becomes necessary when multi-country trials include Indian test locations or CRO support, where devices need to come in for study work. 

Who Needs a CDSCO Import Test License? — Eligibility Criteria

The following entities are eligible to apply for the CDSCO Import Test License via Form MD-16:

Foreign Manufacturer

Eligibility Condition: Must appoint a registered Indian Authorised Representative (AR) or importer.

Indian Importer / Distributor

Eligibility Condition: Must be a legally registered entity in India with a valid business address.

Research Institution / Hospital

Eligibility Condition: Can apply for importing medical devices required for clinical evaluation, research, or trials.

Contract Research Organisation (CRO)

Eligibility Condition: Eligible when the device import is exclusively for study, research, or clinical trial purposes.

Start-up / Medical Device Company

Eligibility Condition: Eligible if the import is restricted to research & development (R&D), prototype testing, product evaluation, or demonstration purposes.

Key eligibility point: The device must not be intended for commercial sale in India at the time of import. The license is strictly for testing, evaluation, or research use.

Documents Required for CDSCO Import Test License (MD-16 Application)

Preparing the right documents is critical for smooth MD-16 approval. Below is the complete checklist for 2026:

Duly Filled Form MD-16

Details: Online application submitted through the SUGAM Portal.

Device Description & Specifications

Details: Technical specifications, intended use, indications, and model numbers of the device.

Certificate of Registration / Incorporation

Details: Proof of business registration of the Indian applicant entity.

Authorization Letter from Foreign Manufacturer

Details: Required when applying on behalf of a foreign OEM (Original Equipment Manufacturer).

ISO 13485 Certificate (if available)

Details: Quality Management System (QMS) certification for medical devices.

CE Mark / FDA Clearance (if applicable)

Details: Regulatory approval obtained from the country of origin.

Free Sale Certificate (FSC)

Details: Certificate issued by the competent authority in the country of origin confirming the legal sale of the product.

List of Ingredients / Composition

Details: Required for IVDs and certain Class B, C, and D medical devices.

Purpose of Import Declaration

Details: A declaration letter clearly stating the purpose of import for testing, evaluation, research, or demonstration.

Previous Approval Letter (for Renewal Applications)

Details: Existing MD-17 approval/license copy required for renewal applications.

Step-by-Step CDSCO Import Test License Application Process (2026)

The application process for CDSCO Import Test License registration is fully online via the SUGAM portal (sugamapplication.gov.in). Follow these steps:

Register on the SUGAM Portal — Create an account as an importer or authorised agent. Verify your email and set up your profile with company details.

Prepare All Documents — Gather all required documents (see checklist above) in PDF format. Ensure all certificates are current and notarised

Fill Form MD-16 Online — Navigate to 'Medical Device Import' and select 'Application for Import Test License (MD-16)'. Fill all fields accurately, including device name, class, and import quantity.

Upload Supporting Documents — Attach all documents in the specified file formats. File size limits apply; ensure clarity and readability of scanned documents.

Pay the Application Fee — Pay the prescribed fee online through the SUGAM payment gateway. Keep the payment receipt for records.

Submit & Track Application — Submit the form and note your application tracking number. Track status on the SUGAM portal under 'Application Status'.

CDSCO Review & Query Response — CDSCO officers may raise queries or request additional information. Respond promptly to avoid delays.

Receive MD-17 (Grant of License) — Upon approval, download Form MD-17 from the SUGAM portal. This is your official CDSCO Import Test License.

CDSCO Import Test License Fee Structure (2026)

The fee for CDSCO Import Test License registration depends on the device class and type of application:

New Import Test License (MD-16)

Device Class: Class A / B

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule

New Import Test License (MD-16)

Device Class: Class C / D

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule

Renewal of Import Test License

Device Class: All Classes

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule

Amendment to Existing License

Device Class: All Classes

Approximate Fee: As prescribed under the Medical Devices Rules (MDR), 2017 Schedule.

Important: Fee amounts are prescribed under the Third Schedule of MDR 2017 and are subject to revision by CDSCO. Always check the official SUGAM portal or CDSCO website for the latest fee at the time of application.

Validity & Renewal of CDSCO Import Test License (MD-17)

License Validity

Typically issued for a specific period as approved by CDSCO, commonly ranging from 1 to 3 years.

Renewal Timeline

Renewal application should be submitted at least 30–60 days before the license expiry date through the SUGAM Portal.

Renewal Form

Renewal is generally filed using the same Form MD-16, along with updated supporting documents and a renewal declaration.

Lapse Consequences

Importing medical devices without a valid MD-17 license is considered a regulatory violation under the Medical Devices Rules (MDR), 2017.

Post-Renewal

Upon approval of the renewal application, CDSCO issues a fresh MD-17 Import Test License with updated validity dates.

Key Benefits of Obtaining a CDSCO Import Test License

Full Legal Compliance — Eliminates risk of goods seizure at customs or regulatory action by CDSCO.

Pathway to Commercial Registration — Builds a documented regulatory track record with CDSCO for future full import licenses.

Enables Clinical Trials & Evaluations — Mandatory for devices used in Indian clinical studies or hospital evaluations.

Global Market Entry Strategy — Helps foreign OEMs test market acceptability in India before full commercial launch.

Competitive Advantage — Demonstrates regulatory diligence to Indian hospital partners, distributors, and investors.

SUGAM Integration — Digital license management enables faster renewals and amendments with full audit trails.

Common Mistakes to Avoid in the MD-16 Application

Incomplete Device Description

How to Avoid: Use the full technical device name, detailed specifications, and the appropriate GMDN code wherever applicable.

Expired Supporting Certificates

How to Avoid: Ensure all certificates, such as ISO 13485, CE Certificate, and Free Sale Certificate (FSC), are valid at the time of application submission.

Incorrect Device Classification

How to Avoid: Verify the device classification under Schedule III of the Medical Devices Rules (MDR), 2017, before filing the application.

Delay in Responding to CDSCO Queries

How to Avoid: Regularly monitor the SUGAM Portal and submit responses within the specified timelines.

Mismatch in Manufacturer Details

How to Avoid: Ensure the manufacturer's name, address, and other details are identical across all submitted documents.

Unclear Purpose of Import

How to Avoid: Submit a clear declaration letter specifying the exact purpose of import, such as testing, evaluation, research, clinical study, or demonstration.

MD-16 vs MD-17: Key Differences at a Glance

MD-16

Type

Application Form

Who Files It

Applicant (Importer / Authorized Representative)

Purpose

Request permission to import a medical device for testing, evaluation, demonstration, or clinical investigation

Stage

Pre-approval stage

Contains

Device details

Supporting documents

Application fee details

Validity

Not applicable, as MD-16 is only an application form

MD-17

Type

Grant of License

Who Issues It

Issued by CDSCO

Purpose

Grants legal permission to import a medical device for testing, evaluation, demonstration, or clinical investigation

Stage

Post-approval stage

Contains

License number

Validity period

Terms and conditions of approval

Validity

As specified on the MD-17 license document issued by CDSCO

Related Regulatory Terms & Concepts

Understanding these related terms will help you navigate the CDSCO import licensing process more effectively:

MDR 2017

Meaning: Medical Devices Rules, 2017 — the primary regulatory framework governing medical device imports, manufacturing, and distribution in India.

SUGAM Portal

Meaning: An online government platform used for CDSCO applications related to medical devices, drugs, and cosmetics.

GMDN Code

Meaning: Global Medical Device Nomenclature code used for identifying and classifying medical devices.

Authorised Representative (AR)

Meaning: An Indian entity authorised by a foreign manufacturer to represent them for regulatory submissions and compliance activities in India.

IVD (In-Vitro Diagnostic)

Meaning: A category of medical devices used for testing specimens such as blood, urine, or tissue samples outside the human body.

Free Sale Certificate (FSC)

Meaning: A document confirming that the medical device is legally marketed and sold in its country of origin.

Class A / B / C / D

Meaning: Medical device risk classifications under MDR 2017, ranging from:

Class A – Low Risk

Class B – Low to Moderate Risk

Class C – Moderate to High Risk

Class D – High Risk

CDSCO

Meaning: The Central Drugs Standard Control Organisation, India's national regulatory authority responsible for regulating medical devices, drugs, and cosmetics.

Conclusion: Navigate CDSCO Import Test License Registration with Confidence

CDSCO Import Test License Registration — through Form MD-16 and the resulting MD-17 grant — is a critical regulatory step for anyone importing medical devices or IVDs into India for testing, evaluation, or clinical study. The process is fully digital via the SUGAM portal and has become increasingly streamlined in 2026.

Getting the documentation right, understanding the eligibility criteria, and adhering to CDSCO timelines make the difference between a smooth approval and unnecessary delays. Whether you are a foreign OEM entering the Indian market, a CRO running device trials, or a domestic importer exploring new product categories, a valid MD-17 license protects your business and ensures full regulatory compliance under MDR 2017.

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CDSCO MD-14 Import License for Cardiac Devices: Complete Guide 2026

At a Glance

•        MD-14 is the mandatory CDSCO import license required for all Class C and Class D cardiac medical devices entering India.

•        Application is filed online via the SUGAM portal under the Medical Devices Rules, 2017 (MDR 2017).

•        License validity is 3 years; renewal must be applied for 90 days before expiry to avoid business disruption.

•        Non-compliance with MD-14 requirements can result in an import ban, product recall, and legal penalties under the Drugs Act.

1. What is the CDSCO MD-14 Import License for Cardiac Devices?

The CDSCO MD-14 Import License is a regulatory authorisation granted by the Central Drugs Standard Control Organisation (CDSCO) under India's Ministry of Health & Family Welfare. It is specifically required for importers who wish to import Class C (moderate-to-high risk) and Class D (high risk) medical devices, which include a broad range of cardiac devices.

Under the Medical Devices Rules, 2017 (MDR 2017), no person shall import any notified medical device or in vitro diagnostic device without holding a valid import license issued under Form MD-14. This rule was enforced to ensure patient safety, product quality, and regulatory traceability of all cardiac devices entering the Indian market.

In simple terms, if you are an importer of cardiac medical devices in India, MD-14 is not optional. It is the legal gateway to operating your import business.

2. Complete List of Cardiac Devices Covered Under CDSCO MD-14

The following cardiac devices are classified as notified medical devices under MDR 2017 and require an MD-14 import license. This is the complete list as applicable in 2026:

Coronary Stents (Drug-Eluting & Bare Metal)

Risk Class: Class D

License Required: MD-14

Implantable Cardiac Pacemakers

Risk Class: Class D

License Required: MD-14

Implantable Cardioverter Defibrillators (ICD)

Risk Class: Class D

License Required: MD-14

Cardiac Resynchronisation Therapy (CRT) Devices

Risk Class: Class D

License Required: MD-14

Mechanical & Biological Heart Valves

Risk Class: Class D

License Required: MD-14

Left Ventricular Assist Devices (LVAD)

Risk Class: Class D

License Required: MD-14

Cardiac Catheters

Risk Class: Class C

License Required: MD-14

Balloon Angioplasty Catheters

Risk Class: Class C

License Required: MD-14

Intravascular Ultrasound (IVUS) Catheters

Risk Class: Class C

License Required: MD-14

Leadless Pacemakers

Risk Class: Class D

License Required: MD-14

Subcutaneous ICD (S-ICD)

Risk Class: Class D

License Required: MD-14

Transcatheter Aortic Valve Replacement (TAVR) Devices

Risk Class: Class D

License Required: MD-14

Extracorporeal Membrane Oxygenation (ECMO) Devices

Risk Class: Class D

License Required: MD-14

Peripheral Vascular Stents

Risk Class: Class C/D

License Required: MD-14

Cardiac Ablation Catheters

Risk Class: Class C

License Required: MD-14

Electrophysiology Recording Systems

Risk Class: Class C

License Required: MD-14

Rotational Atherectomy Systems

Risk Class: Class C

License Required: MD-14

Intra-Aortic Balloon Pumps (IABP)

Risk Class: Class D

License Required: MD-14

Cardiac Patch & Repair Products

Risk Class: Class C/D

License Required: MD-14

Cardiac Loop Recorders (Implantable)

Risk Class: Class D

License Required: MD-14

3. Who Needs CDSCO MD-14 Import License?

The MD-14 import license is required by any entity that imports cardiac medical devices into India for commercial purposes. This includes:

•        Indian companies importing cardiac devices from foreign manufacturers for sale or distribution in India.

•         Authorised Indian agents of overseas cardiac device manufacturers.

•        Distributors and wholesalers of cardiac medical devices who also handle import operations.

•        Hospitals and healthcare institutions importing cardiac devices directly for their own use (where applicable under current rules).

It is important to note that the importer must have a registered business entity in India. The foreign manufacturer does not hold the MD-14 license; the Indian importer does.

4. Eligibility Criteria for MD-14 Import License

To be eligible for a CDSCO MD-14 import license for cardiac devices, you must meet the following criteria:

Business Registration

Requirement: Must be a registered company, LLP, partnership firm, or proprietorship in India.

Premises

Requirement: Adequate storage facility complying with Good Distribution Practice (GDP) norms.

Qualified Person

Requirement: A technically qualified person with a diploma or degree in pharmacy, medicine, or an equivalent qualification.

Manufacturer Tie-up

Requirement: Free Sale Certificate (FSC) or Certificate of Pharmaceutical Product (CoPP) issued by the manufacturer's country of origin.

Foreign Manufacturer

Requirement: The manufacturer must hold a valid medical device approval in the country of origin or possess CE Marking/FDA clearance.

Product Registration

Requirement: The specific medical device must be registered or approved by CDSCO under Form MD-15 or MD-16 (for new devices).

5. Documents Required for CDSCO MD-14 Import License

Gathering the right documents is the most critical step. Missing even one document can cause rejection or delays. Here is the complete document checklist for 2026:

A. Company/Applicant Documents

•        Certificate of Incorporation / Registration Certificate of the applicant company

•        GST Registration Certificate

•        Import Export Code (IEC) issued by DGFT

•        PAN Card of the Company

•        Memorandum of Association (MoA) / Articles of Association (AoA)

•        List of Directors / Partners with identification proof

B. Premises Documents

•        Proof of premises ownership or lease agreement

•        Site Master File (SMF) or premises layout plan

•        Temperature and humidity monitoring records (for storage area)

•        Cold chain documentation (if applicable for the device)

C. Qualified Person Documents

•        Educational qualifications of the authorised technical person

•        Appointment letter and ID proof

D. Foreign Manufacturer Documents

•        Free Sale Certificate (FSC) or Certificate to Foreign Government from the country of origin

•        Good Manufacturing Practice (GMP) Certificate of the manufacturer

•        CE Mark Certificate / US FDA 510(k) or PMA clearance / ISO 13485 Certificate

•        Manufacturing License of the foreign manufacturer

•  Authorisation letter appointing the Indian importer as the authorised agent

•        Device Master File (DMF) or Technical Documentation of the cardiac device

E. Product-Specific Documents

•        Product labelling and packaging in English

•        Instruction for Use (IFU) / User Manual in English

•        Biocompatibility test report (as per ISO 10993)

•        Clinical data / clinical evaluation report

•        Performance data and test reports

•    Sterilisation  validation report (if device is sterile)

•        Shelf life and stability data

•        Declaration of Conformity

6. Step-by-Step Process to Apply for CDSCO MD-14 Import License

The application for MD-14 is entirely online via the SUGAM portal (sugamapplication.gov.in). Here is the step-by-step process:

1.     Create an account on the SUGAM portal (sugamapplication.gov.in) as a new applicant.

2.     Log in and select 'Import License' under the Medical Devices module.

3.     Fill in Form MD-14 with complete applicant and product details.

4.     Upload all required documents in PDF format as per the checklist.

5.     Pay the prescribed government fee online through the payment gateway.

6.     Submit the application. An application reference number is generated.

7.     CDSCO technical officer reviews the application and may raise queries.

8.     Respond to queries (if any) within the stipulated time period.

9.     CDSCO may conduct a premises inspection for new applicants.

10.  On approval, the MD-14 license is issued and available for download from SUGAM portal.

7. Government Fees for CDSCO MD-14 Import License (2026)

The government fees for the MD-14 import license are prescribed under the Medical Devices Rules, 2017, Second Schedule. Note: These fees are subject to revision by the government.

Application Fee (New License)

Amount: ₹50,000 per device

Additional Device Fee

Amount: ₹10,000 per additional device (under the same application)

Renewal Fee

Amount: ₹25,000 per device

Amendment Fee

Amount: ₹5,000 per amendment

Late Renewal Penalty

Amount: ₹1,000 per month of delay after the renewal due date

Note: Fees are paid online through the SUGAM portal via NEFT/RTGS or online payment gateway. Keep the payment receipt for records.

8. Validity and Renewal of MD-14 Import License

License Validity: 3 years from the date of grant.

Renewal Deadline: Application must be submitted at least 90 days before expiry.

Grace Period: If a renewal application is filed before expiry, the license continues to remain valid until a decision is made by CDSCO.

Renewal Process: Same SUGAM portal; select 'Renewal' option and submit updated documents along with the renewal fee.

What Happens If Not Renewed?: The license lapses. Importing under a lapsed license is a legal violation attracting penalties, seizure, and prosecution.

Pro Tip: Set a reminder at least 120 days before expiry to begin the renewal documentation process. For cardiac devices, document updates like renewed GMP certificates, updated FSC, and revised product labelling are common renewal requirements.

9. Processing Timeline for MD-14 Import License

Document Preparation

Estimated Timeline: 2 to 4 weeks

SUGAM Portal Submission

Estimated Timeline: 1 to 2 days

Initial CDSCO Review

Estimated Timeline: 30 to 45 days

Query Response & Resubmission

Estimated Timeline: 15 to 30 days (if CDSCO raises queries)

Premises Inspection (if required)

Estimated Timeline: 30 to 60 days

Final Approval & License Issuance

Estimated Timeline: 15 to 30 days after inspection or regulatory clearance

Total Estimated Timeline

90 to 180 days (approximately 3 to 6 months) for complete license approval and issuance.

Timeline may vary depending on CDSCO workload, completeness of documents, and whether an inspection is required. Applications with complete and correct documentation are processed faster.

10. Key Compliance Requirements After Obtaining MD-14

Holding an MD-14 license comes with ongoing compliance obligations. As a licensed importer of cardiac devices, you must:

•        Maintain records of all import transactions, including quantity, batch numbers, and distribution records, for a minimum of 5 years.

•        Ensure product labelling meets CDSCO requirements, including Unique Device Identification (UDI) as mandated.

•        Report any adverse events or field safety corrective actions (FSCA) to CDSCO promptly.

•        Conduct periodic quality checks and maintain storage conditions as prescribed.

•        Submit annual returns to CDSCO through the SUGAM portal.

•        Inform CDSCO of any change in premises, qualified person, or product details through amendment applications.

•        Cooperate with CDSCO inspectors during routine or surprise inspections.

11. Common Reasons for MD-14 Application Rejection or Delay

•        Incomplete or incorrectly filled Form MD-14 on the SUGAM portal.

•        Free Sale Certificate (FSC) not apostilled or notarised as required.

•        GMP certificate or CE certificate expired at the time of application.

•     Authorisation letter from manufacturer not on company letterhead or lacking notarization.

•        Premises not meeting GDP storage standards during inspection.

•        Clinical data or biocompatibility reports not in the required format.

•        Non-response or delayed response to CDSCO queries.

About This Guide

This pillar page has been authored by regulatory compliance professionals with hands-on experience in CDSCO medical device licensing. The information is based on the Medical Devices Rules, 2017 (MDR 2017), official CDSCO guidelines, and SUGAM portal procedures as updated in 2026.

Always verify the latest fee schedule, document requirements, and procedural updates directly on the official CDSCO website (cdsco.gov.in) and SUGAM portal (sugamapplication.gov.in) before making your application, as regulations may change.

For specific regulatory advisory, consult a licensed regulatory affairs consultant or legal professional experienced in Indian medical device law.

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Cosmetic Import License in India: COS-1 & COS-2 Certificate Guide for Importers (2026)

Mandatory CDSCO registration is required before importing any cosmetic product into India

Two separate certificates apply: COS-1 for new cosmetic imports, COS-2 for already registered products

Government fee starts from INR 3,000 per product; validity is 3 years with a renewal option

Online application via the SUGAM portal with a 45–90 day processing timeline

What is a Cosmetic Import License?

A Cosmetic Import License for India is a required go-ahead that is issued by CDSCO (Central Drugs Standard Control Organisation) under the Drugs & Cosmetics Act, 1940. Basically, if any individual or firm plans to bring cosmetics into India, they have to secure either a COS-1 certificate for new product registration, or a COS-2 certificate for renewal, or for further import of cosmetics that are already registered. The whole point of this permission is to make sure the imported cosmetics satisfy India's safety rules, labelling expectations, and quality measures before these items actually reach end consumers.

1. What is a Cosmetic Import License in India?

Importing cosmetics into India without proper registration is illegal. The Drugs & Cosmetics Act, 1940, along with the Cosmetics Rules, 2020, governs the import of cosmetic products. CDSCO, under the Ministry of Health & Family Welfare, is the nodal regulatory authority that evaluates and grants cosmetic import registrations.

Whether you are a startup importing skincare products or an established brand bringing in haircare or makeup lines, you must complete the cosmetic import registration process before your shipment clears Indian customs.

Which Cosmetic Products Require Import Registration?

Under Schedule M-II and the Cosmetics Rules, 2020, the following product categories must be registered:

Skin care products (moisturisers, serums, sunscreens, face washes)

Hair care products (shampoos, conditioners, hair oils, hair dyes)

Makeup and colour cosmetics (foundations, lipsticks, mascaras)

Nail products and nail enamels

Perfumes, deodorants, and antiperspirants

Baby care, cosmetics and personal hygiene products

Oral hygiene products (toothpaste, mouthwash)

Shaving products and aftershave lotions

2. COS-1 vs COS-2 Certificate: Key Differences Explained

There are two types of cosmetic import certificates issued by CDSCO. Understanding which one applies to your situation is the first step in the application process.

COS-1 Certificate

Purpose

New cosmetic product registration for import

Applicant

First-time importer of a specific cosmetic product

Validity

3 Years

Government Fee

₹3,000 per product

Processing Time

60–90 working days

Free Sale Certificate (FSC)

Required from the country of origin

Product Samples

May be required by CDSCO

COS-2 Certificate

Purpose

Re-registration or additional importer for an already registered cosmetic product

Applicant

Subsequent importer or renewal applicant

Validity

3 Years

Government Fee

₹1,500 per product

Processing Time

30–45 working days

Free Sale Certificate (FSC)

Required from the country of origin

Product Samples

Usually not required by CDSCO

3. Who Can Apply for a Cosmetic Import License?

CDSCO grants cosmetic import registration to legally registered Indian entities or authorised representatives. The following are eligible to apply:

Private limited or public limited companies registered in India

Sole proprietors and partnership firms with valid business registration

LLPs (Limited Liability Partnerships) with Indian registration

 Authorised Indian agents of foreign cosmetic manufacturers

Existing importers seeking renewal of expired licenses

Important: Foreign manufacturers cannot apply directly. They must appoint an authorised Indian importer or agent who holds a valid Indian business registration to apply on their behalf.

4. Documents Required for Cosmetic Import Registration

Submitting a complete document set is critical to avoid delays or rejection. Below is a detailed checklist for both COS-1 and COS-2 applications.

Mandatory Documents for All Applicants

Application Form 42 duly filled and signed

Copy of business registration certificate (Certificate of Incorporation / Partnership Deed / MSME Certificate)

PAN card of the applicant firm or company

GST registration certificate (active and valid)

IEC (Import Export Code) issued by DGFT

Undertaking on company letterhead confirming compliance with Cosmetics Rules, 2020

Product-Specific Documents

Certificate of Free Sale (CFS) issued by the competent authority of the country of origin

Certificate of Manufacturing and Analysis (CoA) for each product

Complete list of ingredients (INCI names) and their percentage composition

Product labels in the format complying with Indian labelling requirements

Product samples (when requested by CDSCO)

Manufacturing site details and the GMP certificate of the overseas manufacturer

Stability data and shelf life details of the product

Safety data or toxicological data (for certain product categories)

For COS-2 (Re-registration / Additional Importer)

Copy of original COS-1 registration certificate

Authorisation letter from the registered brand owner or original manufacturer

No-objection certificate (NOC) from the existing registered importer (if applicable)

5. Step-by-Step Cosmetic Import License Process in India

The entire cosmetic import registration process is handled online through the SUGAM portal (sugam.gov.in), managed by CDSCO. Here is the complete step-by-step process:

Create an account on the SUGAM Portal (sugam.gov.in) using your business email ID and valid mobile number.

Complete the applicant profile by uploading your firm’s basic documents — IEC, GST, and business registration.

Select the application type: COS-1 for new product registration or COS-2 for re-registration.

Fill in product details, including product name, category, brand name, manufacturer details, ingredients, and country of origin.

Upload all required documents in the prescribed format (PDF/JPEG; file size limit applies per field).

Pay the applicable government fee online via the SUGAM payment gateway (Net Banking / Debit Card / Credit Card / UPI).

Submit the application and note the Application Reference Number (ARN) for future tracking.

CDSCO technical officer reviews the application; a deficiency letter may be raised requiring additional documents within 30 days.

Reply to any deficiencies promptly through the SUGAM portal. Delayed replies can result in rejection.

CDSCO grants approval, and the COS-1 or COS-2 certificate is digitally issued and downloadable from the portal.

Pro Tip: Ensure all uploaded documents are notarised and apostilled (for foreign documents) before uploading. Documents in languages other than English must be accompanied by a certified English translation.

6. Cosmetic Import License Fees in India (2026)

Fees are payable online via the SUGAM portal at the time of application submission. Below is the current fee structure:

COS-1 – New Product Registration

Application Type

New Product Registration

Government Fee

₹3,000 per product

Validity

3 Years

COS-2 – Re-registration / Additional Importer

Application Type

Re-registration or Additional Importer Registration

Government Fee

₹1,500 per product

Validity

3 Years

COS-1 – Renewal

Application Type

Renewal before expiry

Government Fee

₹3,000 per product

Validity

3 Years

Late Renewal Fee

Application Type

Renewal after expiry (penalty applicable)

Government Fee

₹3,000 per product + applicable penalty

Validity

3 Years

Note: The above fees are government (statutory) fees only. Professional or consultancy charges for assistance with registration are separate and vary by service provider.

7. Validity and Renewal of Cosmetic Import License

Both COS-1 and COS-2 certificates are valid for 3 years from the date of grant. Importers must renew before expiry to avoid disruptions in their import operations.

Renewal Timeline and Key Points

Apply for renewal at least 60 days before the certificate expiry date

Renewal application follows the same SUGAM portal process as the original application

If the certificate lapses, a fresh COS-1 application (not a renewal) may be required

Late renewal may attract a penalty in addition to the regular renewal fee

Product formulation, labelling, and manufacturer details must remain unchanged; any change requires fresh registration

8. Benefits of Obtaining a Cosmetic Import License

Securing your cosmetic import registration is not just a legal requirement — it offers several business and operational advantages:

Legal compliance: Eliminates risk of product seizure, legal action, or import ban at Indian ports

Market access: Required for listing products on Indian e-commerce platforms (Amazon, Flipkart, Nykaa) and in retail chains

Consumer trust: Registered cosmetics carry CDSCO approval, building buyer confidence

Brand protection: Official registration prevents unauthorised parallel imports of your brand

Customs clearance: Simplifies Bill of Entry processing with a valid CDSCO registration number

Business scalability: Enables tie-ups with large Indian distributors and retail chains that mandatorily verify registration

9. Common Reasons for Rejection or Delay

Understanding common pitfalls can help you avoid costly delays in your cosmetic import registration:

Incomplete or incorrect ingredient list (missing INCI names or percentages).

CFS certificate has expired or was not issued by a recognised competent authority

Labels do not comply with Indian labelling rules (missing mandatory fields like country of origin, net content, best-before date)

GMP certificate of the manufacturer is not valid or not apostilled

No reply to the CDSCO deficiency letter within the stipulated time

Mismatch between the product name on the label and the product name in the application form

Safety data not provided for products containing prohibited or restricted ingredients

10. Labelling Requirements for Imported Cosmetics in India

Every imported cosmetic must comply with the labelling standards under Rule 131 of the Cosmetics Rules, 2020. The label must display:

Name and address of the manufacturer (overseas) and importer (India)

Net content by weight or volume

List of ingredients in INCI nomenclature

Best-before date or shelf life (in Month/Year format)

Batch number or lot number for traceability

Country of manufacture (e.g., Made in France)

CDSCO registration number (COS-1 or COS-2 number)

Any required warnings or directions for use

11. SUGAM Portal: Online Application Platform

CDSCO’s SUGAM portal (sugam.gov.in) is the single online window for all cosmetic import-related applications. Key features include:

24x7 online application submission

Real-time application status tracking

Online fee payment integration

Digital certificate issuance (downloadable and verifiable)

Deficient communication and reply module

Application history and archive for renewal reference

Cosmetic Import License India 2026

Governing Authority

CDSCO (Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare

Governing Law

Drugs & Cosmetics Act, 1940

Cosmetics Rules, 2020

Certificate Types

COS-1 (New Registration)

COS-2 (Re-registration / Additional Importer)

Application Portal

SUGAM Portal (sugam.gov.in)

Eligibility

Registered Indian companies

Partnership firms

LLPs (Limited Liability Partnerships)

Authorised agents of foreign manufacturers

Fee for COS-1

₹3,000 per product

Fee for COS-2

₹1,500 per product

Validity

3 Years (for both COS-1 and COS-2 certificates)

Processing Time

COS-1: 60–90 days

COS-2: 30–45 days

Renewal Requirement

Apply at least 60 days before expiry through the SUGAM Portal

Key Document Required

Certificate of Free Sale (CFS) issued by the country of origin

Need Help with Cosmetic Import License Registration?

Navigating CDSCO’s cosmetic import registration process can be complex, especially for first-time importers managing foreign manufacturer documentation, SUGAM portal technicalities, and compliance with Indian labelling rules simultaneously.

Working with a CDSCO-experienced regulatory consultant helps reduce rejection risk, cut down processing time, and ensure your products reach the Indian market faster. Always verify consultant credentials and check their track record with similar cosmetic import license applications.

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Planning to import, manufacture, or sell medical devices and cosmetics in India? CDSCO Registration is a mandatory regulatory requirement issued by the Central Drugs Standard Control Organisation (CDSCO). It ensures that products meet the safety, quality, and performance standards prescribed under Indian regulations.

In this complete 2026 guide, learn everything about the CDSCO registration process, applicable government fees, required documents, eligibility criteria, approval timelines, and compliance requirements for medical devices and cosmetic products. We cover product classification, SUGAM portal application filing, technical documentation, import registration, manufacturing licenses, and common reasons for application delays or rejection.

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