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IVD Classification System: 2018
In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017.
IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in human beings or animals covered under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and IVDs that are notified, from…
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Recent Important Notifications by CDSCO, SUGAM Updates new draft online - abishek
Recent Important Notifications by CDSCO, SUGAM Updates new draft online – abishek
The Government of India is planning to develop an in-depth regulatory framework for medical devices and IVDs registration. These are regulated under the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of Health and Family welfare of India.
The regulatory structure for medical devices in India is under the Drugs and Cosmetic Act of 1940,…
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Medical Devices Rules, 2017: Classification of Medical Devices Old Backup Abishek
Medical Devices Rules, 2017: Classification of Medical Devices Old Backup Abishek
In India, medical devices are regulated by CDSCO under the control of Drug Controller General of India (DCGI). All medical devices in India is following a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic Act (1940) and Drugs and Cosmetic Rules (1945).
The Health Ministry of India has published new medical device and IVD regulations to replace the country’s…
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Medical Devices Rules, 2017: Classification of IVD’s
Medical Devices Rules, 2017: Classification of IVD’s
On 1st January 2017, India’s Ministry of Health and Family Welfare released the” Medical Device Rules, 2017”, which will come into force January 1, 2018. This regulation will replace the country’s Drugs and Cosmetics Act for creating effective regulation.
As per the guidelines, in vitro diagnostic (IVD’s) used for diagnosis are classified based on their level of risk as follows:
Class A (low risk)
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Medical Devices Rules, 2017: Classification of Medical Devices
Medical Devices Rules, 2017: Classification of Medical Devices
In India, medical devices are regulated by CDSCO under the control of Drug Controller General of India (DCGI). All medical devices in India is following a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic Act (1940) and Drugs and Cosmetic Rules (1945).
The Health Ministry of India has published new medical deviceand IVD regulations to replace the country’s…
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Indian Govt Notifies New Norms to Regulate Medical Devices
Indian Govt Notifies New Norms to Regulate Medical Devices
On February 2, 2017 The Ministry of Health and Family Welfare has announced Medical Devices Rules, 2017 that separates regulatory norms for manufacturing medical devices from drugs. The rules will come into effect from January 1, 2018.
This new rules is to regulate medical devicesin the country to ease norms for manufacturing medical devices in the country and to promote domestic industry. The…
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IVD Classification System: Medical Device Rules, 2016
IVD Classification System: Medical Device Rules, 2016
The Indian Ministry of Health and Family Welfare published a draft of Medical Device Rules, 2016 which are classified medium to high risk IVD devices under the new ivd classification system will require CDSCO (Central Drugs Standard Control Organization) registration certificate or license.
The current regulations has only 23 types of medical devices and IVD require registration and so this…
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Maharashtra FDA Asks Blood Banks to Submit License Renewal Applications
Maharashtra FDA Asks Blood Banks to Submit License Renewal Applications
Maharashtra Food and Drug Administration (FDA) has directed all 306 blood banks in the state to submit applications of renewal of licenses by 31st December 2016 to carry out timely inspections and approvals. There are around 53 blood banks in the state for which renewals are pending.
As stated in Drugs and Cosmetics Rules, 1945 blood bank licenses are valid for 5 years. Central Licensing…
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Indian Syringe and Needle Market 2015-2020
Indian Syringe and Needle Market 2015-2020
Indian syringes and needles market is expected to grow at a CAGR of 15% by 2020. This growth is mainly because of India’s large pool of patients, increase in healthcare expenditure, increase in healthcare awareness and rising government spending.
Syringes and needles market in India is dominated by imported products including products produced by imported material which comprises approximately…
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FSSAI Drafts Safety Regulations for Nutraceuticals & Food Supplements
FSSAI Drafts Safety Regulations for Nutraceuticals & Food Supplements
The Ministry of Health’s Food Safety Standards Authority of India has come out with quality and safety standards to regulate the standards and quality of health supplements, nutraceuticals, food (special dietary care, medicinal purpose, functional food and novel foods) and has sought public comments on the same. The effective date for the new rules is November 24.
Dr DBA Narayana, a leading…
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Forms and Purposes: The Medical Device Rules, 2016
Forms and Purposes: The Medical Device Rules, 2016
The Indian Ministry of Health issued a set of new guidelines on 17 October, 2016 called “The Medical Device Rules, 2016” to define and regulate medical devices as a separate category. This move is to develop an in-depth regulatory framework for medical devices. The new guidelines will make medical device regulations stringent for both manufacturing and importation of medical devices.
The Medical…
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FSSAI Proposes New Rules for Health Supplement misabelling
FSSAI Proposes New Rules for Health Supplement misabelling
On Monday, Indian food safety watchdog the Food Safety and Standards Authority of India (FSSAI) announced that health supplements cannot be sold as medicines at all and also fixed the permissible limits of various ingredients used in the products. New standards have been issued for manufacturers of the products to check mislabelling.
The Food Safety and Standards Authority of India has…
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CDSCO Sugam Portal Benefits and Limitations
CDSCO Sugam Portal Benefits and Limitations
An online licensing portal of the Central Drugs Standard Control Organization (CDSCO) called “SUGAM” had been launched on last year (14 November, 2015) to file application, submission, processing and Grant permission of registration, import license in a fast and reliable delivery of services.
The following are the Benefits and Limitations of “SUGAM – online portal”
Benefits in SUGAM online portal
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More Than Half of Women Plan to Buy Natural Beauty Products
More Than Half of Women Plan to Buy Natural Beauty Products
Now a new survey shows that, natural products continue to remain top of mind for many women when it comes to the personal care beauty products.
The second annual Green Beauty Barometer survey questioned more than 1,000 U.S. women aged 18 and up about their beauty consumer habits and desires including: skin care; hair care; makeup; sunscreen; fragrance and nail care. Among the notable findings are:
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Korean Entrepreneurs to Venture into Indian Cosmetics Market
Korean Entrepreneurs to Venture into Indian Cosmetics Market
The United States remains the biggest market for Korean cosmetic products and nowadays Korean investors are venturing into Indian cosmetic market. The Korea Trade Investment Promotion Agency (KOTRA) launched at least 10 Korean cosmetics brands in India very recent.
There are over 200 brands of Korean cosmetics. The US and China are using this popular brands and the Indian market has not been…
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Medical Device Rules, 2016 - Explanation of Classification System
Medical Device Rules, 2016 – Explanation of Classification System
In an attempt to give our viewers a more detailed explanation of the CDSCO classification systems of the New Medical Device Rules in India, Morulaa HealthTech is publishing their second article on the proposed medical device rules, 2016. The first article covered 15 key points of the new regulatory medical device rules of CDSCO titled as – Regulatory Updates India: New Medical Device Draft Rules,…
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Meet Us at The Medical Device Regulatory Summit in Mumbai
Meet Us at The Medical Device Regulatory Summit in Mumbai
The first Medical Device Regulatory Summit in India is being held at Holiday Inn Mumbai International Airport on 29 November 2016. Morulaa HealthTech is pleased to partner at this event.
Medical Device Regulatory Summit 2016, is an event intended to raise awareness of the need for clarity on regulations, Intellectual properties and export & import guidelines for the Indian Market. The salient…
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