LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA

LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA
MnA Chambers
1 | 12
APPENDIX A
LEGAL PROVISIONS
1. Legal & Regulatory Regime of Indian Medical Device Sector:
1.1 The Drugs and Cosmetics Act, 1940, (“DCA”), together with Rules framed thereunder, viz. Drugs and Cosmetics Rules, 1945 (“D&C Rules”) and the Medical Devices Rules, 2017 (“MDR”) regulates the Indian medical device sector, by governing their authorization, import, manufacture, distribution and sale in India.
1.2 The MDR classifies medical devices into four classes as Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk) and Class D (high risk).
1.3 Each manufacturing location requires a separate license for each Notified Medical Device. The license for manufacturing a Class A or Class B device is issued by the State Licensing Authority whereas the licensing to manufacture a Class C or Class D device is issued by the Central Licensing Authority. Importing a Notified Medical Device into India requires additional legal formalities, including under the provisions of the Export and Import Policy of India.
1.4 The MDR regulates only certain categories of medical devices specifically notified for regulation by the Ministry of Health and Family Welfare. At the time of enactment of the MDR, only 15 categories of medical devices were regulated under those rules. 14 additional medical devices were notified and included within the regulatory framework in 2018 and 2019 with effect from different points of time in 2019, 2020 and 2021.

Recent Amendments:
1.5 On 11th February, 2020, the Government of India gazetted two Notifications, whereby (a) vide S.O. 648(E), in pursuance of Section 3(b)(iv) of DCA, a new definition of medical devices was incorporated and (b) vide G.S.R. 102 (E), the Medical Devices (Amendment) Rules, 2020 were issued.
1.6 By virtue of the above S.O. 648(E) issued by the Ministry of Health and Family Welfare, which came into force on 1st April 2020, all medical devices were effectively brought within the scope of the MDR (“Definition Notification”).
Rather than notifying each individual medical device, the Definition Notification includes an expansive and catch-all definition of medical devices.

DOWNLOAD FULL ARTICLE

Leave a Reply

Your email address will not be published.

Terms and Conditions | Disclaimer

USER’S ACKNOWLEDGEMENT AND REQUEST TO CONTINUE FOR COMPLIANCE WITH INDIAN REGULATIONS

By proceeding further and clicking on the “OK” button hereinbelow, I/we acknowledge that I/we of my/our own accord wish to know more about MnA Chambers (MnA) for my/our own information and use. I/We further acknowledge that there has been no solicitation, invitation or inducement of any sort whatsoever from MnA or any of its members to create a Lawyer-Client relationship through this website. I/We further acknowledge having read and understood the Disclaimer below.

DISCLAIMER

This website is a resource for informational purposes only and is intended, but not promised or guaranteed, to be correct, complete, and up-to-date. All information, publications and legal commentary provided on this website is for illustrative purposes only and should not be regarded or relied upon as legal advice. MnA does not warrant that the information contained on this website is accurate or complete, and hereby disclaims any and all liability to any person for any loss or damage caused by errors or omissions, whether such errors or omissions result from negligence, accident or any other cause. Any reliance on this information is solely at the user’s own risk. Specific legal advice should always be obtained before acting upon any information or commentary provided on the site.

This website is not intended to be a source of advertising or solicitation. By visiting this website, you acknowledge that you are doing so voluntarily of your own free will. You should not consider this information to be an invitation for a lawyer-client relationship. Transmission, receipt or use of this site does not constitute or create a lawyer-client relationship.

This website is not intended to be a source of advertising or solicitation and the contents of the website should not be construed as legal advice. The reader should not consider this information to be an invitation for a lawyer-client relationship and should not rely on information provided herein and should always seek the advice of competent counsel licensed to practice in the reader’s country/state. Transmission, receipt or use of this website does not constitute or create a lawyer-client relationship. No recipients of content from this website should act, or refrain from acting, based upon any or all of the contents of this website.

Furthermore, the owner of this website does not wish to represent anyone desiring representation based solely upon viewing this website or in a country/state where this website fails to comply with all laws and ethical rules of that country/state. Finally, the reader is warned that the use of Internet e-mail for confidential or sensitive information is susceptible to risks of lack of confidentiality associated with sending email over the Internet.