Draft the Medical Devices (Amendment) Rules, 2021

Oct 13, 2021 | by Avantis RegTech Legal Research Team

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Industry Specific Compliance

The Ministry of Health and Family Welfare (MoHFW) on October 12, 2021 has issued Draft the Medical Devices (Amendment) Rules, 2021 to further amend the Medical Devices Rules, 2017. 

The amendment in the Medical Devices Rules, 2017 are as follows: -

• In Rule 19B (2) (iii) & 19D (2) (iii) which specifies “Central medical device testing laboratory”, the following proviso has been inserted, namely: -

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes”. 

The Objections & Suggestions said draft rules shall be taken into consideration on or after the expiry of a period of seven days from October 12, 2021 which may be addressed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at [email protected]

[Notification No- G.S.R. 729(E)]

 


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