Ministry of Health and Family Welfare has published the amended rules vide Notification G.S.R 918(E) dated 31 Dec 2021, to defer the implementation date of Unique device identification (UDI) requirements for medical devices. Implementation date of UDI requirement was 1st Jan 2022 in previous version of Rule 46 of India Medical Devices Rules, 2017. Notification G.S.R 918(E) substituted Rule 46 with the following:
“46. Unique device identification of medical device — With effect from such date as the Central Government may, by order specify, every medical device approved for manufacture for sale or distribution or import, shall bear a unique device identification in the manner as may be specified in such order.”
Comparison of amended and previous UDI Rule 46:
In this regard, draft rules were published by Government in S.O. 877E on 23 Dec 2021 inviting comments or suggestions from all stakeholders on draft within 5 days from the date of notification. After considering suggestions received from the public on the said draft rules, final amended rules are now published vide G.S.R 918(E) on 31 Dec 2021.
Contact us at info@innoreg.in in case you want to discuss how amended rules impact your product portfolio.
References:
1. https://egazette.nic.in/WriteReadData/2021/232284.pdf accessed on 03 Jan 2022
2. https://egazette.nic.in/WriteReadData/2021/232079.pdf accessed on 03 Jan 2022
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