The Ministry of Health and Family welfare notifies the draft Medical Devices (Amendment) Rules, 2021 vide notification dated December 23, 2021, to further amend Medical Device Rules, 2017.

The draft amendment amends the Medical Devices Rules, 2017- for rule 46, the following rule shall be substituted:


“46. Unique device identification of the medical device — With effect from the date as may be specified by Central Government, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification in the manner as may be determined.”


It has been notified that the said draft rules shall be taken into consideration on or after the expiry of a period of five days from the date on which copies of the Gazette of India containing these draft rules are made available to public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, 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


*Tanvi Singh, Editorial Assistant has reported this brief.

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