Compulsory Unique Device Identification (UDI) on Medical Device Deferred

· New Date to Implement to be Announced Later

Rule 46 of the Medical Devices Rules 2017 to defer the date of implementation of UDI

[MoH&FW Notification S.O. 877(E) dated 23 December 2021]

S.O. 877(E).—The following draft of certain rules further to amend Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given 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 drugsdiv-mohfw@gov.in.

DRAFT RULES

1. (1) These rules may be called the Medical Devices (......Amendment) Rules, 2021.

(2) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

2. In the Medical Devices Rules, 2017, for rule 46, the following rule shall be substituted, namely:—

“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.”

[F.No. X.11014/30/2021-DR]