The Ministry of Health and Family Welfare vide its notification dated 23rd December 2021 has notified the Medical Devices (Draft Amendment) Rules, 2021 to further amend the Medical Device Rules, 2017.
Through this amendment rule 46 which deals with unique device identification of the medical device has been substituted as follows:
“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.”
The Ministry has invited Objections/suggestions from the public on the above draft rules, which shall 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.
