The Ministry of Health and Family Welfare on 20th September 2022, has notified the Medical Devices (Draft Amendment) Rules, 2022 and has invited comments and suggestions from the public which shall be addressed to the Under Secretary (Drugs), 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 within a period of 7 days.
Through this amendment, a new chapter IIIB which deals with registration of class A (Non-Sterile and/or Non-measuring) medical devices has been notified which shall be applicable to all non-sterile and/or non-measuring devices classified as Class A medical devices. These medical devices shall be registered through an identified online portal.
The manufacturer of a medical device shall upload the details relating to that medical device for registration on the “Online System for Medical Devices. After furnishing of the information on the “Online System for Medical Devices”, registration number will be generated.
The manufacturer/ importer shall maintain the records of manufacturing/ import along with its sales or distribution. The manufacturer and importer shall produce the records, labels, Instructions for Use, on request by Licensing Authorities. The Licensing Authorities may verify the records, documents at any point of time and investigate quality or safety related failures or complaints.
