The Ministry of Health and Family Welfare on 29th March 2022 has notified the Medical Devices (Draft Amendment) Rules, 2022 to further amend the Medical Device Rules, 2017 and has invited Objections and suggestions from the public which shall be addressed to the0020e 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 within 45 days.
The Amendment is brought under Fourth Schedule, in Appendix II which deals with device master file for in VITRO Diagnostic medical devices in which item no. 7.4,in subitem no. (i), the following Proviso has been inserted.
Biological safety:
- The dossier should contain a list of all materials of animal or human origin used in the device. For these materials, detailed information should be provided concerning the selection of sources or donors; the harvesting, processing, preservation, testing and handling of tissues, cells and substances of such origin should also be provided. Process validation results should be included to substantiate that manufacturing procedures are in place to minimize biological risks, in particular, with regard to viruses and other transmissible agents. Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform Encephalopathy (BSE) Certificates should also be submitted.
“Provided that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or Bovine Spongiform Encephalopathy (BSE) Certificates shall not be necessary if the source is from animal species from a country of origin recognized as having negligible Bovine Spongiform Encephalopathy risk in accordance with the recommendations of the World Organisation for Animal Health.”
