17 June, 2022

Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has issued a new gazette notification and waives off the requirement of  Transmissible Spongiform Encephalopathies (TSEs) or Bovine Spongiform Encephalopathy (BSE) Certification for registration of Medical Devices in India. This requirement is waived off wherein the material is sourced from an animal species from a country of origin recognized as having negligible Bovine Spongiform Encephalopathy risk in accordance with the recommendations of the World Organization for Animal Health.

After the publication of the above mentioned GSR No. 450 (E) dated 15.06.2022, the clause no. i of paragraph 7.4 of Appendix II (Device Master File for Medical Devices other than invitro Diagnostic Medical Devices) of Part III of Fourth Schedule of Medical Device Rules, 2017 is now been updated as under:

“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 is not necessary, if the source is from an animal species from a country of origin recognized as having negligible Bovine Spongiform Encephalopathy risk in accordance with the recommendations of the World Organization for Animal Health.” (underlined text is the new amendment).

Please click here for the GSR No. 450 (E) dated 15.06.2022