The Department of Health and Family Welfare vide notification dated 15th June, 2022. has issued the Medical Devices (Fourth Amendment) Rules, 2022. The amendment has exempted the requirement of obtaining certificate of test to detect viruses like Transmissible Spongiform Encephalopathies (TSEs) or Bovine Spongiform Encephalopathy (BSE) during import of medical substance extracted from animals under following conditions:
- 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.
