The Ministry of Health and Family Welfare (MoHFW), on June 15, 2022, the Central Government, after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, these rules may be called the Medical Devices (Fourth Amendment) Rules, 2022.
In the Medical Devices Rules, 2017, in Fourth Schedule, in Part III, in Appendix II, in paragraph 7.4 relating to biological safety, in clause no. (i), the following proviso shall be inserted, namely: —
“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 recognised as having negligible Bovine Spongiform Encephalopathy risk in accordance with the recommendations of the World Organisation for Animal Health.”
These rules shall come into force on the date of their publication in the Official Gazette.
[G.S.R. 228(E]
