New Delhi, the 15th June, 2022. G.S.R. 450(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017, was
published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 228(E), dated the 29 th March, 2022, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of forty-five days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas copies of the said Official Gazette were made available to the public on 30 th March, 2022; And whereas objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:―
Paragraph 1
1. (1) These rules may be called the Medical Devices (Fourth Amendment) Rules, 2022. (2) These rules shall come into force on the date of their publication in the Official Gazette.
Paragraph 2
2. 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.”.
[F.No. X.11014/25/2021-DR] Dr. MANDEEP K BHANDARI, Jt. Secy. Note: The Medical Devices Rules, 2017 was published in the Gazette of India, Extraordinary, Part II, section 3, sub- section(i) vide notification number G.S.R. 78(E), dated the 31 st January, 2017 and was last amended vide notification number G.S.R.356(E), dated the 18 th May, 2022.