New Delhi, the 13th September, 2019 G.S.R. 652(E).—Whereas the draft of certain rules further to amend the Medical Devices Rules,
2017, was published as required by 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. 188(E), dated the 6 th March, 2019, 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 thirty 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 Official Gazette were made available to the public on 8 th March, 2019; And whereas no objections or suggestions were received from the public on the said rules for consideration by the Central Government; Now, therefore, in exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the 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, 2019. (2) They shall come into force on the date of their publication in the Official Gazette.
Paragraph 2
2. In the Medical Devices Rules, 2017, in the Appendix, in Form MD-10, for the words “State Licensing Authority”, the words “Central Licensing Authority” shall be substituted.
[F. No. X. 11014/31/2018-DR] Dr. MANDEEP K. BHANDARI, Jt. Secy. Note : The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number 78(E), dated the 31 st January, 2017 and last amended vide notification number G.S.R. 318(E), dated the 18 th April, 2019.