New Delhi, the 2nd June, 2023 G.S.R. 409(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 was
published, as required under sections 12 and 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. 157 (E), dated the 1st March, 2023, 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 seven 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 the 1st March, 2023; 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 (Amendment) Rules, 2023. (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 (hereinafter referred as the said rules), in rule 3, after sub-rule (zu), the following sub-rule shall be inserted namely:– ‘(zua) “State Medical Devices Testing Laboratory” means a medical devices laboratory established or designated by the State Government under sub-rule (3) of rule 19’.
Paragraph 3
3. In the said rules, in rule 18, in sub-rule (1), after the words “Central Government”, the words “or, as the case may be, the State Government” shall be inserted.
Paragraph 4
4. In the said rules, in rule 19,– (a) for the marginal heading, the following marginal heading shall be substituted, namely:– “Medical Device Testing Laboratories”; (b) after sub-rule (2), the following shall be inserted, namely: — “(3) (1) The State Government may, by notification, establish State Medical Devices Testing Laboratory for the purpose of, – (a) testing and evaluation of medical devices; or (b) to carry out any other function as may be specifically assigned to it. (4) Without prejudice to provisions of sub-rule (3), the State Government may also designate any laboratory having facility for carrying out test and evaluation of medical devices as State Medical Devices Testing Laboratory for the purposes specified in sub-rule (3): Provided that no medical devices testing laboratory shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.”.
[F. No. X.11014/7/2022-DR] ARADHANA PATNAIK, Jt. Secy. Note : The Medical Device Rules, 2017 were published in the Official Gazette vide notification number G.S.R. 78(E), dated the 31st January, 2017 and last amended vide notification number G.S.R. 777(E), dated the 14th October, 2022.