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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

The Ministry of Health and Family Welfare has issued Medical Devices (Amendment) Rules, 2023

02-Jun-2023 | G.S.R. 409(E)

The Ministry of Health and Family Welfare has issued Medical Devices (Amendment) Rules, 2023 By virtue of the Notification, following shall be inserted in the Medical Devices Rules, 2017, namely: 1.In rule 3, after sub-rule (zu), (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. 2. 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. 3. after sub-rule (2)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. Please refer to the document attached to find the entries inserted.

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