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Union of India - Section

Section 50 in The Medical Devices Rules, 2017

50. Application of rule 122DD of Drugs and Cosmetics Rules, 1945 with regard to Ethics Committee.

(1)The Ethics Committee constituted under rule 122DD of the Drugs and Cosmetics Rules, 1945 shall perform the functions and duties under these rules and shall be deemed to be constituted under these rules.
(2)The provisions of Ethics Committee provided in rule 122DD of the Drugs and Cosmetics Rules, 1945 shall, except where specifically provided under these rules, be applicable mutatis mutandis, for the purpose of clinical investigation and clinical performance evaluation under this Chapter.