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Union of India - Section

Section 97 in The Medical Devices Rules, 2017

97. Savings.

- Notwithstanding the non-applicability of the Drugs and Cosmetics Rules 1945, for the substances and devices referred to in rule 2,-
(i)the licence or registration certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules, 1945, prior to commencement of these rules, shall be deemed to be valid till its expiry or for a period of eighteen months from the date these rules are notified, whichever is later, under the corresponding provisions of these rules;
(ii)new drug approval, or things done or any action taken or purported to have been done or taken, including any rule, notification, inspection, order or notice made or issued or any appointment or declaration made or any operation undertaken or any direction given or any proceedings taken or any penalty, punishment, forfeiture or fine imposed under the Drugs and Cosmetics Rules, 1945 shall, be deemed to have been done or taken under the corresponding provisions of these rules and shall always remain valid for all purposes.
First Schedule[See rule 4]Parameters for classification of medical devices and in vitro diagnostic medical devices