Health Ministry issues draft Medical Devices Rules, 2016

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The Union health ministry has issued the draft Medical Devices Rules which will be applicable in respect of substances covered under sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis; substances that are in the nature of mechanical devices covered under sub-clause (ii) of clause (b) of section 3; and devices specified from time to time by the Central Government by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

Medical device already marketed in India prior to the commencement of these rules shall continue to be marketed as hitherto before subject to the condition that the manufacturer shall provide evidence of previous sale in India and apply for license within a period of ninety days from the date the device is notified under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). The Central Government shall, by notification, specify the date from which medical device referred in clause (2) shall be regulated in accordance with these rules.

Medical device already notified under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and marketed in India prior to the commencement of these rules shall continue to be marketed as hitherto before till the expiry of eighteen months from the commencement of these rules. For the purposes of these rules, the in vitro diagnostic medical devices which are already marketed in India and governed under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 shall be deemed to be medical devices and shall also continue to be marketed as hitherto before till the expiry of eighteen months from the commencement of these rules.

Under these draft rules, medical devices other than in vitro diagnostic devices shall be classified as low risk (Class A); low moderate risk (Class B); moderate high risk (Class C); and high risk (Class D).

The Drugs Controller General of India shall be the Central Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to import, manufacture of Class C and Class D medical devices, clinical investigation and clinical performance evaluation of medical devices and other related functions, provided that where any manufacturer intends to manufacture Class C or Class D medical device along with Class A or Class B medical device, the Central Licensing Authority shall be the competent for enforcement of these rules and no separate licence from the State Licensing Authorities shall be required in respect of devices of Class A or Class B.

The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to manufacture of Class A or Class B medical devices, sale, stock, exhibit or offer for sale of medical devices and other related functions: Provided that where any person intends to manufacture predicate medical device, prior approval from the Central Licensing Authority shall be necessary before applying to the State Licensing Authority.

The ministry has invited objections and suggestions from the stakeholders on the draft rules.

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