(1) 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.
(2) 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.
(3) Subject to the supervision by the State Licensing Authority, the Notified Body shall carry out audit of manufacturing sites of Class A or Class B medical devices to verify conformance with the Quality Management System and other applicable standards in respect of such devices.
Delegation of power of Central Licensing Authority and State Licensing Authority.