(1)The Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to,-(i)import of all Classes of medical devices;(ii)manufacture of Class C and Class D medical devices;(iii)clinical investigation and approval of investigational medical devices;(iv)clinical performance evaluation and approval of new in vitro diagnostic medical devices and;(v)co-ordination with the State Licensing Authorities.(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,-(i)manufacture for sale or distribution of Class A or Class B medical devices;(ii)sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
