Product standards for medical device (1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. (2) Where no relevant standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 11 of 248 by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia standards. (3) In case of the standards which have not been specified under subrule (1) and sub-rule (2), the device shall conform to the validated manufacturer's standards. CHAPTER III AUTHORITIES, OFFICERS AND BODIES 8. Licensing Authorities (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.