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. 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.