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 ...

(xiv) Other active medical devices An active medical device to which provisions of sub-paragraphs (xii) and (xiii) do not apply shall be assigned to Class A. (xv) Medical devices incorporating medicinal products (a) Subject to clause (b), a medical device shall be assigned to Class D, if it incorporates as an integral part a substance which, — (1) if used separately, may be considered to be a medi ...

3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945. 4. Robust system for evaluation of applications of clinical trial and new drug which contains data of Chemistry, Manufacture, Control ...