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 ...

As a company, we have one of the largest number of briefs on Diagnostics & Medical Devices Regulatory work. We combine this with our in-depth knowledge of drug regulations and help our clients in preparation of pamphlets, brochures, etc. and ensure they are as per the guidelines prescribed by various government departments. Besides this, we also help our clients in preparing dossiers for obtaining ...