Introduction The introduction may contain a brief statement placing the clinical investigation in the context of the development of the investigational medical device and relating the critical features of the clinical investigation (e.g. objectives and hypotheses, target population, treatment and follow-up duration) to that development. 6. Investigational medical device and methods 6.1 Investi ...

Medical device grouping Any person who intends to apply for grant of licence in respect of medical devices for, — (i) import; (ii) manufacture for sale or for distribution; and (iii) sale, stock, exhibit or offer for sale, may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by t ...