For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall include members who are Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 172 of 248 knowledgeable about pediatric, ethical, clinical and psychosocial issues. (iii) Pregnant or nursing women: (a) Pregnant or nursing women shall be included in cl ...

Studies in special populations: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other organ system failure as given below:— (i) Geriatrics: Geriatrics patients can be included in pivotal study (and in pilot study at the sponso ...