Pregnant or nursing women: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women who are not pregnant or nursing, would not be suitable. (b) For medical device intended for use during pregnancy, follow-up data pertaining to a perio ...

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 ...