Confiscation of medical devices, implements, machinery, etc. (1) Where any person has been convicted for contravening any provisions of the Act or any of these rules, the stock of medical device in respect of which the contravention has been made, shall be liable to confiscation. (2) Where any person has been convicted for manufacturing any medical device which is misbranded, adulterated or spuri ...

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 ...

Records of validation shall be maintained. 7.5.2.2 Particular requirements for sterile medical devices The manufacturer shall establish documented procedures for the validation of sterilization processes. Sterilization processes shall be validated prior to initial use. The records of validation of each sterilization process shall be maintained. 7.5.3 Identification and traceability: