(1) Where any participant is injured on account of his participation in the clinical investigation, the sponsor permitted under rule 45 shall provide medical management to that participant.
(2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and such injury is attributable to the use of investigational medical device, the sponsor permitted under rule 45 shall provide to that participant, medical management and such compensation in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945 and shall be applicable mutatis mutandis, for the purpose of medical management and such compensation in case of clinical investigation and clinical performance evaluation under this part.
(3) Where death of a participant is related to clinical investigation and is attributable to the use of an investigational medical device, the sponsor, permitted under rule 45 shall provide to the legal heir of that participant, such compensation in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945 and shall be applicable mutatis mutandis, for the purpose of such compensation in case of clinical investigation and clinical performance evaluation under this part.
Power of Medical Devices Officer in respect of clinical investigation or clinical performance evaluation.
49. The Medical Devices Officer, with or without expert, with the prior approval of the Central Licensing Authority may, with or without prior notice, enter into any premises related to clinical investigation or clinical performance evaluation to inspect the facilities, search and seize, record, data, documents, books, and medical devices including investigational medical devices.
Maintenance of record and furnishing information.
50. Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or clinical performance evaluation or his agent holding a permission under this part shall keep and maintain such data, record, registers and other documents for a period of twenty years and shall furnish such information as may be required by the Central Licensing Authority or any other officer authorised by it in this behalf under rule 49.
Disclosure of name, address, etc. of persons involved in clinical investigation or clinical performance evaluation.
51. Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or clinical performance evaluation or his agent, as the case may be, shall, if so required, disclose to the Medical Device Officer or any other officer authorised by the Central Licensing Authority, the names, addresses and other particulars of persons involved in conducting clinical investigation or clinical performance evaluation and similar 29 details in respect of participants in such clinical investigation or clinical performance evaluation.
Permission to Conduct of clinical performance evaluation for new in vitro diagnostic medical device