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2023-06-09T05:21:18
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Powers of search and seizure, etc.The Medical Devices Officer may enter any premises related to clinical inve

Powers of search and seizure, etc. The Medical Devices Officer may enter any premises related to clinical investigation or clinical performance evaluation, with or without an expert, with prior approval of the Central Licensing Authority, with or without prior notice, to inspect the facilities, search and seize, record, data, documents, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 52 of 248 books, and medical devices including investigational medical devices or new in vitro diagnostic medical device. 57. Maintenance of record Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or his agent holding a permission under this Chapter shall maintain such data, record, registers and other documents for a period of seven years after completion of such investigation 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 56. 58. Disclosure of name, address, etc., of persons involved in clinical investigation or clinical performance evaluation Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or clinical performance evaluation or any agent authorised by any of them, 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 clinical investigation.

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