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2023-08-10T05:44:39
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. Registration of medical device testing laboratory(1) Before grant of registration to any medical device tes

. Registration of medical device testing laboratory (1) Before grant of registration to any medical device testing laboratory by the: Central Licensing Authority, the premises shall be inspected by the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. Medical Device Officer appointed by the Central Government with or without an expert in the concerned field for adequacy and suitability. (2.) The Medical Device Officer, after completion of the inspection, shall forward a detailed descriptive report giving findings on each aspect of inspection along witn recommendations to the Central Licensing Authority with a copy to the applicant. (3) If on receipt of the application and the report referred to in sub-rule (2), the Central Licensing Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, the Central Licensing Authority may grant registration in Form MD-40 or if not satisfied, may, reject the application, for reasons to be recorded in writing, within a period of forty-five days from the date of application.

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