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2023-08-10T05:40:27
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REGISTRATION OF LABORATORY FOR CARRYING OUT TEST OR EVALUATION81. Application for registration of medical de

REGISTRATION OF LABORATORY FOR CARRYING OUT TEST OR EVALUATION 81. Application for registration of medical device testing laboratory (1) An application for grant of registration of a medical device testing laboratory to carry out testing or evaluation of a medical device on behalf of a manufacturer shall be made to the Central Licensing Authority through online portal of the Central Government in Form MD-39 accompanied with a fee as specified in the Second Schedule along with the information specified in subrule (2). (2) The application made under sub-rule (1) shall be accompanied with the following information, namely:— (i) constitution of the medical device testing laboratory; (ii) premises showing location and area of the different sections; (iii) qualification, experience of technical staff employed for testing and the person in-charge of testing; (iv) list of equipment; and (v) valid accreditation certificate issued by the National Accreditation Body for Testing and Calibration Laboratories or any other similar body as may be notified by the Central Government.

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