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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