2023-08-10T05:40:27
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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