83. 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 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 with 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 Licencing 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.(4)The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of medical devices intended to be tested which shall be adequate in the opinion of the Central Licensing Authority.(5)The testing and evaluation of medical devices shall be under active direction of a person whose qualification and experience is considered adequate and who shall be held responsible for reports of test or evaluation issued.(6)The applicant shall provide standards recognized under the provisions of the Act and these rules and such standards of reference as may be required in connection with the testing or evaluation of the devices for the testing of which approval has been applied for.
