41. Grant of test licence for import for test, evaluation, clinical investigations, etc.
(1)If the Central Licensing Authority, after such enquiry, if any, is satisfied that the requirements of these rules have been complied, the said authority shall grant a test licence in Form MD-17, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application under sub-rule (2) of rule 40.(2)The medical device for which a test licence has been granted under sub-rule (1), shall be used exclusively for purposes of clinical investigation, test, evaluation, demonstration or training, as the case may be, and such clinical investigations or test or evaluation or training, shall be conducted at a place specified in such test licence:Provided that in cases where the medical device is required to be taken to any place other than the ones mentioned in the test licence, the Central Licensing Authority shall be informed in writing before doing so.(3)The holder of the test licence shall maintain record of the activities undertaken including the name of manufacturer, quantity imported and date of import.(4)The consignment of medical device shall be accompanied by an invoice or statement showing the name and quantity of medical device.(5)A licence in Form MD-17 shall, unless canceled earlier, be in force for a period of three years from the date of its issue.(6)The medical devices including in vitro diagnostic medical device referred to in sub-rule (2) that are not used, may be permitted to be exported or destroyed under intimation to the Central Licensing Authority.(7)Where any licencee under sub-rule (1) contravenes any provision of these rules, the Central Licensing Authority, shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.(8)The Central Licensing Authority shall after giving an opportunity to the licencee to explain, in writing, licencee's defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.(9)A licencee, whose licence has been canceled under sub-rule (8), may appeal to the Central Government within forty five days from the date of such order.
