(1) Medical device or in vitro diagnostic medical device, the import of which is otherwise not approved, may be allowed by the Central Licensing Authority to be imported in such quantities as may be necessary for the purpose of clinical investigations, test, evaluation, and demonstration or training.
(2) The quantity considered necessary shall be determined by the Central Licensing Authority after taking into account the clinical investigation or approved clinical investigation plan or information and documents submitted by the applicant.
(3) An application for an import licence for test, evaluation or demonstration or training shall be made to the Central Licensing Authority in Form MD14 and shall be accompanied by the fee as specified in the Second Schedule.
(4) On receipt of an application under sub-rule (2), the Central Licensing Authority shall, on being satisfied about the contents and the documents enclosed with the application, grant the test licence in Form MD15.
(5) The medical device for which the test licence is granted under sub-rule (4), shall, be used exclusively for purposes of clinical investigation, test, evaluation, demonstration or training, as the case may be, and such clinical investigations, test, evaluation, demonstration or training, shall be conducted in the place specified in 21 such test licence.
(6) The holder of test licence shall maintain record of the activities undertaken including the name of manufacturer, quantity imported and date of import.
(7) The consignment of medical device shall be accompanied by an invoice or statement showing the name and address of the manufacturer and the name and quantity of medical device.
(8) A licence in Form MD15 shall, unless cancelled earlier, be in force for a period of three years from the date of issue.
(9) The medical devices including in vitro diagnostic medical device referred in sub-rule (5) that are not used may be permitted to be exported or destroyed under intimation to the Central Licensing Authority.
Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient.