The application for the manufacturing of small quantities of Class A or Class B or Class C or Class D of medical devices for the purpose of clinical investigations, test, evaluation, examination, demonstration or training shall be made in Form MD-12 to the Central Licensing Authority along with a fee as specified in the Second Schedule. A description of the medical device including its design, material of construction, intended use, along with the list of equipment and qualified persons need to be provided along with the application. If the applicant possesses any manufacturing licence or approval letter for undertaking research and development activities from any Government, it needs to be provided along with the application.
The Central Licensing Authority may grant a test licence in Form MD-13, or may reject the application within 30 days. The licence is valid for a period of three years and the licencee should maintain the details of quantity manufactured under the test licence.
Conditions of test licence
The licencee in Form MD-13 should use the manufactured medical device exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or training at the place specified in the licence and should maintain the record for the same including the quantity manufactured. They should allow any Medical Device Officer to verify the same.
Cancellation of test licence
If the licencee fails to comply with any provisions of the Act and these rules, the Central Licensing Authority after giving a show cause may cancel the license. The licencee may appeal against the order within 45 days to the Central Government.