31. Test licence to manufacture for test, evaluation, clinical investigations, etc.
(1)Small quantity of Class A or Class B or Class C or Class D of medical devices may be manufactured for the purpose of clinical investigations, test, evaluation, examination, demonstration or training for which an application shall be made in Form MD-12 to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second Schedule.(2)The application made under sub-rule (1) shall also be accompanied with the following documents, namely:-(a)brief description of the medical device including intended use, material of construction, design and an undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such medical devices;(b)list of equipment, instruments;(c)list of qualified personnel;(d)copy of manufacturing licence issued under these rules, if any;(e)approval letter authorizing to undertake research and development activities issued by any Government organization, if any.(3)The Central Licensing Authority, after enquiry, if any, as may be considered necessary, on being satisfied that the requirements of these rules have been complied, shall grant a test licence in Form MD-13, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application is made under sub-rule (1).(4)The licencee shall maintain a record of the details of quantity of the product manufactured under test licence.(5)A licence granted under sub-rule (3) shall, unless canceled earlier, remain in force for a period of three years from the date of its issuance.
