(1) Small quantity of any class of medical device may be manufactured for the purpose of clinical investigations, test, evaluation, examination, demonstration or training for which an application shall be made in Form MD10 to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second Schedule.
(2) On receipt of an application for test licence in the form and manner specified in sub-rule (1) and (2), the Central Licensing Authority shall, on being satisfied, grant the test licence in Form MD11.
(3) The licensee shall keep a record of, and shall report to the Central Licensing Authority, the date and quantity of product manufactured under test licence.
Duration of licence for clinical investigations, test, analysis, demonstration and training.
28. A licence in Form MD11 shall, unless cancelled earlier, be in force for a period of three years from the date of issue.
Cancellation of licence for clinical investigations, test, analysis, demonstration and training