40. Test licence for import for test, evaluation, clinical investigations, etc.
(1)Notwithstanding anything contained in these rules, any medical device or in vitro diagnostic medical device may be imported for the purpose of clinical investigations or test or evaluation or demonstration or training.(2)The person who desires to import medical device under sub-rule (1), shall apply for an import licence for test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16, accompanied by such fee as specified in the Second Schedule.(3)On receipt of the application under sub-rule (2), the Central Licensing Authority shall determine, the quantity of the medical devices, after taking into account the requirement for clinical investigation, approved clinical investigation plan, and information and documents submitted by the applicant.
