the Medical Device Rules, 2016.Union territory Rules of Dadra and Nagar Haveli and Daman and Diu · 1940
(1)The Central Government shall, by notification, designate the Central Government Laboratories or Central medical device testing centres, as the case may be, to carry out performance evaluation in respect of specified in vitro diagnostic medical devices.
(2) Performance evaluation prior to grant registration, in respect of in vitro diagnostic medical devices, shall be carried out at the designated laboratories or medical device testing centres under sub-rule (1).
(3) Performance evaluation of in vitro diagnostic medical devices shall be carried out as specified by the concerned laboratory or medical device testing centre notified under sub-rule (1).
Part VIII Permission to import or manufacture medical device which does not have predicate medical device Permission to import or manufacture medical device of clinical investigation.