(1) Save as otherwise provided in these rules for import or manufacture of medical device which does not have predicate medical device or has undergone clinical investigation, an application for grant of permission for such medical device after completion of its clinical investigation or clinical performance evaluation, as the case may be, under Part VII shall be made to the Central Licensing Authority in Form MD24 either by an authorised agent or a manufacturer 32 himself, as the case may be, and shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule:
Provided medical device which does not have predicate medical device indicated in life threatening, serious diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme urgency, epidemic and medical devices indicated for conditions, diseases for which there is no therapy, the animal data or clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Central Licensing Authority:
Provided further that subject to other provisions of these rules, in case of medical device of which drugs are also a part, the submission of requirements relating to animal toxicology, reproduction studies, teratogenic studies, perinatal studies, mutagenicity and carcinogenicity may be relaxed in case of drugs already approved and marketed in India and supported by adequate published evidence regarding the safety of the drug.
(3) The Central Licensing Authority, after being satisfied, may grant permission to import or manufacture medical device which does not have predicate medical device or has undergone clinical investigation in Form MD25.
Permission to import or manufacture new in vitro diagnostic medical device.