Medical management Where any participant is injured on account of his participation in the clinical performance evaluation, the sponsor permitted under sub-rule (5) of rule 59 shall provide medical management to that participant. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 56 of 248 CHAPTER VIII IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE 63. Permission to import or manufacture medical device which does not have its predicate device (1) Save as otherwise provided in these rules, for import or manufacture of medical device which does not have predicate medical device, an application for grant of permission for such medical device after completion of its clinical investigation under Chapter VII shall be made to the Central Licensing Authority in Form MD-26 either by an authorised agent in case of import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule: PROVIDED that the 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 in respect of investigational medical device of Class A, data on clinical investigation may not be required, except in cases, where depending on the nature of the medical device, the Central Licensing Authority, for reason to be recorded in writing, considers such data necessary: PROVIDED ALSO 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 safety of the drug. PROVIDED ALSO that, the results of clinical investigation may not be required ta be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 57 of 248 States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that country and the Central Licensing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device, and, — (a) there is no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behaviour and performance in Indicin population; (b) the applicant has given an undertaking in writing to conduct post marketing clinical investigation with the objective of safety and performance of such investigational medical device as per protocol approved by the Central Licensing Authority. (2) The Central Licensing Authority, after being satisfied with the information furnished along with application under sub-rule (1), may grant permission to import or manufacture medical device which does not have predicate medical device in Form MD-27, or may reject the application for reasons to be recorded in writing, within a period of one hundred and twenty days or such extended period, not exceeding a further period of thirty days, from the date of application: