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 authorized 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 to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United 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 Licencing Authority is satisfied with the data of safety, performance and pharma-co-vigilance of the device, and,-(a)there is no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behavior and performance in Indian 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:Provided that the Central Licensing Authority shall, where the information is inadequate with regard to the requirements as referred to in sub-rule (1), intimate the applicant in writing within the said period, for reasons to be recorded in writing, the conditions which shall be satisfied before considering the permission:Provided further that if the applicant has not furnished the required information sought by the Central Licensing Authority within ninety days from the date of intimation and the said Authority is satisfied that the information sought was possible to be furnished within the said period, it may reject the application for reasons to be recorded in writing.(3)If the applicant does not receive permission or if the application is rejected within the specified period as referred to in sub-rule (2), the applicant may appeal to the Central Government and that Government may, after such enquiry, as it considers necessary, pass such orders in relation thereto as it thinks fit within a period of sixty days from the date of appeal.
