64. Permission to import or manufacture new in vitro diagnostic medical device.
(1)An application for grant of permission to import or manufacture a new in vitro diagnostic medical device may be made to the Central Licensing Authority in Form MD-28 either by an authorized agent in case of import or a manufacturer 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 that the new in vitro diagnostic medical device used for diagnosis of life threatening, serious diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme urgency, epidemic and diagnostic medical devices used for diagnosis of conditions, diseases for which there is no diagnostic medical device available in the country, the clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Central Licensing Authority:Provided further that for new in vitro diagnostic medical device classified under Class A, data on clinical performance evaluation may not be necessary, except in cases, where the Central Licensing Authority, for reasons to be recorded in writing, considers it necessary depending on the nature of the medical device.(2)The Central Licensing Authority, may, after being satisfied with the information furnished along with application under sub-rule (1), grant permission to import or manufacture new in vitro diagnostic medical device in Form MD-29 or may reject the application, for reasons to be recorded in writing, within a period of ninety 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 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.
