(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.
