(4)The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class A medical devices in Form MD-5 or loan licence in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to be recorded in writing, within forty five days from the date, the application is made under sub-rule (1).Provided that,-(i)no audit of the manufacturing site shall be necessary prior to grant of licence or loan licence to manufacture for sale or for distribution of Class A medical device; and(ii)the required audit of such manufacturing site by the registered Notified Body in the manner as specified in the Third Schedule shall be carried out within one hundred and twenty days from the date on which the licence was granted by the State Licencing Authority.
