(6)In case of application for grant of licence or loan licence to manufacture for sale or for distribution of Class B medical devices,-(i)the audit of the manufacturing site shall be carried out within ninety days from the date of application by the registered Notified Body in the manner specified in the Third Schedule;(ii)the Notified Body shall furnish its report to the State Licensing Authority within thirty days of the completion of audit;(iii)the State Licensing Authority shall, after scrutiny of documents, audit report as referred to in clause (ii) and on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class B 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 a period of twenty days from the date of receipt of the report of audit by the Notified Body.
