21. Application for manufacturing Class C or Class D devices.
(1)An application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for licence or loan licence to manufacture for sale or for distribution, as the case may be, of Class C or Class D medical device in Form MD-7 or Form MD-8, respectively.(2)The application in Form MD-7 or Form MD-8 referred to in sub-rule (1) relating to Class C or Class D medical device, as the case may be, shall be accompanied with a fee as specified in the Second Schedule along with documents as specified in clause (ii) of Part II of the Fourth Schedule.(3)The Central Licensing Authority may, wherever required, in case of Class C or Class D medical devices, use the services of any expert in the relevant field for scrutiny of application and other technical documents.(4)The scrutiny referred to in sub-rule (3) shall be completed by the Central Licensing Authority within a period of forty five days from the date of online submission of application.(5)In case, where the documents are found to be complete and in order, the Central Licensing Authority shall cause an inspection of the manufacturing site carried out under rule 23 by a team of officers accompanied by such experts, as may be considered necessary.(6)The Central Licensing Authority may, where required, avail the services of a Notified Body referred to in sub-rule (4) of rule 13 for inspecting the manufacturing site of Class C and Class D medical devices.(7)In case, where the documents furnished with the application referred to in sub-rule (1) are not found to be complete and in order, the Central Licensing Authority shall reject the application and inform the applicant of the reasons for such rejection electronically:Provided that where deficiencies that can be rectified, are pointed out by the Central Licensing Authority within the stipulated period, the period referred to in sub-rule (4) shall reckon from the date these deficiencies have been removed.
