(1)An authorized agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence.(2)The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with respective documents as specified in the Fourth Schedule:Provided that any change in the documents submitted at the time of application and prior to grant of licence shall be informed, in writing, to the Central Licensing Authority.(3)Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject it to evaluation, test or examination, the authorized agent shall pay a fee for such evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.(4)Any subsequent application for,-(i)grant of licence for additional manufacturing site for the same medical device by the same authorized agent shall be accompanied with a fee and documents as referred in sub-rule (2);(ii)licence for additional medical device manufactured at the same manufacturing site shall be made by the same authorized agent accompanied with fee as specified in the Second Schedule and respective documents as specified in the Fourth Schedule.
