An authorized agent having manufacturing or wholesale licence can apply for the import licence to the Central Licensing Authority through the online portal in Form MD-14 along with the required fees as specified in the second schedule and documents as specified in the fourth schedule. Any change in documents can be informed in writing before the grant of licence. Any subsequent application for licence for additional manufacturing site for the same medical device or additional medical device manufactured at the same manufacturing site shall be made by the same authorized agent along with the required fees as specified in the second schedule and documents as specified in the fourth schedule
If the Central Licensing Authority decides to the test the quality of the medical device or cause inspection of the overseas manufacturing site, the fee for such tests or inspection should be paid by the authorized agent. After examination of the documents and inspection report, if any, the Central Licensing Authority may grant a licence in Form MD-15 or reject the application with reasons in writing, within nine months from the date of application. If the application is rejected, the applicant may file an appeal to the Central Government within 45 days and the Central Government may dispose the appeal within a period of 90 days.
If a free sale certificate is granted by the regulatory authorities of countries like Australia, Canada, Japan, European Union Countries, or the United States of America, the import licence will be granted without any clinical investigation. If it is imported from any other country then for Class A or Class B medical devices, the safety and performance must be established through published data or through clinical investigation in the country of origin along with a free sale certificate. In case of Class C and Class D medical devices, the safety and effectiveness must be established through clinical investigation in India as specified under provisions of Chapter VII of Medical Devices Rules 2017. For the import of investigational medical device or new in vitro diagnostic medical device, prior permission in Form MD-27 or Form MD-29 from the Central Licensing Authority is required before the grant of import license.
Validity of the Licence
The licence in Form MD-15 shall remain Valid in perpetuity unless it is suspended or cancelled, provided the licencee pays the retention fees as specified in the Second Schedule for each overseas manufacturing site and for each licenced medical device every five years on or before the due date. The late fee is two percent of the retention fee for each month and should be paid within 90 days along with retention fee, failing which the registration certificate is deemed to have cancelled.