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Form MD-9

License to Manufacture for Sale or for Distribution of Class C or Class D, which is issued by the central licensing authority.

For information regarding Class C and D manufacturing licenses, please get in touch with us for further details and documentation.


1. Submit an application to the Central Licensing Authority via the designated online portal for a licence (Form MD-7 for Class C devices or Form MD-8 for Class D devices).


2. Include the specified fee from the Second Schedule and the required documents listed in clause (ii) of Part II of the Fourth Schedule.


3. The Central Licensing Authority may engage relevant experts to review the application.


4. The review will be completed within forty-five days of online submission.


5. If documents are complete, an inspection of the manufacturing site will be conducted by a team of officers and experts.


6. The Central Licensing Authority may also enlist a Notified Body for inspections.


7. If the application is incomplete, it will be rejected, and the applicant will be informed electronically. If rectifiable deficiencies are identified, the review period will be extended to allow for corrections.



Find the link below for document requirements and contact us to learn how to prepare the documents.


https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/7MD.pdf


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