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Can someone please give the details of the process of getting manufacturing a Class C device? It will be helpful if you could please include details like the forms to be submitted and how much time it can take.
The procedure to get the manufacturing license of a Class C medical device is as follows:
1. The applicant has to submit the application in Form MD-7 along with the relevant documents as specified in the Fourth Schedule (Part I, Part II and Part III) and the requisite fee as per the Second Schedule to the Central Licensing Authority.
2. The Central Licensing Authority shall carry out an inspection of the manufacturing site within 60 days from the date of application, provided the data submitted by the applicant is found satisfactory.
3. If the Central Licensing Authority is satisfied that the requirements of the Medical Devices Rules, 2017 have been complied with, it shall grant the manufacturing license in Form MD-9 within 45 days from the date of inspection report.
4. The applicant also needs to submit an undertaking stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule (Quality Management System) of the Medical Devices Rules, 2017.