The documentation needed to apply for a license to manufacture medical devices

To apply for a Medical Devices Manufacturing License, an applicant must provide extensive documentation to demonstrate compliance with regulatory requirements. This includes information about the premises, the company’s legal structure, the identities and qualifications of the staff, technical information about the manufacturing process, and various certifications and approvals from relevant government agencies. The documentation must be self-attested, and applicants must pay a license fee and any additional charges.

For Class A and Class B medical devices, the manufacturing license is regulated by the State Licensing Authority, and companies must fill out Form MD-3 to obtain a license, which is issued on Form 5. For Class C and Class D medical devices, the manufacturer must submit an online application using Form MD-7 to the Central Licensing Authority of the Ministry of Health and Family Welfare of the Central Government to obtain a medical device manufacturing license. The license is issued in form MD-9 once the application is approved.