Medical Device License

Medical devices are regulated under the Medical Devices Rules, 2017 issued under the Drugs and Cosmetics Act, 1940. Depending on the nature of the business and the risk classification of the medical device (Class A, B, C, or D), different regulatory approvals are required for manufacturing, sale, import, and distribution.

Vivatrix Pharma Consultancy Services provides comprehensive regulatory support for manufacturers, distributors, retailers, healthcare institutions, importers, and start-ups involved in the medical device sector. We assist clients throughout the licensing process, from regulatory classification and documentation to application submission, inspection readiness, and post-approval compliance.

Our team ensures that applications comply with the applicable provisions of the Medical Devices Rules, 2017 and the requirements of the Central Licensing Authority (CDSCO) and the State Licensing Authorities.