Is CDSCO Registration Mandatory for Class A & B Medical Devices?

Yes, CDSCO registration is mandatory for Class A and B medical devices in India under the Medical Devices Rules, 2017. Manufacturers, importers, and distributors dealing with these categories must obtain proper licensing—typically MD-5 for manufacturers and MD-42 for distributors—through the Central Drugs Standard Control Organization (CDSCO). While Class A devices may undergo a self-certification route, Class B devices require more detailed scrutiny. Compliance ensures legal sale, avoids penalties, and builds market trust. At Agile Regulatory, we assist businesses with documentation, portal filing, and end-to-end support for smooth CDSCO registration of Class A & B medical devices.