The Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services has issued a major circular. It states that all medical devices in India need a valid domestic license before they can be sold or purchased. This rule follows the Medical Devices Rules, 2017, made by the Ministry of Health and Family Welfare. The main goal is to ensure safe, good-quality medical devices for patients across the country.

No Sale without CDSCO or State License

The circular says that no medical device can enter the Indian market without a license from CDSCO or the State Licensing Authorities. Hospitals and procurement agencies earlier asked for foreign certifications like the USFDA or CE marks as bid requirements. The circular clearly says that a CDSCO license or a State license is the primary mandatory document for procurement. Any other certificate can only be an additional requirement.

Medical Devices Classified by Risk Levels

Medical devices in India are kept under full regulation according to the risk they pose. Manufacturing licenses for Class A and B devices, and sale licenses for all device classes, come from State/UT Licensing Authorities. Import licenses for all risk classes and manufacturing licenses for Class C and D devices are granted by CDSCO itself after a detailed technical check.

Hospitals and Agencies Must Follow New Procurement Rule

The circular directs hospitals, health institutions, and all procurement agencies to accept only those devices that hold a valid domestic license under the Medical Devices Rules, 2017. Without this license, no medical device is allowed to be sold in the country. This step strengthens public health safety and brings strict compliance to every stage of import, manufacturing, sale, and distribution of medical devices in India.