Hospitals and procurement agencies in India often ask for foreign approvals, like the USFDA or CE certification, while buying medical devices. But the Medical Devices Rules, 2017, clearly state that every medical device in India must have a valid license. This rule comes under the Drugs and Cosmetics Act, 1940, to ensure the safety, quality, and correct performance of devices used in healthcare.
All medical devices are grouped into four risk classes: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). Licensing depends on the risk class. State Licensing Authorities give manufacturing licenses for Class A and Class B devices and sales licenses for all classes. CDSCO gives import licenses for all classes and manufacturing licenses for Class C and Class D devices after a detailed technical check.
No medical device can be sold in India without a CDSCO license or a license from a State Licensing Authority. Hence, procurement agencies must make these licenses a compulsory requirement. Any other certification should be treated only as an additional requirement. This helps protect public health and ensures legal compliance in the country.