Risk based classification list of Class A(non-sterile and non-measuring) medical device

The CDSCO circular provides an authoritative risk-based classification list for Class A medical devices that are non-sterile and non-measuring. Stakeholders are informed that such devices are exempt from Chapters IV, V, VII, VIII and XI of the Medical Devices Rules, 2017, provided the manufacturer or importer completes registration under Chapter IIIB. The Appendix details numerous devices (e.g., abdominal scissors, stethoscopes, dental accessories, orthopaedic tools) with their intended use, enabling consistent regulatory interpretation across the ecosystem. This update clarifies documentation and approval expectations, reducing regulatory burden for low-risk products while maintaining traceability via registration. Companies should map their portfolios to the listed categories and ensure Chapter IIIB registration before marketing or import.