The Central Drugs Standard Control Organization (CDSCO) has officially finalized the risk classification of medical devices used in interventional radiology and radiotherapy under the Medical Devices Rules, 2017. These classifications comply with the draft lists released on January 6, 2025.
The updated lists are included in Appendix A of the respective notifications and give a structured framework for defining regulatory requirements for manufacturing and import.
The CDSCO elucidates that the general intended use given for each device acts only as guidance, manufacturers may describe particular intended uses for their products. The notified classifications are active and may be revised from time to time under the Medical Devices Rules, 2017.
Each device is assigned to Class A, B, C, or D, which determines the applicable regulatory pathway to ensure safety, quality, and compliance for technologies used in radiological and therapeutic procedures.