The Central Drugs Standard Control Organisation (CDSCO) on January 02, 2026, issued a notification regarding the risk classification list of medical devices pertaining to Oncology.
The following has been stated: -
•The competent authority has classified oncology-related medical devices under the Medical Devices Rules, 2017, following publication of the draft list dated January 06, 2025.
•The classification list (Appendix A) specifies device names, intended use, and corresponding risk classes (B, C, and D).
•The intended use mentioned is only for applicant guidance, and manufacturers may specify a different intended use for their devices.
•The list is dynamic and subject to revision from time to time as per the provisions of the Medical Devices Rules, 2017.
The detailed notification is given in the document below.
[Notification No.: File No.: MED-16014(12)/1/2024-eoffice]
