The Central Drugs Standard Control Organization (CDSCO) on November 26, 2025, issued the risk classification list of medical devices pertaining to Interventional Radiology.
The following has been stated namely: -
• It has issued a risk-classification list for medical devices specifically related to Interventional Radiology under the Medical Devices Rules, 2017. The circular categorizes devices into Class A, B, C, or D based on intended use, degree of invasiveness, duration of contact, and potential risk to patient safety—ensuring regulatory clarity for manufacturers and importers.
• Devices involving higher-risk functions, such as vascular interventions, contrast delivery, and implantable or life-supporting components, are placed under Class C or Class D.
• Moderate-risk accessories and external support devices fall under Class B, while only low-risk items qualify under Class A.
• This classification will guide regulatory submissions, licensing conditions, conformity assessment, and post-market surveillance requirements.
[Notification no. - MED-16014(12)/1/2024-eoffice]
