Importer & Manufacturer | Source: CDSCO
Published On: 02-01-2026
Enforcement Date: 02 January, 2026
Risk classification list of medical devices pertaining to Oncology
CDSCO has issued a public notice publishing the final risk classification list for oncology medical devices, categorising 77 devices across Classes A–D under the Medical Devices Rules, 2017. The list provides intended uses and risk classes for products ranging from surgical consumables to advanced therapeutic and imaging systems, guiding manufacturing and import applications
The CDSCO public notice formalises a comprehensive risk‑based classification for 77 oncology devices, specifying intended uses and assigning classes A (low risk) to D (high risk) per MDR 2017.
Examples include
- Class A: single‑use cervical cytology instruments
- Class B: tools like breast transilluminators, flexible video bronchoscopes, scalp‑cooling systems, and balloon kyphoplasty kits
- Class C: active systems and implantables such as microwave ablation systems, electroporation therapy systems, robotic guidance systems, radiation therapy digital imagers, and implantable vascular ports
- Class D: high‑intensity technologies like stereotactic radiosurgery systems, alternating electric field anticancer systems (e.g., for GBM), brachytherapy source spacers, and embolization particles.
The notice aids regulatory affairs teams, manufacturers, and importers in determining compliance pathways.
Applicable For: Importer & Manufacturer
Reference Number: File No.:MED-16014(12)/1/2024-eoffice
Notification Link