The Central Drugs Standard Control Organization (CDSCO) has classified medical devices pertaining to Interventional Radiology and Radiotherapy under the Medical Devices Rules, 2017. This action follows the publication of draft risk classification lists earlier on January 6, 2025.
Scope and Applicability
The risk classification lists for both Interventional Radiology and Radiotherapy devices are placed in Appendix A of each of the notifications.
The classifications are subject to the following conditions:
- The general intended use provided for each device serves as guidance for applicants filing for manufacturing or import under the Medical Devices Rules, 2017. However, a device may have a specific intended use defined by its manufacturer.
- The classification list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.
The classification dictates the regulatory pathway (Class A, B, C, or D) for manufacturing, import, and sale, ensuring quality and safety standards are met for these critical medical technologies.