New provision for Risk Classification of Medical Devices on the CDSCO Online System for Medical Devices

The Central Drugs Standard Control Organization (CDSCO), Medical Devices Division, under the Directorate General of Health Services, issued a circular announcing the operationalisation of a new Risk Classification Module on the CDSCO Online System for Medical Devices.

Key points include:

1. Effective from 27 November 2025, the module aims to simplify regulatory approval procedures and ease the process of risk classification for medical devices other than In-Vitro Diagnostic (IVD) devices.
2. Applicants seeking classification for devices not already included in the CDSCO-published risk classification list can now submit applications online through the portal in accordance with the Medical Device Rules, 2017.
3. This initiative enhances transparency, reduces procedural delays, and supports stakeholders by providing a centralized digital mechanism for classification determination.
4. The circular applies to all stakeholders and has been communicated to State/UT Licensing Authorities, CDSCO field offices, and technical teams for implementation.