The Government of India, Ministry of Health and Family Welfare, Directorate General of Health Services, Central Drugs Standard Control Organization (Medical Devices Division), has issued a circular regarding provisions for risk classification of medical devices on the CDSCO Online System for Medical Devices.
Issued under File No. MED-16035/14/2025-eoffice and dated 4 December 2025, the circular states that a Risk Classification Module has been made operational on the CDSCO Online System for Medical Devices with effect from 27 November 2025. The module applies to medical devices other than in-vitro diagnostic medical devices and is accessible to all stakeholders.
As per the circular, applicants seeking risk classification for a medical device that does not appear in the CDSCO published classification list may submit an application through the online portal. This process will allow applicants to obtain risk classification of the device in accordance with the Medical Device Rules, 2017.
The circular has been issued to all stakeholders through the CDSCO website. Copies have also been forwarded for information to State and Union Territory Licensing Authorities, CDSCO Zonal, Sub-Zonal and Port Offices, and the IT Cell and CDAC team.
The circular has been issued by Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).