11 New provision for Risk Classification of Medical Devices on the CDSCO Online System for Medical Devices 2025-Dec-05 251 KB

File No.: MED-16035/14/2025-eoffice Government of India Ministry of Health & Family Welfare Directorate General of Health Services Central Drugs Standards Control Organization (Medical Devices Division)

FDA Bhawan, New Delhi Dated:

Circular

Sub: New provision for Risk Classification of Medical Devices on the CDSCO Online System for Medical Devices — Reg.

In order to simplify the regulatory approval procedures and easing the process of risk classification of medical devices other than In-vitro Diagnostic (IVD) medical devices, a new Risk Classification Module has been made functional on the CDSCO Online System for Medical Devices (http://cdscomdonline.gov.in) for all stakeholders w.e.f. 27.11.2025.

In view of the above, the applicant seeking risk classification for the device which is not listed in the CDSCO published classification list, may submit application through the said portal to obtain risk classification of device under Medical Device Rules, 2017.

ff 4 [| ‘ lO (Dr. Rajeev Sin aghuvanshi) Dr ntroller General (India)

To,

All stakeholders through CDSCO website

Copy for information to:

1. State/UTs Licensing Authorities 2. CDSCO Zonal/Sub-Zonal/Port Offices 3. IT Cell and CDAC Team