The Central Drugs Standards Control Organization (CDSCO) on December 04, 2025, issued the notification regarding the New provision for Risk Classification of Medical Devices on the CDSCO Online System for Medical Devices.
The following has been stated namely: -
• A new Risk Classification Module has been made functional on the CDSCO Online System for Medical Devices (http://cdscomdonline.gov.in) for all stakeholders with effect from November 27, 2025.
• 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.
[Notification No. MED-16035/14/2025-eofficе]