CDSCO Launches Online Risk Classification Module for Non-IVD Medical Devices

The notice stated,

"In order to simplify the regulatory approval procedures and ease 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."

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

As per the Medical Device Rule, 2017, medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, into the following classes:

(i) low risk-Class A;

(ii) low moderate risk-Class B;

(iii) moderate high risk-Class C;

(iv) high risk-Class D

To view the official notice, click the link below: