CDSCO Launches Online Risk Classification Module for Non-IVD Medical Devices
New Delhi: In a significant step toward streamlining India's medical device regulatory ecosystem, the Central Drugs Standard Control Organisation (CDSCO) has introduced a new Risk Classification Module on its online portal to simplify the approval process for medical devices other than in-vitro diagnostics (IVD).
According to the circular issued by the Ministry of Health and Family Welfare, Directorate General of Health Services, the new module has been made functional on the CDSCO Online System for Medical Devices (http://cdscomdonline.gov.in) effective November 27, 2025.
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:
