New CDSCO Risk Classification Module for Medical Devices

The Government of India has introduced a new Risk Classification Module on the CDSCO Online System for Medical Devices. This update simplifies the approval process and makes it easier to classify medical devices that are not listed in the CDSCO published classification list. The module became active on 27 November 2025 under the Medical Device Rules, 2017. Any applicant can now submit device details through the CDSCO medical device portal to get the correct risk category for the product. This new system supports faster regulatory review, improves compliance, and helps ensure the safe use of medical devices across the country. The change also supports better transparency and smoother processing of applications for medical device risk classification.