CDSCO LAUNCHES NEW ONLINE MODULE TO FAST-TRACK MEDICAL DEVICE RISK CLASSIFICATION
NEW DELHI, DEC 2025 – In a significant move to streamline regulatory processes, the Central Drugs Standard Control Organization (CDSCO) in India has introduced a new, mandatory online module for the risk classification of medical devices. The Circular, issued on December 4, 2025, announced that a new Risk Classification Module has been made functional on the CDSCO Online System for Medical Devices, effective from November 27, 2025. The stated goal of this initiative is to “simplify the regulatory approval procedures and ease the process of risk classification” for the industry.
WHAT CDSCO'S NEW RISK CLASSIFICATION MODULE MANUFACTURERS NEED TO KNOW: YOUR MANDATORY NEW FIRST STEP
This change directly impacts how medical device manufacturers and applicants seek approval for new products, particularly those that are not yet officially listed by the CDSCO.
1. Mandatory Online Classification for New Devices
For any medical device that is not currently listed in the CDSCO’s published classification database, applicants must now submit their request for risk classification through this new online module on the CDSCO portal (cdscomdonline.gov.in).
2. Scope: Non-IVD Devices
The new module is specifically designed for the risk classification of medical devices other than In-vitro Diagnostic (IVD) medical devices. This clearly carves out a digital pathway for general medical equipment, implants, and consumables.
3. Simplified, Clearer Regulatory Path
The introduction of a dedicated online module aims to standardize the initial, crucial step of determining a device’s risk class (Class A, B, C, or D) under the Medical Device Rules, 2017. By making this process digital and centralized, the government is reducing ambiguity and eliminating potential regulatory bottlenecks that can delay a device’s time-to-market.
The impact for manufacturers is a clear directive: for a novel medical device, obtaining the official classification from the CDSCO via the new online module is now a mandatory pre-licensing requirement. This enforces accuracy and compliance right from the start of the regulatory journey.