CDSCO Launches New Online Risk Classification Module for Medical Devices

The Central Drugs Standard Control Organisation (CDSCO) has introduced a new risk classification module on its online portal to streamline regulatory approvals for medical devices, excluding in-vitro diagnostic (IVD) devices. The initiative, effective from November 27, 2025, allows applicants to obtain risk classification for devices not listed in CDSCO’s published classification list under the Medical Device Rules (MDR), 2017.

Medical devices are classified into four risk categories: Class A (low risk), Class B (low-moderate), Class C (moderate-high), and Class D (high risk), based on intended use and other parameters outlined in the MDR. The system aligns with CDSCO’s broader digital regulatory framework, including the ONDLS portal, aimed at simplifying licensing, compliance, and post-approval processes. This move supports better regulation and international standardization of India’s growing medical device sector.

09-12-2025