CDSCO Launches Online Risk Classification Module for Medical Devices to Simplify Approvals

The module is now live on the CDSCO Online System for Medical Devices as of November 27, 2025.

The Central Drugs Standard Control Organisation (CDSCO) has rolled out a new online risk classification module for medical devices, excluding in-vitro diagnostic (IVD) devices, to simplify and accelerate regulatory approval procedures under the Medical Device Rules (MDR), 2017.

The module is now live on the CDSCO Online System for Medical Devices as of November 27, 2025.

In a circular, Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi said the module is designed to ease the risk classification process for devices not covered in CDSCO’s published classification list. Applicants can now submit requests through the online portal to receive official classification under MDR 2017.

The new addition aligns with CDSCO’s broader digital regulatory push, which includes the Online National Drugs License System (ONDLS) built as a single-window mechanism for processing manufacturing and sales license applications. ONDLS also covers approvals related to blood banks, COPP, GMP, WHO-GMP certificates, market standing certificates, and post-approval changes. A separate platform continues to support activities related to medical device regulation.

Under Rule 4, Chapter II of MDR 2017, non-IVD medical devices are classified based on parameters listed in Part I of the First Schedule:

• Class A: Low-risk devices

• Class B: Low-moderate risk

• Class C: Moderate-high risk

• Class D: High-risk devices

A similar structure exists for IVD devices under Part II of the Schedule. The Central Licensing Authority (CLA) is responsible for classifying devices based on intended use and specified parameters and is also empowered to revise device lists or modify classifications when required.

Accurate risk classification forms the foundation of CDSCO’s regulatory oversight, ensuring appropriate licensing pathways and compliance requirements across categories. This risk-based framework aligns Indian regulations with global standards and supports efforts to systematize a sector that has expanded significantly in recent years.

The government brought all medical devices under MDR 2017 in February 2020, marking a major shift toward structured and comprehensive regulation of the growing medical device industry.

Stay tuned for more such updates on Digital Health News