The regulatory landscape for medical devices in India has taken a major step forward: CDSCO has activated a new online risk-classification tool on the “CDSCO Online System for Medical Devices.” The facility now live enables device-makers and applicants to request classification under MDR 2017 when their device does not appear in the existing published classification list. 

Under MDR 2017 (Rule 4, Chapter II), non-IVD devices are categorized into four classes  Class A (low risk), Class B (low-moderate), Class C (moderate-high), and Class D (high risk) based on intended use and risk parameters specified in Schedule I. The new tool ensures that any unlisted device can be assessed and classified formally, removing ambiguity for manufacturers of novel or emerging medical technologies.

Previously, applicants faced lengthy manual procedures to obtain classification approvals  a bottleneck particularly for startups, custom devices or novel innovations. With this module, CDSCO aims to cut down approval times, simplify compliance, enhance transparency and reduce regulatory friction, thereby encouraging innovation in India’s medical-device sector. 

The move is part of CDSCO’s broader digital-regulation push: earlier this year the agency published updated classification lists (including for radiotherapy, interventional radiology, cardio-neuro devices), and clarified guidelines under MDR 2017 to ensure all devices follow a risk-based regulatory pathway.  For manufacturers and importers, this module represents a much-needed single-window regulatory upgrade.

Overall analysts view this as a landmark shift: by enabling automated classification requests and faster regulatory clarity, CDSCO is likely to accelerate time-to-market for new medical devices a crucial boost for India’s growing med-tech ecosystem.