Swift & Safe: India’s New Express Medical Device Licensing

The Union Health Ministry has proposed key amendments to the Medical Devices Rules, 2017, significantly cutting the time required to grant manufacturing licenses across all risk categories (Class A through D). Aimed at boosting the ease of doing business and enhancing regulatory efficiency, the reform ensures quicker market availability of quality medical devices in India while strictly maintaining safety and performance standards. Under the draft rules, approval timelines for low-to-moderate-risk Class B devices (e.g., blood pressure monitors) will drop from 140 to 115 days. For high-risk Class C and D devices (e.g., cardiac stents and implants), the timeline shrinks from 105 to 90 days. By defining clearer, accelerated windows for application scrutiny, audits, and compliance checks, this reform is set to streamline regulatory pathways, empower domestic manufacturing, and rapidly scale India’s medical device ecosystem.

News by Rahul Yelligetti.