India proposes faster licensing for medical devices

The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to shorten the time required to obtain manufacturing licenses for medical devices. The draft notification, published on Sunday, June 28, 2026, aims to expedite regulatory approvals while maintaining established standards for quality, safety, and performance.

The initiative is intended to enhance the ease of doing business, improve regulatory efficiency, and facilitate the timely availability of medical devices in India. The country's medical device sector, valued at an estimated $13 billion, has long sought regulatory reforms to reduce bureaucratic delays and promote domestic manufacturing.

Under the existing framework, medical devices are classified into four risk-based categories: A, B, C, and D, with Class D representing the highest-risk products. The proposed amendments would reduce the statutory processing times for granting manufacturing licenses across several of these categories.

For Class B devices, which include low to moderate-risk equipment such as blood pressure monitors, hypodermic needles, and pulse oximeters, the timeline would be shortened from 140 days to 115 days. For...