The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, to streamline the licensing process. Under the Medical Devices Rules, 2017, medical devices are classified into four risk-based categories – Class A, Class B, Class C and Class D – with Class D comprising the highest-risk devices.

The rules prescribe statutory timelines for processing applications for manufacturing licences for each category. The proposed amendments seek to reduce these timelines, thereby enabling faster regulatory approvals while maintaining the established standards of quality, safety and performance.

The ministry has published a draft notification in this regard, which aims to reduce timelines for the grant of manufacturing licences and enhance ease of doing business. It also seeks to improve regulatory efficiency and facilitate the timely availability of quality medical devices in the country.

The Ministry said that the draft notification has been placed in the public domain for comments and suggestions from all stakeholders.