Proposed amendments to the Medical Devices Rules 2017
NATIONAL: The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 as an effective measure to streamline the licensing process. According to these rules, medical devices are classified into four risk-based categories – Class A, Class B, Class C and Class D – with Class D being the category for the highest-risk devices.
The rules also specify statutory timelines for processing applications for manufacturing licenses for each category. The proposed amendments aim to reduce these timelines to enable faster regulatory approvals while maintaining the established standards of quality, safety and performance.
The ministry has published a draft notification in this regard that aims to reduce timelines for the grant of manufacturing licenses 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 announced that the draft notification has been made available to the public for comments and suggestions from all stakeholders.