New Delhi, June 29 -- The Union ministry of health and family welfare has proposed amendments to medical device rules to fast-track licencing approvals for moderate- to high-risk medical devices, according to people familiar with the matter. "The ministry of health and family welfare has published a draft notification in the Official Gazette proposing amendments to the Medical Devices Rules, 2017, with the objective of simplifying and expediting the licensing process for medical devices while ensuring continued compliance with quality, safety and performance requirements," read the health ministry statement. The draft notification was issued based on the suggestions made by the Drugs and Technical Advisory Board after a detailed consultation. According to the health ministry, the proposed amendments seek to rationalise the timelines for thegrant of manufacturing licences for medical devices across different risk categories. The initiative is also aimed at enhancing the ease of doing business, improving regulatory efficiency, and facilitating the timely availability of quality medical devices in the country. 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 manufacturers' applications for thegrant of manufacturing licences in each category. The proposed amendments seek to reduce these timelines, thereby enabling faster regulatory approvals while maintaining established standards of quality, safety and performance, the statement said. For Class B medical devices, which include low- to moderate-risk devices such as blood pressure monitors, hypodermic needles and pulse oximeters, the timeline for grant of manufacturing licence has been proposed to be reduced from 140 days to 115 days. Similarly, for Class C and Class D medical devices, which include high-risk devices such as cardiac stents, hip and knee implants, and other orthopaedic implants, the timeline for granting a manufacturing licence has been proposed to be reduced from 105 to 90 days....