The Union ministry of health and family welfare on Sunday proposed amendments to medical device rules to fast-track licensing approvals for moderate to high-risk medical devices, according to people familiar with the matter.Under the Medical Devices Rules, 2017, medical devices are classified into four risk-based categories. (X/MoHFW_INDIA)“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,” said the health ministry statement.The draft notification was issued based on the suggestions made by the Drugs and Technical Advisory Board (DTAB) after a detailed consultation.According to the health ministry, the proposed amendments seek to rationalise the timelines for granting manufacturing licences for medical devices across different risk categories.The initiative also aims to enhance the ease of doing business, improve regulatory efficiency, and facilitate 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.Also Read:Centre proposes minimum 12-month shelf life rule for imported drugsThe Rules prescribe statutory timelines for processing manufacturers’ 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 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 days to 90 days.For the Class A category, which includes low-risk devices such as medical thermometers and stethoscopes, there has been no change.The draft amendments also introduce clearly defined timelines for each stage of the licensing process, including scrutiny of applications, audit by notified bodies, verification of compliance and issuance of licences.Also Read:Painkillers, muscle relaxants among 16 more FDCs bannedAccording to the draft notification, the applicant’s manufacturing site must conform to the requirement of the quality management system and will be verified through an audit by a notified body before the license is granted. The State Licensing Authority will ensure that the site audit is carried out by the registered notified body and that the audit report is duly submitted to the State Licensing Authority.“This is expected to bring greater transparency, predictability and efficiency to the regulatory framework, benefiting both the medical device industry and patients through faster access to quality-assured medical devices,” said the health ministry statement.The draft notification has been placed in the public domain for comments and suggestions from all stakeholders. The final notification will be published in the Gazette of India after reviewing the comments and suggestions.