Govt to amend rules for speedy approvals for medical devices

THe unification ministry of wellness and fellowship welfare has proposed amendments to medical gimmick rules to fast-track licensing approvals for moderate- to high-risk medical devices, according to people familiar spirit 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 (DTAB) after a detailed consultation.According to the health ministry, the proposed amendments seek to rationalise the timelines for the grant 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 the grant 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 days to 90 days.For Class A devices, which include low-risk items 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.According to the draft notification, the applicant’s manufacturing site of the applicant will conform to the requirements for 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 a registered notified body carries out the site audit and duly submits the audit report 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,” read 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.