The Union Health Ministry published a draft notification to amend the Medical Devices Rules, 2017. The proposal aims to simplify and speed up the licensing process for medical devices to enhance the ease of doing business and ensure timely availability.
The Union Ministry of Health and Family Welfare on Sunday 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.
According to a press release, the proposed amendments seek to rationalise the timelines for the grant of manufacturing licences for medical devices across different risk categories. The initiative is 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 applications for manufacturing licences for each category.
Proposed Timeline Reductions
The proposed amendments seek to reduce these timelines, thereby enabling faster regulatory approvals while maintaining the established standards of quality, safety and performance. 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, the press release stated. 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 the grant of a manufacturing licence has been proposed to be reduced from 105 days to 90 days.
Enhancing Transparency and Efficiency
The press release further stated that 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. 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.
Call for Stakeholder Feedback
The draft notification has been placed in the public domain for comments and suggestions from all stakeholders. The notification is available in the Official Gazette and on the website of the Central Drugs Standard Control Organisation (CDSCO). Stakeholders are invited to submit their comments and suggestions within the prescribed period, the press release said. (ANI)
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