New Delhi, June 28 (IANS) The Ministry of Health and Family Welfare on Sunday announced that it has proposed amendments to the Medical Devices Rules, 2017 to simplify and accelerate the licensing process for medical devices, a move aimed at improving ease of doing business and ensuring quicker access to quality medical products in the country.
The ministry has published a draft notification in the Official Gazette seeking public comments on the proposed changes, which are intended to streamline regulatory approvals while maintaining existing standards related to quality, safety and performance of medical devices.
Under the existing regulatory framework, 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 proposed amendments focus on reducing the time taken to grant manufacturing licences across various categories.
For Class B devices, which include low- to moderate-risk products such as blood pressure monitors, pulse oximeters and hypodermic needles, the timeline for granting manufacturing licences has been proposed to be reduced from 140 days to 115 days.
Similarly, the government has proposed shortening the approval period for Class C and Class D devices, which include high-risk products such as cardiac stents, hip and knee implants, and other orthopaedic implants. The timeline for granting manufacturing licences for these categories is proposed to be reduced from 105 days to 90 days.
The draft amendments also seek to introduce clearly defined timelines for every stage of the licensing process, including scrutiny of applications, audits conducted by notified bodies, verification of compliance requirements and issuance of licences. According to the ministry, these changes are expected to enhance transparency, predictability and efficiency in the regulatory framework.
The proposed measures are aimed at strengthening the medical devices ecosystem by facilitating faster regulatory approvals while ensuring that quality, safety and performance standards remain intact. The ministry said the changes would benefit both manufacturers and patients by enabling quicker availability of quality-assured medical devices.
The draft notification has been placed in the public domain and is available in the Official Gazette as well as on the website of the Central Drugs Standard Control Organisation. Stakeholders have been invited to submit their comments and suggestions within the prescribed period before the amendments are finalised.
–IANS
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