Health Ministry Proposes Faster Licences for Medical Devices

The Union Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, aiming to reduce the time taken to grant manufacturing licences for medical devices. The draft notification, published in the official gazette, seeks to simplify and expedite the licensing process while maintaining quality, safety, and performance standards, the Ministry announced on Sunday.

Medical devices under the 2017 rules are classified into four risk categories: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). The current rules prescribe specific timelines for processing manufacturing licence applications for each category. The proposed amendments would shorten these timelines, enabling faster regulatory approvals without compromising on established standards.

For Class B devices, which include items such as blood pressure monitors, hypodermic needles, and pulse oximeters, the timeline for grant of a manufacturing licence would be reduced from 140 days to 115 days. For Class C and Class D devices, which include high-risk implants like cardiac stents, hip and knee implants, and other orthopaedic devices, the timeline would be cut from 105 days to 90 days.

The draft amendments also introduce clearly defined timelines for each stage of the licensing process, including scrutiny of applications, audits 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 by ensuring timely access to quality-assured devices, the Ministry said.

The government stated that the initiative is aimed at enhancing ease of doing business, improving regulatory efficiency, and facilitating the timely availability of quality medical devices in the country. The draft notification has been placed in the public domain for comments and suggestions from stakeholders. It is available in the official gazette and on the website of the Central Drugs Standard Control Organisation. Stakeholders are invited to submit their feedback within the prescribed period.