The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, aimed at reducing the time required to grant manufacturing licences for medical devices across various risk categories.
According to a draft notification published in the official gazette on June 28, the proposed changes seek to streamline and accelerate the licensing process while continuing to uphold quality, safety and performance standards. The ministry stated that the move is intended to improve ease of doing business, strengthen regulatory efficiency and ensure timely access to quality medical devices in the country.
Under the existing Medical Devices Rules, 2017, medical devices are categorised into four risk-based classes Class A, Class B, Class C and Class D with Class D representing the highest-risk category. The rules currently specify timelines for processing manufacturing licence applications for each category.
The proposed amendments aim to shorten these timelines to facilitate faster regulatory approvals without compromising established quality and safety benchmarks.
For Class B medical devices, which include low- to moderate-risk products such as blood pressure monitors, hypodermic needles and pulse oximeters, the proposed timeline for granting manufacturing licences has been reduced from 140 days to 115 days.
Similarly, for high-risk Class C and Class D medical devices, including cardiac stents, hip and knee implants, and other orthopaedic devices, the proposed approval timeline has been reduced from 105 days to 90 days.
The draft amendments also propose fixed timelines for various stages of the licensing process, including application scrutiny, audits by notified bodies, compliance verification and licence issuance. The ministry said this would enhance transparency, predictability and overall efficiency in the regulatory framework, benefiting both the medical device industry and patients through quicker access to quality-assured medical technologies.
The draft notification has been released for public consultation and is available in the official gazette and on the website of the Central Drugs Standard Control Organisation (CDSCO). Stakeholders have been invited to submit their comments and suggestions within the stipulated period.
