The Ministry of Health and Family Welfare has released draft amendments to the Medical Devices Rules, 2017, proposing significant changes to reduce the time required for granting manufacturing licences for medical devices in India. The proposed reforms aim to simplify regulatory procedures, improve ease of doing business, and accelerate the availability of quality medical devices while maintaining existing standards of safety, quality, and performance.
Under the Medical Devices Rules, 2017, medical devices are classified into four risk-based categories:
Class A: Low-risk devices
Class B: Low to moderate-risk devices
Class C: Moderate to high-risk devices
Class D: High-risk devices
The Rules prescribe statutory timelines for processing manufacturing licence applications for each category. Through the proposed amendments, the Government plans to reduce these timelines to enable faster regulatory approvals without compromising quality, safety, or performance standards.
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 granting a manufacturing licence has been proposed to be reduced from 140 days to 115 days, resulting in a 25-day reduction.
Similarly, for Class C and Class D medical devices, which include high-risk products such as cardiac stents, hip implants, knee implants, and other orthopaedic implants, the manufacturing licence timeline has been proposed to be reduced from 105 days to 90 days, providing a 15-day reduction in regulatory processing.
According to the Ministry, the amendments are intended to streamline the licensing process, reduce procedural delays, and strengthen India's medical devices manufacturing ecosystem. Faster approvals are expected to encourage domestic manufacturing, attract investment, promote innovation, and improve patient access to essential medical devices.
The draft amendments have been placed in the public domain, and the Ministry has invited comments and suggestions from stakeholders before finalising the revised rules.
Key Highlights
- Draft amendments to the Medical Devices Rules, 2017 released for public consultation.
- Manufacturing licence timeline for Class B medical devices proposed to be reduced from 140 days to 115 days.
- Timeline for Class C and Class D medical devices proposed to be reduced from 105 days to 90 days.
- Reforms aim to speed up regulatory approvals while maintaining quality, safety, and performance standards.
- Government seeks to improve ease of doing business and strengthen India's medical devices manufacturing sector.
