India’s Union Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017 to shorten manufacturing licence approval timelines for medical devices, a move aimed at improving regulatory efficiency, enhancing ease of doing business and accelerating the availability of quality medical devices in India.
The ministry has issued a draft notification seeking stakeholder comments on the proposed changes, which seek to simplify and expedite the licensing process while maintaining existing standards for quality, safety and performance.
Shorter approval timelines proposed
Under the proposed amendments, the timeline for granting manufacturing licences for Class B medical devices has been reduced from 140 days to 115 days.
Class B devices include low- to moderate-risk products such as blood pressure monitors, hypodermic needles and pulse oximeters.
For Class C and Class D medical devices, which cover high-risk products including cardiac stents, hip and knee implants, and other orthopaedic implants, the proposed timeline has been reduced from 105 days to 90 days.
Medical devices in India are classified into four risk-based categories—Class A, Class B, Class C and Class D—with Class D representing the highest-risk category.
Greater transparency in licensing process
Besides reducing overall approval timelines, the draft amendments introduce clearly defined timelines for every stage of the licensing process, including application scrutiny, audits by notified bodies, compliance verification and licence issuance.
The ministry said the proposed framework is expected to improve transparency, predictability and efficiency in the regulatory system, enabling manufacturers to secure approvals faster while ensuring compliance with quality and safety requirements.
Industry expected to benefit
The proposed changes are expected to provide a significant boost to India’s medical devices sector by reducing regulatory delays and enabling quicker commercialisation of products. Faster approvals could also improve patient access to quality-assured medical devices while supporting domestic manufacturing under the government’s ease of doing business initiatives.
The draft notification has been published in the Official Gazette and placed on the website of the Central Drugs Standard Control Organisation (CDSCO) for public consultation. Stakeholders have been invited to submit comments and suggestions within the prescribed period before the amendments are finalised.