The Union Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, aimed at streamlining the licensing process for medical device manufacturers by reducing approval timelines while maintaining quality, safety and performance standards.
According to a draft notification published in the Official Gazette, the proposed amendments seek to simplify regulatory procedures, improve efficiency and enhance the ease of doing business in the medical devices sector. The initiative is also expected to facilitate faster availability of quality medical devices in the country.
Under the Medical Devices Rules, 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 seek to reduce the statutory timelines for granting manufacturing licences across different categories.
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 Class C and Class D medical devices, including high-risk products such as cardiac stents, hip and knee implants, and other orthopaedic implants, the proposed approval timeline has been reduced from 105 days to 90 days.
The draft amendments also 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 these measures are expected to improve transparency, predictability and regulatory efficiency.
According to the Ministry, the proposed changes will benefit both the medical devices industry and patients by enabling quicker regulatory approvals without compromising established standards of quality, safety and performance.
The draft notification has been placed in the public domain for comments and suggestions from stakeholders. Interested stakeholders can submit their feedback within the prescribed period through the Central Drugs Standard Control Organisation (CDSCO).
