By: IPP Bureau
Last updated : June 29, 2026 9:47 am
The proposed changes seek to shorten the statutory timelines for granting manufacturing licences across various risk categories
The Ministry of Health and Family Welfare (MoHFW) has issued a draft notification proposing amendments to the Medical Devices Rules, 2017, aimed at streamlining and accelerating the licensing process for medical devices while maintaining stringent standards of quality, safety, and performance.
The proposed changes seek to shorten the statutory timelines for granting manufacturing licences across various risk categories, with the objective of improving regulatory efficiency, enhancing ease of doing business, and ensuring quicker availability of quality medical devices in India.
Under the existing Medical Devices Rules, 2017, medical devices are classified into four risk-based categories—Class A, B, C, and D, with Class D representing the highest-risk devices. The draft amendments propose reducing the licensing timelines for Class B, C, and D devices.
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 a manufacturing licence has been reduced from 140 days to 115 days.
For Class C and Class D devices, including high-risk products such as cardiac stents, hip and knee implants, and other orthopaedic implants, the proposed timeline has been shortened from 105 days to 90 days.
The draft also introduces defined timelines for every stage of the licensing process, including application scrutiny, audits by notified bodies, compliance verification, and licence issuance.
The government believes these measures will improve transparency, predictability, and efficiency within the regulatory framework while enabling patients to gain faster access to quality-assured medical devices.
The draft notification has been placed in the public domain for stakeholder consultation. Comments and suggestions can be submitted within the prescribed period. The notification is available in the official Gazette and on the website of the Central Drugs Standard Control Organisation (CDSCO).