India’s Ministry of Health and Family Welfare has published a draft notification in the Official Gazette proposing amendments to the Medical Devices Rules, 2017, aimed at simplifying and accelerating the licensing of medical devices without diluting the country’s requirements for quality, safety and performance.
The proposed changes rationalise the statutory timelines for granting manufacturing licences across the four risk-based categories defined under the Rules. The Ministry has positioned the move as part of a broader effort to enhance the ease of doing business, sharpen regulatory efficiency, and speed the availability of quality-assured medical devices for patients and providers.
Under the Medical Devices Rules, 2017, devices are classified into four risk-based categories — Class A, Class B, Class C and Class D — with Class D covering the highest-risk products. Each category carries prescribed timelines for processing manufacturing-licence applications. The draft amendments would shorten several of those windows while leaving the underlying quality, safety and performance standards intact.
For Class B devices — low-to-moderate-risk products such as blood-pressure monitors, hypodermic needles and pulse oximeters — the timeline for the grant of a manufacturing licence would fall from 140 days to 115 days.
For higher-risk Class C and Class D devices — a group that includes cardiac stents as well as orthopaedic implants such as hip and knee replacements — the timeline would be reduced from 105 days to 90 days.
Proposed timeline changes at a glance
|
Device class |
Indicative examples |
Current |
Proposed |
|
Class B |
Blood-pressure monitors, hypodermic needles, pulse oximeters |
140 days |
115 days |
|
Class C & D |
Cardiac stents, hip and knee implants and other orthopaedic implants |
105 days |
90 days |
Figures reflect the draft proposal and remain subject to consultation.
Beyond the headline reductions, the draft introduces clearly defined timelines for each stage of the licensing process — including scrutiny of applications, audit by notified bodies, verification of compliance and issuance of licences. Regulators expect the stage-wise structure to bring greater transparency, predictability and efficiency to the framework, benefiting both manufacturers and patients through faster access to quality-assured devices.
The draft notification has been placed in the public domain for comments and suggestions from all stakeholders. It is available in the Official Gazette and on the website of the Central Drugs Standard Control Organisation (CDSCO), and the Ministry has invited stakeholders to submit their feedback within the prescribed period.
Read the draft Gazette notification: egazette.gov.in/WriteReadData/2026/273896.pdf
