Medical Devices Rules 2017 Update: Centre Proposes Faster Licensing While Retaining Safety Standards
The Union Ministry of Health and Family Welfare (MoHFW) has issued a draft notification proposing key amendments to the Medical Devices Rules, 2017. The initiative aims to simplify and accelerate the licensing process for medical devices across the country while strictly maintaining existing quality, safety, and performance standards.
The Union Ministry of Health and Family Welfare (MoHFW) has issued a draft notification proposing key amendments to the Medical Devices Rules, 2017. The initiative aims to simplify and accelerate the licensing process for medical devices across the country while strictly maintaining existing quality, safety, and performance standards.
According to the Ministry's official statement on Sunday, the draft amendments focus on rationalizing and reducing the statutory timelines required to grant manufacturing licenses. The move is designed to boost the ease of doing business, improve overall regulatory efficiency, and ensure that patients gain faster access to quality-assured medical hardware. Ministry of Health to Convene 16th Conference of Central Council of Health and Family Welfare on June 29.
Under the current Medical Devices Rules of 2017, medical equipment is classified into four risk-based categories: Class A, Class B, Class C, and Class D, with Class D representing the highest-risk products. The proposed changes will noticeably shorten the regulatory window for approving these tiers.
For Class B medical devices-which cover low-to-moderate risk equipment such as blood pressure monitors, pulse oximeters, and hypodermic needles-the timeline to grant a manufacturing license is proposed to be cut from 140 days down to 115 days. Similarly, for high-risk equipment under Class C and Class D—including critical devices like cardiac stents, hip implants, and knee replacements—the wait time for a license will drop from 105 days to 90 days.
To ensure greater administrative transparency, the draft notification also introduces explicitly defined deadlines for every individual stage of the application workflow. This includes structured timelines for application scrutiny, audits by notified bodies, compliance verification, and the final issuance of the license. Union Ministry of Health and Family Welfare Amends Drugs Rules, 1945; Exemption for Sale of Cough Syrups in Small Villages Withdrawn.
The Ministry has placed the draft notification in the public domain via the Official Gazette and the website of the Central Drugs Standard Control Organisation (CDSCO). All industry stakeholders, experts, and members of the public have been invited to submit their comments and suggestions within the prescribed window before the amendments are finalized.
(The above story first appeared on LatestLY on Jun 28, 2026 02:40 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).
