Centre proposes faster licensing to boost medical device manufacturing

Published 28 June 2026 · health

The Union health ministry has proposed amendments to the Medical Devices Rules, 2017, to simplify and expedite the licensing process for manufacturing medical devices while

The Union health ministry has proposed amendments to the Medical Devices Rules, 2017, to simplify and expedite the licensing process for manufacturing medical devices while ensuring compliance with quality, safety and performance requirements, it said in a statement on Sunday. “The initiative is aimed at enhancing the ease of doing business, improving regulatory efficiency, and facilitating the timely availability of quality medical devices in the country. The government aims to reduce the statutory turnaround times for manufacturing licenses across various risk-based categories,” the statement said. India’s $13 billion medical device sector, as estimated by the India Brand Equity Foundation (IBEF), has been seeking regulatory reforms to reduce bureaucratic delays and promote domestic manufacturing.

Also Read | Nicotine pouches emerging as a new public health concern, finds study Bureaucratic delays Under the existing 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 products. The proposed amendments aim to reduce statutory wait times for these categories, expediting regulatory approvals without compromising established quality benchmarks. For Class B medical devices, which include low- to moderate-risk equipment such as blood pressure monitors, hypodermic needles, and pulse oximeters, the timeline for granting a manufacturing licence is proposed to be reduced from 140 days to 115 days.

For high-risk Class C and Class D medical devices, including critical life-saving technologies such as cardiac stents, hip and knee implants, and other orthopaedic implants, the timeline will be reduced from 105 days to 90 days. The draft amendments introduce defined timelines for each stage of the licensing process, from the initial scrutiny of applications and audits by notified bodies to compliance verification and the final issuance of manufacturing licences. According to the ministry, this granular approach is expected to bring greater transparency, predictability, and efficiency to the domestic regulatory framework, ultimately benefiting both the medical device industry and patients through speedier access to quality-assured medical devices.

The Centre has put the draft notification in the public domain for comments and suggestions from all stakeholders. The notification is available in the Official Gazette and on the website of the Central Drugs Standard Control Organisation (CDSCO). Stakeholders are invited to submit their comments and suggestions within 30 days. Also Read | Govt widens drug track-and-trace net to fight fake medicines