Under the proposed changes, licenses to manufacture and import medical devices will no longer expire after five years, but will remain valid indefinitely, provided companies regularly pay retention fees. At the same time, all registered laboratories will be required to submit test reports in a standardized format to address long-standing discrepancies that complicate regulatory oversight.
Together, the measures are intended to simplify compliance, reduce costs and improve product safety, while making India a more attractive destination for medical device investment.
“For these licenses to be valid, companies will simply have to deposit an advance fee (at specified intervals), removing the uncertainty and administrative hurdles of repeatedly applying for fresh renewals,” said one of the officials.
The current five-year validity was introduced under the Medical Devices Regulations, 2017, which came into force on 1 January 2018; before that, medical devices were regulated under the broader Drugs and Cosmetics Rules of 1945, which did not have a distinct licensing structure for devices.
Export barriers
Industry groups generally welcomed the move but warned of potential complications for exporters.
Rajiv Nath, forum coordinator of the Association of Indian Medical Device Manufacturers (AiMeD), said that while perpetual licenses facilitate domestic business, overseas regulators often require certificates with a defined validity period, such as three to five years, to approve imports. “We need a simple software option that will allow us to print certificates with this data based on our fee payments, otherwise our overseas distributors will have difficulty registering Indian products.”
Exports of medical devices from India reached approx ₹31,120 crore (about $3.7 billion) in FY 2024-25, with key markets including the US, Germany, China, UAE and Singapore. The sector has seen an 88% increase in exports over the past six years.
Together with the licensing reform, the draft notification sets out a mechanism for standardized testing and introduces a single mandatory document that all registered laboratories must use for test reports.
“This standardizes the process and requires laboratories to explicitly mention critical details such as device lot number, date of manufacture and expiry date, along with specific results of physical, chemical and biological tests. This creates a uniform language for quality assurance across the country and ensures that a report from a Mumbai lab looks exactly the same as a report from Chennai,” the official said.
“This is a very welcome step for all NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratories and CDSCO (Central Drugs Standard Control Organisation) recognized laboratories to have a standard test report format. We look forward to the detailed template and hope it will provide clear reference to ISO (International Organization for Standardization) and/or BIS (BIS) reference,” said Naccitred.
The proposed rules also establish different manufacturing and environmental standards for general medical devices, separating them from the stricter standards that currently apply to in vitro diagnostics such as test kits.
“This exercise is being carried out to ensure that all medical equipment entering the market meets strict safety and performance standards,” the second official said. “For industry, this move reduces ambiguity and costs, while promising safer products for public health.” The official added that by simplifying the licensing life cycle, the government hopes to attract more foreign direct investment and support domestic startups.
Foreign direct investment (FDI) in the medical and surgical equipment sector grew steadily, with cumulative inflows reaching US$3.91 billion, or approx. ₹27,458 crore, between April 2000 and March 2025, while recent initiatives such as the Production Incentives (PLI) scheme have further catalyzed investment and attracted nearly ₹2 trillion in manufacturing sectors, including medical devices, by September 2025.
Manufacturers of low-risk essential products are also poised to receive relief. For non-sterile and non-measuring “Class A” devices, such as common hospital supplies including cotton swabs, the draft rules allow manufacturers to display a simple “registration number” on product labels instead of a full manufacturing or import license number, the official said.
In addition, the government is specifying requirements for factories to comply with environmental regulations. While manufacturers of sensitive diagnostic kits will continue to be required to adhere to strict ISO-certified cleanroom standards, manufacturers of other general medical devices will only need to adopt environmental controls appropriate to their specific manufacturing processes.
Stakeholders and the public were given 30 days to review the draft notice and submit comments. Inquiries sent to a spokesperson for the Ministry of Health went unanswered.
