Centre plans perpetual licences for medical devices, scraps five-year renewals

Under the proposed changes, licences for manufacturing and importing medical devices will no longer lapse after five years but will remain valid indefinitely, provided companies pay periodic retention fees. At the same time, all registered laboratories will be required to submit test reports in a standardized format to address long-standing inconsistencies that have complicated regulatory oversight.

Together, the measures are intended to simplify compliance, lower costs and improve product safety, while making India a more attractive destination for investment in medical devices.

“To keep these licences valid, companies will simply need to deposit a retention fee (at specified intervals), eliminating the uncertainty and administrative hurdles associated with filing fresh renewal applications repeatedly," one of the officials said.

The current five-year validity was introduced under the Medical Devices Rules, 2017, which came into effect on 1 January 2018; prior to that, medical devices were regulated under the broader Drugs and Cosmetics Rules, 1945, which did not have a distinct licensing structure for devices.

Exporter hurdles

Industry groups have broadly welcomed the move but flagged potential complications for exporters.

Rajiv Nath, forum coordinator at the Association of Indian Manufacturers of Medical Devices (AiMeD), said that while perpetual licences improve ease of doing business domestically, overseas regulators often require certificates with a defined validity period, like three to five years, to approve imports. “We need a simple software option that allows us to print certificates showing these dates based on our fee payments, otherwise, our overseas distributors will struggle to register Indian products."

India’s medical device exports reached approximately ₹31,120 crore (about $3.7 billion) in FY2024-25, with key markets including the US, Germany, China, the United Arab Emirates, and Singapore. The sector has seen an 88% growth in exports over the last six years.

Alongside licensing reform, the draft notification lays out the mechanics of standardized testing, introducing a single mandatory document that all registered laboratories must use for test reports.

“This standardizes the process, requiring laboratories to explicitly list critical details such as the device's batch number, date of manufacture, and expiry date, alongside specific results for physical, chemical, and biological tests. This creates a uniform language for quality assurance across the country, ensuring that a report from a lab in Mumbai looks exactly the same as one from Chennai," the official said.

“This is a very welcome step for all NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited and CDSCO (Central Drugs Standard Control Organisation) recognized labs to have a standard format test reporting format. We look forward to the detailed template and hope it provides clear provision of ISO (International Organization for Standardization) and/or BIS (Bureau of Indian Standards) standard referenced accreditation to," Nath said.

The draft rules also introduce distinct manufacturing and environmental standards for general medical devices, separating them from the stricter norms that currently apply to in-vitro diagnostics such as test kits.

“This exercise is being done to ensure that all medical equipment entering the market meets strict safety and performance benchmarks," a second official said. “For the industry, the move reduces ambiguity and costs, while for public health, it promises safer products." The official added that by simplifying the licensing lifecycle, the government hopes to attract more foreign direct investment and support domestic startups.

Foreign direct investment (FDI) in the medical and surgical appliances sector has grown steadily, with cumulative inflows reaching $3.91 billion, or approximately ₹27,458 crore, between April 2000 and March 2025, while recent initiatives such as the Production Linked Incentive (PLI) scheme have further catalyzed investments, attracting nearly ₹2 trillion across manufacturing sectors, including medical devices, by September 2025.

Manufacturers of basic, low-risk products are also set to get relief. For “Class A" non-sterile and non-measuring devices, such as common hospital supplies including cotton wool, the draft rules allow manufacturers to display a simple “registration number" on product labels instead of a full manufacturing or import licence number, the official said.

In addition, the government is refining environmental compliance requirements for factories. While manufacturers of sensitive diagnostic kits will continue to be required to follow strict ISO-certified clean-room standards, makers of other general medical devices will only need to adopt environmental controls appropriate to their specific manufacturing processes.

Stakeholders and the public have been given 30 days to review the draft notification and submit comments. Queries sent to the health ministry spokesperson remained unanswered.