Perpetual Licensing and Uniform Testing: The Centre plans a major overhaul of India’s medical device regulatory framework by removing expiry-based licences and introducing perpetual approvals, along with standardised laboratory testing norms. The proposed reforms aim to ease compliance, reduce costs, and improve product safety in a sector currently valued at $14-15 billion and expected to double by 2030.
No More Five-Year Licence Renewals
Under the draft proposal, licences for the manufacture and import of medical devices will no longer expire after five years. Instead, approvals will remain valid indefinitely, provided companies pay retention fees at prescribed intervals.
Officials said the change would eliminate repeated renewal filings and regulatory uncertainty. The existing five-year validity was introduced under the Medical Devices Rules, 2017, which came into force in 2018. Before that, medical devices were regulated under the Drugs and Cosmetics Rules, 1945, without a dedicated licensing framework.
Exporters Flag Validity Concerns
Industry bodies have welcomed the move but cautioned that exporters could face challenges in overseas markets. Rajiv Nath, forum coordinator at the Association of Indian Manufacturers of Medical Devices (AiMeD), noted that many foreign regulators require certificates with defined validity periods, typically 3 to 5 years.
He said exporters would need a digital mechanism to generate certificates reflecting validity based on fee payments, or overseas distributors could face registration hurdles.
India’s medical device exports stood at about ₹31,120 crore ($3.7 billion) in FY2024-25, with the US, Germany, China, the UAE, and Singapore among key destinations. Exports have grown 88% over the past 6 years.
Single Test Report Format For All Labs
The draft notification also proposes a uniform testing document for all registered laboratories to address inconsistencies in current reporting practices.
Under the new system, labs will be required to use a single standard format, detailing batch numbers, manufacturing and expiry dates, and results of physical, chemical, and biological tests. Officials said this would ensure consistency nationwide, with identical reporting standards across cities.
Industry representatives said the move would benefit NABL-accredited and CDSCO-recognised laboratories, while seeking clarity on references to ISO and BIS standards in the final template.
Relaxed Norms For Low-Risk Devices, Clearer Environmental Rules
The draft rules propose separate manufacturing and environmental standards for general medical devices, distinguishing them from stricter norms applied to in-vitro diagnostics such as test kits.
Manufacturers of Class A non-sterile, non-measuring devices, including basic hospital supplies like cotton wool, may only need to display a registration number on product labels, rather than a full licence number.
Environmental compliance is also set to be streamlined. While diagnostic kit manufacturers will continue to follow ISO-certified clean-room standards, producers of general devices will be required to adopt controls suited to their manufacturing processes.
Investment Push And Public Feedback Window
Officials said the reforms are aimed at attracting foreign investment, supporting startups, and strengthening public health safeguards. FDI in the medical and surgical appliances sector has reached $3.91 billion (₹27,458 crore) between April 2000 and March 2025, with initiatives like the PLI scheme further boosting investments
