In a significant regulatory overhaul, the Indian government is set to transform the licensing framework for the country's medical devices sector. The Centre plans to abolish expiry-based licenses and introduce perpetual approvals coupled with uniform laboratory testing protocols, aiming to reduce compliance burdens and enhance safety.
Key Reforms: From Renewals to Perpetual Validity
The proposed changes, detailed in a draft notification reviewed by Mint and confirmed by officials, will scrap the current system where manufacturing and import licenses for medical devices lapse after five years. Instead, licenses will remain valid indefinitely, contingent upon companies paying periodic retention fees at specified intervals.
"To keep these licences valid, companies will simply need to deposit a retention fee, eliminating the uncertainty and administrative hurdles associated with filing fresh renewal applications repeatedly," explained a government official. This move directly addresses industry concerns about the recurring paperwork and costs linked to the five-year renewal cycle established under the Medical Devices Rules, 2017.
Standardizing Quality Assurance Across Labs
Parallel to the licensing reform, the draft rules mandate a standardized format for test reports from all registered laboratories. This initiative seeks to resolve long-standing inconsistencies in reporting that have complicated regulatory oversight by the Central Drugs Standard Control Organisation (CDSCO).
"This standardizes the process, requiring laboratories to explicitly list critical details such as the device's batch number, date of manufacture, and expiry date," the official stated. The new mandatory document will ensure that a test report from a lab in Mumbai is identical in format to one from Chennai, creating a uniform language for quality assurance nationwide.
Rajiv Nath, forum coordinator at the Association of Indian Manufacturers of Medical Devices (AiMeD), welcomed the step for NABL-accredited and CDSCO-recognized labs, anticipating a clear template that references ISO and BIS standards.
Exporter Concerns and Sector Growth
While industry groups have broadly supported the domestic ease of doing business, they have flagged a potential hurdle for exporters. Overseas regulators in key markets often require certificates with a defined validity period of 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," Nath pointed out. This is crucial for a sector where exports reached approximately ₹31,120 crore (about $3.7 billion) in FY2024-25, marking an 88% growth over six years. Major export destinations include the US, Germany, China, the United Arab Emirates, and Singapore.
Broader Impact: Safety, Investment, and Simplified Norms
The regulatory exercise aims to ensure all medical equipment meets strict safety and performance benchmarks. The draft also introduces distinct manufacturing and environmental standards, separating general devices from the stricter norms for in-vitro diagnostics like test kits.
Further simplifying compliance, manufacturers of low-risk "Class A" non-sterile devices, such as cotton wool, will be allowed to display a simple "registration number" on labels instead of a full license number. The government hopes these measures will make India a more attractive investment destination in the $14-15 billion sector, projected to double by 2030.
Cumulative Foreign Direct Investment (FDI) in the medical and surgical appliances sector reached $3.91 billion (approx. ₹27,458 crore) between April 2000 and March 2025, with recent PLI schemes catalyzing further investments. Stakeholders have 30 days to submit comments on the draft notification.
