The Manufacturing License (Test/Evaluation):
Applied via Form MD-12, license is granted in Form MD-13 is now the fastest pathway for U.S. medical device companies seeking medical device regulation, CDSCO approval, India market entry, clinical trial testing, and regulatory compliance India in 2026. This streamlined licence lets American manufacturers import or produce small batches of devices solely for testing, evaluation, clinical investigation, or demonstration purposes without the full commercial licensing burden. With India’s $15 billion-plus medical device market growing at double-digit rates, U.S. firms are rushing to secure this licence to generate local data, speed up product validation, and stay ahead of tightening CDSCO requirements.
The process is simple and almost entirely online. Companies file Form MD-12 through the CDSCO’s SUGAM portal and receive approval in Form MD-13, usually within 30 to 60 days when documents are complete. The licence is valid for one year and can be renewed. It covers every risk class from low-risk Class A devices to high-risk Class D implants. Applicants submit basic technical files, a risk analysis, a testing protocol, and a letter of authorization from the parent company. Fees remain modest, typically between ₹10,000 and ₹50,000 depending on device class, making the licence far more affordable than full manufacturing or import approvals.
This targeted licence addresses a real pain point for U.S. companies. Many American medtech firms previously faced long customs delays or outright rejection when shipping prototypes for Indian clinical trials. The new Form MD-12/MD-13 route gives them a clear, legal way to move small quantities into the country for evaluation or performance studies. It also supports “Make in India” goals by letting foreign manufacturers test devices locally before committing to larger-scale production or partnerships with Indian contract manufacturers.
U.S. companies are already taking advantage.
Firms from Minnesota’s Medical Alley, California’s Silicon Valley, and Massachusetts’ Route 128 corridor are using the licence to run local clinical investigations that generate data acceptable to both CDSCO and the U.S. FDA. The licence is especially valuable for higher-risk devices that now require Indian clinical performance data under updated 2025-2026 rules. Without it, prototypes can sit in customs for weeks or months, delaying market entry and inflating development costs.
The licence fits perfectly into the broader regulatory changes sweeping India’s medical device sector. Full mandatory licensing took effect in 2025, closing earlier loopholes for low-risk items. At the same time, the SUGAM portal has been upgraded with auto-generated certificates and tighter query deadlines, making the entire approval process more predictable. For U.S. exporters, the Manufacturing License (Test/Evaluation) has become the essential first step toward full commercial approval and long-term market access.
Experts tracking the sector say the timing is ideal. “U.S. companies that secure this licence early gain a clear advantage in generating credible local data and building relationships with Indian clinical partners,” said Dr. Priya Sharma, a regulatory affairs consultant advising several Fortune 500 medtech firms. Public and industry reaction has been positive, with U.S. trade associations encouraging members to start applications as soon as possible to avoid bottlenecks later in the year.
For American businesses, the licence delivers direct financial and strategic benefits. It lowers overall development costs by allowing affordable local testing instead of expensive third-party labs in Europe or the United States. It also reduces supply chain risk by letting companies validate products closer to their target market. In an election year when healthcare affordability remains a top voter concern, anything that helps control device costs and speed innovation draws attention from policymakers and industry leaders alike.
What happens next is already clear.
The CDSCO has signaled further digital upgrades to the SUGAM portal later in 2026, including AI-assisted reviews and real-time tracking. U.S. companies that obtain the Manufacturing License (Test/Evaluation) now will be best positioned to capitalize on upcoming policy changes and potential trade incentives. Industry events in Chicago and Boston this summer are expected to feature dedicated sessions on navigating the Indian testing pathway.
The Manufacturing License (Test/Evaluation):
Applied via Form MD-12, license is granted in Form MD-13 has become the essential first step for U.S. companies seeking faster market access, lower testing costs, smoother regulatory compliance, and stronger supply chain resilience in one of the world’s fastest-growing healthcare markets. With the SUGAM portal making the process more transparent than ever, the window for smart, strategic entry is wide open in 2026.
By Mark Smith
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