Trade deals open new markets for Indian medical device makers, but import risks remain: AiMeD

Since 2000, India has signed more than 15 free trade agreements (FTAs) and other comprehensive trade pacts, expanding market access for domestic exporters. The country’s growing FTA network could open significant export opportunities for the medical devices industry, says Rajiv Nath, Forum Coordinator at the Association of Indian Medical Device Industry (AiMeD).

In 2024-25, India exported medical devices worth Rs 42,360 crore, up from about Rs 30,568 crore in 2018-19. In the first half of 2025-26 (April-December), the country has already shipped medical devices valued at about Rs 28,106 crore, according to data from the Directorate General of Commercial Intelligence and Statistics.

India’s medical devices industry, currently valued at over $15 billion, is now looking to leverage preferential market access under these latest trade agreements to expand into high-value segments and strengthen its position in global supply chains. In an interaction with the Economic Times Digital, Nath discusses how FTAs could reshape the industry, the risks from rising imports and trans-shipment, and the domestic reforms needed for India to emerge as a global manufacturing and export hub for medical devices. Edited excerpts:


ET: With India deepening its trade ties through FTAs with the UK, the European Union (EU), and New Zealand, how do you see these agreements reshaping the future of India’s medical devices industry?
Rajiv Nath (RN): India’s FTAs with the UK, EU, and New Zealand can help integrate its medical devices industry into global value chains by enabling technology partnerships, regulatory cooperation, investment, and export growth. If structured well, they can support India’s goal of becoming a global hub for high-quality medical device manufacturing.

The India-UK FTA has immediate strategic value through stronger healthcare innovation, manufacturing and market-access links. The trade deal with the EU offers the greatest long-term potential because of its advanced medical technologies and large healthcare market, while New Zealand can support niche collaboration and sharing of regulatory best practices.

These FTAs will benefit India most if they expand exports, enable technology transfer, and strengthen domestic manufacturers without increasing import dependence. They should build India’s manufacturing base and position it as a trusted supplier of affordable, high-quality medical technologies.

ET: What are the biggest opportunities these FTAs present for Indian medical device manufacturers in terms of technology transfer, global market access, and attracting investments into the sector?
RN: India’ latest FTAs can help Indian medical device makers expand beyond the domestic market by lowering market-access barriers and improving access to healthcare systems seeking reliable, cost-effective suppliers.

They can also drive technology transfer and joint innovation, giving Indian firms access to advanced manufacturing, better quality systems, and higher-value segments such as diagnostics, imaging, and digital health.

Clear trade rules and wider market access will attract global manufacturers looking to diversify supply chains, boosting India’s manufacturing ecosystem, jobs, and R&D capacity. To sustain these gains, FTAs must be backed by domestic policies that promote value addition and align with the National Medical Devices Policy, Production Linked Incentive (PLI) scheme, and cluster development programmes.

ET: While FTAs can accelerate trade, they may also increase competition from imported products. How can India strike the right balance between promoting domestic manufacturing under ‘Make in India’ and ensuring access to advanced global medical technologies?
RN: Trade liberalisation should support, not weaken, India’s domestic medical device industry. The goal should be a balanced ecosystem where global competition drives innovation, while policy support helps Indian manufacturers scale, improve quality, and compete internationally. The Make in India vision should, therefore, focus not on restricting imports but on building globally competitive manufacturing capabilities within India.

India must also guard against third-country exports being routed through zero-tariff FTA partners with little real value addition. Strong rules of origin (ROO), factory inspections, change-in-tariff-heading checks for inputs and components, and minimum value-addition norms should be strictly enforced to protect genuine Indian manufacturers.

The long-term aim should be to move India from being mainly an importer of high-value medical devices to becoming a global manufacturing base where international companies collaborate with Indian firms on production, innovation, and exports. This would strengthen both healthcare security and economic growth.

ET: How important are regulatory cooperation, harmonisation and mutual recognition of quality standards in allowing Indian medical devices to compete effectively in international markets like the UK and the EU?

RN: Regulatory cooperation is critical for Indian medical devices to compete in markets, such as the UK and EU. Even with lower tariffs, differing approval requirements can delay exports. Harmonised standards, regulatory convergence, and mutual recognition can reduce duplication, lower compliance costs, and speed up market access.

India should pursue mutual recognition for products certified under recognised standards such as UK Conformity Assessed (UKCA) marking, Conformité Européenne (CE) and relevant International Organization for Standardization (ISO) standards while strengthening domestic mechanisms such as Indian Certification for Medical Devices (ICMED) Plus and Quality Council of India (QCI) certification. This would improve confidence in Indian-made devices and ease their entry into global markets. The aim should be to remove unnecessary procedural barriers while preserving quality, safety and innovation as the foundation of medical device trade.

ET: Do you believe India’s medical device industry, particularly micro, small, and medium enterprises (MSMEs) and manufacturers in high-value, innovation-driven segments, is adequately prepared to leverage the opportunities created by these FTAs? What policy support is still needed to enhance competitiveness?

RN: India’s medical device industry is better positioned for domestic and global markets, but readiness remains uneven. Leading firms meet global standards, while many MSMEs still face constraints related to finance, technology, compliance, and market access.

To benefit fully from FTAs, India needs stronger R&D support, affordable MSME finance, better testing and certification infrastructure, and assistance with international compliance. Policy should also encourage higher domestic value addition through local-content incentives in public procurement, support for component manufacturing, including through Department of Pharmaceuticals schemes, and clinical performance studies to build trust in safety and efficacy.

Stable and predictable policies, rational taxation, medical device parks, faster approvals, transparent procurement, MSME capacity-building, and industry-academia collaboration can help Indian manufacturers scale, innovate, and move beyond contract manufacturing.

ET: Beyond tariff reductions, what structural reforms, including improvements in regulatory processes, infrastructure, ease of doing business, R&D incentives, and skill development, are needed for India to fully capitalise on these trade agreements?

RN: Regulatory and business reforms top the list. Tariff cuts must be backed by a predictable, globally aligned regulatory framework, including a dedicated medical devices law promised in the National Health Policy 2017 and recommended by Parliamentary Committee Reports 138 and 146.

India should remove arbitrary no objection certificates (NOCs) lacking legal backing, reduce compliance burdens as recommended by NITI Aayog and the committee headed by former Cabinet Secretary Rajiv Gauba, and rely more on voluntary certifications and incentives instead of punitive measures. Furthermore, continued investment in medical device clusters and parks, testing labs, calibration facilities, and logistics can lower costs, improve quality, and strengthen exports.

To promote R&D and innovation, we need stronger fiscal incentives, industry-academia collaboration, and support for commercialising indigenous technologies to accelerate innovation in high-value segments. India also needs specialised talent in biomedical engineering, precision manufacturing, quality assurance, and regulatory affairs to compete globally.

ET: Looking ahead, how do you see these FTAs contributing to India’s vision of becoming a global manufacturing and export hub for medical devices under the National Medical Devices Policy and ‘Make in India’ initiative over the next five years, particularly in terms of investment, innovation, exports, and self-reliance?

RN: There is a strategic opportunity that these FTAs bring. Over the next five years, well-designed FTAs can advance the National Medical Devices Policy and Make in India by combining cost competitiveness with quality, innovation, and resilient supply chains, positioning India as a trusted global medical device manufacturing hub.

FTAs can attract manufacturing investment, encourage multinational production in India, and connect domestic firms more deeply with global value chains, supporting technology adoption, skilled jobs, and innovation. Improved access to developed healthcare markets can also expand exports, while stronger domestic manufacturing can reduce import dependence and improve healthcare resilience.