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Even as the India-European Union Free Trade Agreement (India-EU FTA), announced by India and European Union on January 27, is expected to eliminate tariffs of up to 6.7% across 99.1% trade lines, enabling cost-competitive entry in European markets for medical devices and testing instruments. The domestic medical devices industry has now expressed hope that the FTA would ensure level playing field for the domestic manufacturers and act as a catalyst for exports and innovation, while the research-based firms expect that it may help European companies to explore local manufacturing and R&D.
According to the ministry of commerce, India’s medical instruments, appliances, and vital supplies built on cutting-edge manufacturing, innovation, and skilled talent are set for a quantum leap in the EU, following the FTA. The FTA enables preferential market access and unlocks opportunities in the $572.3 billion EU pharmaceutical and medical devices market.
"Tariffs of up to 6.7% eliminated across 99.1% of trade lines, enabling cost-competitive entry in European markets for lenses, spectacles, medical devices, measuring and testing instruments," it said while briefing the sector-wise gains under the FTA.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD), said, “The India–EU FTA must ensure a level playing field for India’s medical device manufacturers. With fair regulatory alignment and safeguards against predatory imports, especially from third countries, this agreement can unlock high-value collaboration, boost domestic manufacturing, and support India’s ambition to become a top-five global MedTech hub".
He said that the goal should be mutual growth anchored in quality, transparency, and patient safety under a Mutual Recognition Agreement based on common ISO standards. AiMeD is looking forward to reviewing the fine print and the follow-on cooperation discussions.
Jatin Mahajan, president, Association of Diagnostics Manufacturers of India (ADMI), said that the Association views this agreement as a catalyst for exports, innovation, and global leadership for India’s diagnostics companies.
Pavan Choudary, chairman, Medical Technology Association of India (MTaI), said, “We congratulate India and the European Union on concluding this landmark agreement, which is expected to open a new chapter in healthcare cooperation - where success will be measured not only in GDP, but in lives improved and saved".
If the fine print is in line with the announcements made, this FTA will enable India to strengthen its role as a reliable, innovation-driven partner by expanding exports of medical textiles, surgical instruments and disposables which India specializes in.
"European companies in India are hoping to benefit from lower duties, stronger participation in public procurement, and greater incentives for local manufacturing and R&D. Most importantly for patients, any eventual tariff reductions on medical devices should help improve affordability and access to advanced therapies, making this agreement a potential example of how ethical and equitable trade can reinforce health systems on both sides," added Choudary.
Elaborating ADMI's stand, Mahajan said, “The conclusion of the India–EU Free Trade Agreement marks a defining moment for India’s diagnostics and in-vitro diagnostics industry. With preferential access for over 99% of Indian exports to the European Union, the FTA significantly strengthens the global competitiveness of Indian IVD manufacturers, particularly those driven by innovation, quality manufacturing, and regulatory compliance".
For the Indian IVD sector, the agreement goes beyond tariff liberalisation. Greater regulatory cooperation, transparency on technical barriers to trade, and streamlined customs and SPS procedures will help reduce the long-standing non-tariff challenges that diagnostic exporters face in EU markets. This creates a more predictable, rules-based environment for Indian companies to scale exports of rapid tests, ELISA, CLIA platforms, reagents, and diagnostic instruments.
Importantly, the FTA aligns strongly with the ‘Make in India’ vision by enabling Indian diagnostics manufacturers, including MSMEs, to integrate deeper into European value chains while continuing to invest in R&D, quality systems, and global certifications. As demand for reliable, affordable, and scalable diagnostics rises globally, the India–EU FTA positions Indian IVD companies as trusted partners in strengthening healthcare systems across Europe, opined Mahajan.
India and the European Union have on January 27, jointly announced the conclusion of the India-EU FTA, referred to as the 'mother of all deals', at the 16th India–EU Summit, held during the visit of the European leaders to India.
The European Union is India’s one of the largest trading partners, with bilateral trade in goods and services growing steadily over the years. In 2024–25, India’s bilateral trade in goods with the EU stood at Rs. 11.5 lakh crore ($136.54 billion) with exports worth Rs. 6.4 lakh crore ($75.85 billion) and imports amounting to Rs. 5.1 lakh crore ($60.68 billion). India-EU trade in services reached Rs. 7.2 lakh crore ($83.10 billion) in 2024.
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