New Delhi: With India meeting much of its medical device demand through imports, the India–EU FTA has advanced on curbing cost burden with significant tariff reductions on European-made devices , while nascent domestic industry anticipates regulatory alignment to unlock new markets and boost exports.
According to an guidance note issued by the European Union, under the trade pact, around 90 per cent of medical device —Optical, medical and surgical equipments— imported from the 27-nation bloc, previously subject to duties up to 27 per cent, will become duty face zero per cent duty (tariffs) in India.
While the Commerce Ministry is yet to release the full text of the trade pact, Pavan Choudary, Chairman, of MNC body MTaI, said that “if the fine print aligns with the announcements, the FTA will help improve affordability and access to advanced therapies.”
“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,” Choudary added.
Speaking for domestic firms, Rajiv Nath, Forum Coordinator, AiMeD said, “With fair regulatory alignment and safeguards against predatory imports, especially from 3rd countries, this agreement can unlock high‑value collaboration, boost domestic manufacturing, and support India’s ambition to become a top‑five global MedTech hub.
Stressing on aligning the regulatory norms to address the non-tariffs barriers, Nath added, “the goal should be mutual growth anchored in quality, transparency, and under a MRA(mutual recognition agreement) based on common ISO standards.”
Notably, while the entire EU allows imports of medical devices at negligible tariff rates, domestic firms in India have cited concerns over the divergent regulatory framework, has led to steep compliance costs, deterring emerging domestic exporters from tapping this key market.
Besides this another major factor contributing to India’s import reliance in the medical device sector is the limited manufacturing capability for high-end, technology-intensive equipments.
However, Choudary expects the FDA to act as an import substitutive pact that will enable India to strengthen its innovation ecosystem by partnering with global giants while expanding exports of medical textiles, surgical instruments and disposables.
As per trade think tanks, in 2024 India exported around $580 million worth of medical devices, largely consumables, meanwhile European exports shipped $1.13 billion worth of goods such as endoscopes, Linear ultrasound scanner etc.
