New trade framework cuts tariffs, to ease market delays for US medical devices

Medical devices

• US-India trade deal cuts medical device tariffs from 50 percent to 18 percent
• India to decide on accepting US or global testing standards within six months
• Indian medtech industry seeks reciprocal fairness for exports to US market

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The US-India trade agreement will offer relief for medical devices exports, as the tariff will come down from 50 percent to 18 percent, in return it says India has agreed to dismantle long-standing non-tariff barriers that have historically frustrated US exporters.

The statement says India will decide within six months of the deal’s start whether to accept US or international testing standards for exports, potentially cutting months of delay for US medical devices to enter market.

"India agrees to address long-standing barriers to the trade in US medical devices; eliminate restrictive import licensing procedures that delay market access for, or impose quantitative restrictions on, US Information and Communication Technology (ICT) goods; and determine, with a view towards a positive outcome, within six months of entry into force of the Agreement whether US-developed or international standards, including testing requirements, are acceptable for the purposes of US exports entering the Indian market in identified sectors," the statement says.

Indian domestic medical device industry welcomed the deal, and sought "reciprocal fairness" when it comes to non-tariff barriers faced by them to enter US market.

“AiMeD welcomes the US-India joint statement on trade barriers and clarifies that CDSCO import licenses for US devices are already faster than for Indian manufacturers, who face mandatory inspections unlike overseas firms," said — Rajiv Nath, Forum Coordinator, AiMeD

The US leads imports at Rs.14,000 crore or 20 percent share, surpassing China's Rs.12,000 crore.

"With our US exports at $750 million versus $1.6 billion imports last year. US FDA's preference for ACSA over NABL labs adds asymmetry. Indian medtech battles Chinese dumping, EU CE delays, Japan's yen weakness, and Indonesia's biases, plus CDSCO hurdles. We urge reciprocal fairness, making trade mutually advantageous to empower both nations' innovations," Nath said.

"We see this as a strong opportunity for deeper technology collaboration, particularly in high-value segments such as medical imaging, where US companies have established strengths," said Himanshu Baid, Managing Director, Poly Medicure Ltd.

"With US import tariffs on Indian medical devices at 18%, Indian MedTech exporters gain a meaningful competitive advantage in one of the world’s most sophisticated healthcare markets. This agreement will further empower MSMEs, deepen India-US economic engagement, and create long-term opportunities for innovation-led growth. The US continues to be a key and growing market for Polymed, aligned with its global expansion strategy," Baid added.