Priyanka Tiwari
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The ongoing U.S.-China tariff war has opened a window of opportunity for Indian medical device manufacturers, who are now exploring ways to tap into the American market. With nearly all Chinese goods, including medical devices, falling under Trump-era tariffs, the cost advantage once held by Chinese exporters has weakened.
Indian companies are preparing regulatory documentation and filing with the U.S. Food and Drug Administration (USFDA) to gain market access. The aim is to step in as alternative suppliers, especially in categories where China has traditionally dominated.
Indian Firms Begin Positioning for Market Entry
Rajiv Nath, Managing Director of Hindustan Syringes & Medical Devices Ltd and Coordinator of the Association of Indian Medical Device Industry (AIMED), pointed out that China has historically supplied syringes to the U.S. at lower prices. With the tariff impact, Indian companies like his now see an opening. Nath's firm is considering reviving its 510(k) registration to resume syringe exports to the U.S.
Meanwhile, other firms like Trivitron, which acquired U.S.-based The Kennedy Company, are already strengthening their presence in the American market through acquisitions.
India’s Export Capabilities and Limitations
India exported medical devices worth ₹5,667 crore ($700 million) in FY24. The product categories include:
Electronic equipment (46%)
Consumables (34%)
Disposables (7%)
Implants (7%)
IVD reagents and surgical instruments (remainder)
However, this is a fraction compared to China’s $14.05 billion in medical exports to the U.S. in 2023. Estimates suggest the true figure could be closer to $20 billion.
Indian firms have strong export bases for consumables and disposables, but still rely on imports for high-tech medical equipment. Leading players such as Poly Medicure and Meril are expanding through both exports and acquisitions.
High Costs and Regulatory Barriers Hinder Entry
Penetrating the U.S. market involves considerable regulatory costs and time. For instance:
Basic devices (e.g., bandages): ₹8 lakh and ~1 month
Mid-range devices (e.g., syringes, catheters): ₹14–29 lakh and 9–24 months
High-risk devices (e.g., ventilators, cardiac stents): ₹1 crore–₹4.5 crore and 18–30 months
These figures pose significant barriers for many Indian firms, especially small and medium-sized enterprises.
Component Dependency Remains a Strategic Weakness
India’s limited capacity in manufacturing critical medical device components such as semiconductors, sensors, and actuators continues to pose challenges. China remains the dominant supplier in this space, giving it an edge in the global supply chain.
“It’s not possible to build a component manufacturing ecosystem if we don't also scale finished product manufacturing,” said Rajiv Nath.
Indian manufacturers are also concerned about currency devaluation tactics by China and possible re-routing of Chinese products through third countries to bypass tariffs.
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