Indian MedTech manufacturers are spotting an opening to replace Chinese suppliers and expand their footprint in the lucrative US market. However, some industry players are highlighting challenges related to scaling operations quickly and navigating complex regulatory pathways to gain market access in the US.
The ongoing trade tensions between the US and China — including the imposition of tariffs on nearly all Chinese goods, such as medical devices — have significantly reduced China’s price advantage. This shift has opened a window for Indian companies to step in. In response, several Indian MedTech firms are initiating the regulatory processes and filings needed to tap into this emerging opportunity.
“China has been a major exporter of syringes to the US at very competitive prices. With tariffs now in place, Indian manufacturers have a real chance,” said Rajiv Nath, Managing Director of Hindustan Syringes & Medical Devices Ltd (HMD) and Forum Coordinator for the Association of Indian Medical Device Industry (AIMED). HMD, one of the world’s leading syringe manufacturers, already exports surgical blades to the US and holds a 510(k) registration with the USFDA for syringes, though exports have been limited due to previous market conditions. Nath said the company is now considering reactivating its USFDA registration to begin exports.
Dr. GSK Velu, Chairman and MD of Trivitron Healthcare, another major Indian MedTech company, said that while the current global trade environment is shifting, it will take three to six months for a clearer picture to emerge. Velu noted that the tariffs could benefit their radiation protection segment, with expected growth in US orders. Trivitron had earlier acquired The Kennedy Company, a US-based manufacturer of radiation protection gear like aprons, shields, gloves, and eyewear used in medical imaging settings.
Industry experts believe India is well-positioned to become a reliable alternative to China for producing high-volume, lower-cost items such as consumables, disposables, select surgical tools, and IVD reagents. Companies like Poly Medicure have already built a strong export foundation. However, for more advanced, high-tech medical equipment, Indian manufacturers still depend heavily on imported components.
US – A Key Export Destination
The US remains India’s top export destination for medical devices, especially after the pandemic boosted demand. In FY24, India exported medical devices worth ₹5,667 crore (around $700 million), led by electronic equipment (46%), consumables (34%), disposables and implants (7% each), with the remainder comprising IVD reagents and surgical tools. Still, India’s export figures pale in comparison to China’s $14.05 billion in medical device exports to the US in 2023, with estimates suggesting actual figures could be closer to $20 billion.
Barriers to Entry
Despite the opportunity, Indian MedTech manufacturers point to several hurdles in entering the US market, including high regulatory costs, long approval timelines, and procedural complexity. Some devices may even require clinical trials, increasing both time and expenses.
Rajiv Nath noted that even registering a simple bandage can cost ₹8 lakh and take a month. For more complex items like catheters, pulse oximeters, and infusion pumps, the costs range between ₹14 lakh and ₹29 lakh, with approval timelines stretching from 9 to 24 months. High-risk devices such as cardiac stents, valves, and ventilators require even more time and investment—up to ₹4.5 crore and 30 months.
To overcome these challenges, Indian companies are increasingly seeking international partnerships and acquisitions. For example, Zydus Lifesciences recently acquired France-based Amplitude Surgical in a deal worth over ₹2,400 crore, while Meril Life Sciences acquired US-based orthopedic device maker Maxx Medical.
Another limitation is India’s lack of a strong domestic component manufacturing ecosystem. Key parts like semiconductor chips, sensors, actuators, and display units are largely imported, with China dominating this segment. As Rajiv Nath puts it, “We can’t build a component ecosystem unless we manufacture finished products at scale.”
Indian firms are also wary of China’s potential to devalue the yuan to stay price-competitive or reroute its exports to the US via third-party countries, which could dampen India’s efforts to grow its market share.
