Indian medical device manufacturers are spotting a strategic opportunity to replace Chinese suppliers and expand their presence in the lucrative US market. However, several companies are facing challenges in scaling up quickly and navigating complex regulatory procedures in the United States.
US-China Trade War Creates an Opening
The ongoing tariff war between the United States and China, initiated during the Trump administration, has extended to nearly all Chinese goods—including medical devices. This has significantly reduced China’s cost advantage, presenting a window of opportunity for Indian manufacturers.
Recognizing this shift, many Indian companies have begun preparing regulatory filings and documentation to avoid missing out on this evolving business landscape.
Syringe Exports Could Surge
“China exports a large volume of syringes to the US at low prices. With tariffs now in place, we see a real opportunity,” said Rajiv Nath, Managing Director of Hindustan Syringes & Medical Devices Ltd (HMD) and Forum Coordinator of the Association of Indian Medical Device Industry (AIMED).
HMD, a global leader in syringe production, also exports surgical blades to the US and already holds 510(k) clearance from the USFDA for syringes. Due to market conditions, the company had paused exports but is now considering reviving its 510(k) submission to re-enter the US syringe market.
Diversifying Product Offerings
Dr. GSK Velu, Chairman and Managing Director of Trivitron Healthcare, noted that the global trade environment is shifting and expects clarity within 3–6 months. He added that the tariffs could boost the radiation protection segment, with rising demand from US healthcare providers.
Trivitron had earlier acquired US-based The Kennedy Company, which manufactures radiation protection equipment like aprons, shields, gloves, and eyewear used in diagnostic and nuclear medicine settings.
India’s Potential as a Global Supplier
Industry experts believe India is well-positioned to become a cost-effective alternative to China for products such as disposables, consumables, IVD reagents, and basic surgical instruments. Companies like Poly Medicure already have strong export operations. However, India still relies heavily on imports for high-end and tech-intensive devices.
US Market: A Key Export Destination
As reported by moneycontrol, The United States remains India’s top export market for medical devices, gaining further traction after the COVID-19 pandemic. In FY24, India exported medical devices worth ₹5,667 crore (approximately $700 million). The exports consisted primarily of:
- Electronic equipment (46%)
- Consumables (34%)
- Disposables (7%)
- Implants (7%)
- IVD reagents and surgical instruments (remaining share)
Still, India’s exports are dwarfed by China, which shipped over $14 billion worth of medical equipment to the US in 2023, with some estimates placing the total closer to $20 billion.
Regulatory Hurdles Remain
Despite the opportunity, Indian manufacturers face steep non-tariff barriers in the US. High filing costs, prolonged approval timelines, and stringent regulatory requirements make market entry difficult.
For instance, registering a basic product like a bandage costs ₹8 lakh and takes about a month. More complex devices such as catheters, infusion pumps, and pulse oximeters cost between ₹14–29 lakh and require 9–24 months for approval. High-risk products like cardiac stents, ventilators, and valves can cost up to ₹4.5 crore and may take up to 30 months to get approved.
Strategic Acquisitions and Partnerships
To bypass these hurdles, Indian companies are increasingly turning to global acquisitions and joint ventures. For example, Zydus Lifesciences recently acquired French orthopedic implant maker Amplitude Surgical in a ₹2,400 crore deal. Similarly, Meril Life Sciences acquired US-based Maxx Medical to strengthen its footprint in orthopedic devices.
Component Supply Still a Bottleneck
Another major challenge lies in the lack of a robust component manufacturing ecosystem in India. Medical devices often require critical parts like semiconductor chips, sensors, displays, and actuators—components in which China dominates.
“It’s not possible to build a component manufacturing ecosystem unless we produce finished products first,” Rajiv Nath emphasized.
Caution Over China’s Countermeasures
Indian manufacturers are also concerned that China may respond by devaluing the yuan to regain competitiveness or reroute its exports to the US through third countries.
The Road Ahead
While India stands on the brink of a significant export opportunity, realizing its full potential will require investment, regulatory reform, strategic partnerships, and stronger local component manufacturing. If these challenges are addressed, Indian manufacturers could play a much larger role in the global medical device supply chain.