India's medical device manufacturing sector is undergoing a pivotal moment. With the US-China trade war intensifying and tariffs eroding China’s pricing advantage, Indian manufacturers are sensing a golden opportunity to step in and expand their footprint in the lucrative US medical device market. However, they also face several regulatory and scalability challenges that need urgent attention.

The Opportunity: US-China Tariffs Create Market Gap

The ongoing tariff war between the US and China—a legacy of the Trump-era trade policies—has now extended to include medical devices. This has significantly weakened China’s ability to offer low-cost exports to the US, a space where it once held dominance. Indian firms, known for their cost-effective manufacturing and growing technological capabilities, see this as a chance to fill the void.

According to Rajiv Nath, Managing Director of Hindustan Syringes & Medical Devices Ltd (HMD) and Forum Coordinator of AIMED (Association of Indian Medical Device Industry), Indian firms are working on regulatory paperwork to avoid missing the window of opportunity created by the tariffs.

“China does a lot of syringe exports to the US at lower prices. With the tariffs in place, we have an opportunity,” Nath stated in a recent interview.

HMD already has USFDA 510(k) approval for its syringes and exports surgical blades to the US. However, due to earlier market constraints, it couldn’t scale up exports. Now, the company is looking to revive its US operations, signaling India’s intent to gain ground.

Export Potential and India's Current Position

The United States is already India's largest medical device export market, and recent years have seen rising momentum, especially after the pandemic. In FY24, India exported ₹5,667 crore (approximately $700 million) worth of medical devices. This included:

• Electronic equipment: 46% share

• Consumables: 34%

• Disposables and Implants: 7% each

• IVD reagents and surgical instruments: Remaining portion

However, India's exports pale in comparison to China, which exported $14.05 billion worth of medical equipment to the US in 2023. Some estimates suggest China's total exports were closer to $20 billion.

While Indian firms like Poly Medicure already enjoy a strong global export base, high-end medical technologies are still largely dependent on imported components—something China dominates.

Barriers to Entry: High Costs and Complex Regulations

Despite the optimism, Indian medical device manufacturers are facing steep hurdles when it comes to entering and scaling in the US market. Key challenges include:

1. Regulatory Approvals are Expensive and Time-Consuming

Firms must navigate complex regulatory processes, including obtaining USFDA 510(k) clearances, which are both costly and slow.

• Basic bandage registration: Approx. ₹8 lakh and 1-month timeline

• Pulse oximeters, catheters, infusion pumps: ₹14–29 lakh, 9–24 months

• High-risk products like cardiac stents and ventilators: ₹1 crore to ₹4.5 crore, 18–30 months

These numbers, shared by Rajiv Nath, highlight why many Indian firms struggle to scale fast in this competitive landscape.

2. Component Manufacturing Gaps

India does not yet have a strong ecosystem for manufacturing key components like semiconductor chips, actuators, sensors, and displays. These are essential for modern medical devices. China, on the other hand, is a critical part of the global supply chain, giving it a structural edge.

“It's not possible to build component manufacturing eco-system, if we don't make finished products,” Nath emphasized.

Strategic Moves: Mergers, Acquisitions, and Global Collaborations

To navigate the complexities of market entry and bridge technology gaps, Indian companies are increasingly turning to acquisitions and partnerships with foreign firms.

• Trivitron Healthcare, led by Dr GSK Velu, had previously acquired The Kennedy Company in the US, which manufactures radiation protection gear like aprons, gloves, and shields. The firm expects the current tariffs to benefit their radiation protection business as US buyers look for alternative suppliers.

• Zydus Lifesciences recently bought France-based orthopedic implant maker Amplitude Surgical for over ₹2,400 crore (€256.8 million), marking a major step in global expansion.

• Meril Life Sciences acquired Maxx Medical, a US-based orthopedic devices company, to gain a foothold in the American market and access sophisticated technology and distribution networks.

These acquisitions not only give Indian firms market access but also help them leapfrog technology and regulatory barriers.

Concerns Over Chinese Countermeasures

While India looks to capitalize on the current situation, manufacturers are also wary of Chinese counterstrategies such as:

• Devaluation of the Chinese yuan to regain price competitiveness

• Re-routing exports through third-party countries to bypass US tariffs

Both these tactics could undermine the competitive advantage that Indian companies currently hope to leverage.

What Lies Ahead: Opportunity vs Challenge

The global landscape is shifting, and India’s medical device industry is at a crossroads. With the US market offering unparalleled potential, Indian companies have a chance to become a reliable, cost-effective, and scalable alternative to China.

However, realizing this opportunity will require:

• Government support for easing regulatory hurdles

• Policy incentives to build component manufacturing capacity

• More public-private partnerships and global acquisitions

• Speeding up approval processes through international collaboration

India’s Medical Devices Policy 2023, which aims to boost innovation, manufacturing, and investment, could play a key role in shaping the next phase of growth.

Conclusion: A Defining Moment for Indian Medical Devices Sector

India’s quest to become a global medical device hub is no longer aspirational—it’s increasingly becoming a strategic necessity. The US-China tariff war has cracked open a massive window of opportunity. But only those prepared with scale, compliance, and capability will succeed in seizing it.

If Indian companies can overcome the current bottlenecks, the country could transition from being a marginal player to a major global supplier, especially in low-cost, high-volume devices like syringes, gloves, and consumables.

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