septembre 8, 2025

China Medtech: Summer 2025 Executive Briefing (en)

by vvr-auteur-1 in Actualités VVR Medical

China Medtech: Summer 2025 Executive Briefing

The summer of 2025 marked a pivotal period for China’s medtech sector, defined by a sharp escalation in geopolitical trade measures and a powerful, policy-driven push for domestic manufacturing. While a new EU-China procurement standoff creates immediate market access hurdles for importers, a resilient funding environment and a series of landmark domestic innovations signal the growing strength and sophistication of China’s local ecosystem.

 Key Developments at a Glance:

Policy & Regulatory: Geopolitical Tensions Force a Strategic Shift

    • On July 6, China retaliated against EU trade measures, banning EU-based firms from government tenders for high-value medical devices (e.g., MRI machines) valued over ¥45 million.
    • A critical exemption was made for products manufactured in China by EU-invested firms, creating a powerful incentive for foreign companies to localize production to maintain market access.
    • Domestically, the NMPA proposed longer, more predictable grace periods (2-3 years) for devices up-classified to a higher risk category, aiming to reduce compliance shocks for manufacturers.

Manufacturing & Logistics: « In China, for China » Becomes an Imperative

    • Global giants like Siemens Healthineers are doubling down on localization, with many high-end systems already produced on the mainland, mitigating the impact of the new procurement ban.
    • Germany’s Evonik opened its largest medical device application center in Shanghai, bolstering the domestic supply chain for advanced bioresorbable components.
    • The broader life sciences supply chain was fortified by over $48 billion in pharmaceutical investments in H1 2025, surpassing the total for all of 2024.

Clinical & Patients: Innovative Access Models Mature

    • The Hainan Boao Lecheng Pilot Zone has now introduced 485 advanced overseas medical products, treating over 130,000 patients.
    • In a landmark move, global insurer AXA partnered with the Hainan zone to develop commercial insurance plans covering these advanced therapies, signaling a new phase of commercial viability.
    • New clinical trials were registered for cutting-edge domestic technologies, including intravascular shockwave systems and noninvasive deep brain stimulation devices.

Innovation & IP: Domestic Champions Go Global

    • The NMPA granted approval to China’s first miniature spinal surgical robot, the « Intelligent SpinePecker » fast-tracked via the innovative device pathway.
    • Zai Lab and Novocure received NMPA approval for Optune, the first new treatment for glioblastoma in China in over 15 years.
    • In a sign of growing global ambition, Peijia Medical submitted a 510(k) application to the U.S. FDA for its DCwire® Micro Guidewire, directly targeting the American market.

Funding & Partnerships: Healthcare Bucks the « Venture Winter »

    • While overall venture funding in China fell 34% YoY in Q2, the healthcare sector remained resilient, with biopharma firms raising ~$481 million in July alone.
    • The Hong Kong Stock Exchange cemented its role as the world’s top healthcare fundraising hub, with 10 IPOs raising US$2.1 billion in H1 2025.

Sales & Markets: Procurement Rules Reshape the Playing Field

    • The EU procurement ban immediately disrupted sales channels for imported high-value equipment, creating a protected market for domestic and localized products.
    • H1 financial results from listed firms like Peijia Medical (revenue +17.3%) suggest a gradual market recovery from the 2024 slowdown.
    • China’s medical device exports remain a strong growth engine, with trade value showing a 9.4% compound annual growth rate over the past five years.