SHANGHAI, Feb. 1 (Global Times) – Chinese medical device enterprises are accelerating their global expansion pace, leveraging technological innovation and targeted regional cooperation to tap into emerging markets, with exports of high-value products and cross-border partnerships driving a new wave of growth, industry reports and enterprise announcements revealed on Thursday.
Against the backdrop of recovering global demand for medical supplies and rising demand for cost-effective innovative medical solutions, China’s medical device exports continued to show strong resilience. Preliminary data for the fourth quarter of 2025 indicates that exports in the period reached 13.8 billion US dollars, a 4.2% quarter-on-quarter increase, with full-year 2025 exports expected to slightly exceed the previously estimated 50.5 billion US dollars, according to the China Association for Medical Devices Industry (CAMDI).
Unlike previous growth driven by low-cost consumables, this round of expansion is led by high-end medical devices and personalized medical solutions. Domestic enterprises have made significant breakthroughs in fields such as in vitro diagnostics (IVD), minimally invasive interventional devices, and medical imaging equipment. For instance, a leading Chinese medical device firm recently secured CE certification for its new generation of cardiac stents in the European Union, marking the first time a domestic product in this category has met the EU’s strict medical device regulation (MDR) standards.
Emerging markets have become a key growth engine for Chinese medical device exports. In 2025, exports to Southeast Asia, Central Asia, and Latin America increased by 7.8%, 9.3%, and 6.5% year-on-year respectively, outpacing the overall export growth rate. The Regional Comprehensive Economic Partnership (RCEP) has played a crucial role in reducing trade barriers: tariff reductions under the agreement have helped Chinese medical devices gain price advantages in member countries, with exports to RCEP economies accounting for 38% of total medical device exports last year.
Cross-border joint research and production cooperation have also become a new trend. Several Chinese enterprises have established R&D centers and production bases in Southeast Asia and Eastern Europe, integrating local resources to adapt to regional market needs. A Shanghai-based IVD company announced a joint venture with a Thai medical firm in January 2026 to produce rapid diagnostic kits tailored to tropical diseases, which is expected to enter mass production in the second quarter.
Regulatory compliance and international certification have become priorities for domestic enterprises seeking global expansion. In 2025, more than 120 Chinese medical devices obtained FDA approval in the United States, and over 180 received CE certification in the EU, a year-on-year increase of 15% and 22% respectively. The Chinese government has also strengthened support for enterprises’ international certification, providing subsidies and professional guidance to help small and medium-sized enterprises overcome technical and regulatory hurdles.
Industry experts pointed out that China’s medical device industry is entering a critical period of transformation from "scale expansion" to "quality improvement". "With continuous investment in R&D and deepening regional cooperation, Chinese medical devices are gradually gaining recognition in the global high-end market," said Li Wei, a senior analyst at CAMDI. "However, enterprises still need to address issues such as intellectual property protection and brand building to enhance long-term competitiveness."
Looking ahead, the launch of several international medical device exhibitions and trading platforms in 2026 is expected to further boost cross-border exchanges. The China International Medical Devices Expo (CMEF) will hold a special exhibition in Dubai in March, focusing on promoting Chinese innovative medical devices to the Middle East and African markets.