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China's Medical Device Exports: Current Situation, Challenges and Opportunities

#Company news ·2024-10-01 11:40:58

In recent years, China's medical device industry has developed rapidly, and its export scale has been continuously expanding. In 2024, China's exported medical equipment covered more than 9,000 medical institutions in over 190 countries and regions, demonstrating the growing prominence of domestic medical devices in the global market. According to the statistics of the China Chamber of Commerce for Import and Export of Medicines and Health Products, in the first three quarters of 2024, the import and export volume of China's medical devices reached $62.19 billion, a year - on - year increase of 0.1%. Exports showed a return to a healthy and stable growth trend, with the growth rate accelerating gradually, and are expected to maintain a good growth momentum throughout the year.

In terms of the export product structure, the product categories are rich and each has its own highlights. In the first three quarters of 2024, the export volume of disposable consumables reached \(7.6 billion, a year - on - year increase of 10.64%. The export of glove - type products fully recovered its prosperity, with a significant growth rate. The export volume of health care and rehabilitation products was \)7.238 billion, a year - on - year increase of 3.9%, with massage appliances accounting for 47.7% of the exports. The export volume of dental equipment and materials was \(1.553 billion, a year - on - year increase of 7.12%. The export volume of hospital diagnosis and treatment products was \)16.013 billion, a year - on - year increase of 3.2%, among which the export volume of products such as endoscopes, nuclear magnetic resonance, and in - vitro diagnostic reagents increased significantly. However, the export volume of medical dressings was $2.935 billion, a year - on - year decrease of 3.36%. This indicates that there are different development trends in different sub - fields of China's medical device exports. Some traditional products are facing adjustments, while innovative and high - tech products are gradually opening up the international market.

In terms of the distribution of export markets, the United States remains the largest export destination for China's medical devices. In the first three quarters of 2024, the amount of medical devices exported from China to the United States increased by 7.3% year - on - year. The year - on - year growth rates of the export volume of dental equipment and materials, medical dressings, and disposable consumables all exceeded double digits. Japan, as the second - largest export destination, has a stable market share. At the same time, the export of China's medical devices to the EU has been continuously picking up. In the first three quarters of 2024, the amount of medical devices exported to the 27 EU countries was \(6.58 billion, a year - on - year increase of 9.4%. The exports to the Netherlands, France, Italy and many other countries achieved double - digit year - on - year growth. In addition, the export performance to the Belt and Road Initiative countries is also remarkable. In the first three quarters of 2024, the cumulative export was \)13.44 billion, a year - on - year increase of 5.1%, with significant growth rates in exports to markets such as Venezuela, Iraq, and the United Arab Emirates. The diversified market layout provides a broad space for the export of China's medical devices and reduces dependence on a single market.

Despite remarkable achievements, the export of China's medical devices also faces many challenges. In terms of international trade policies, trade protectionism has shown signs of resurgence. On June 20, 2025, the EU, based on the "International Procurement Instrument" (IPI), decided to restrict Chinese companies from participating in medical device tenders worth over 5 million euros, which hinders Chinese medical device companies from entering some high - end projects in the EU market. At the same time, the access standards and regulations for medical devices in some countries are constantly being tightened. For example, the US FDA has strict requirements for the quality system and registration of imported medical devices. In the first three quarters of 2024, the US FDA notified a total of 7,400 batches of rejected imported medical products, a year - on - year increase of 48.5%, among which 2,175 batches of Chinese medical products were rejected, a year - on - year increase of 289.8%, mainly involving products such as piston syringes and medical examination gloves. The main reasons for rejection are that the processing process does not meet the requirements of Good Manufacturing Practice (GMP) and registration issues. This poses higher challenges to the product quality control and regulatory compliance capabilities of Chinese medical device companies.

From the perspective of enterprises themselves, although there are a large number of Chinese medical device companies, most of them are small - scale, with limited R & D investment, serious product homogenization, and weak brand influence in the international market. Compared with established medical device companies in Europe and the United States, Chinese companies lag in high - end product R & D, global marketing network construction, and improvement of after - sales service systems, and it is difficult to gain an advantage in international high - end market competition.

Facing these challenges, Chinese medical device companies are actively exploring countermeasures. On the one hand, they increase R & D and innovation investment to improve product quality and technological content. National and local government departments have also actively introduced relevant policies to support the innovation and international development of medical device companies, such as opening up a green channel for the priority inspection of innovative drugs and medical devices, and implementing on - the - spot inspection for clinically urgently needed drugs and medical devices. More and more companies are beginning to focus on independent R & D, and breakthroughs have been made in some high - end medical device fields. Innovative products are constantly being launched in fields such as new biomaterial medical devices, high - end medical imaging equipment, and medical robots, enhancing the competitiveness of products in the international market.

On the other hand, the localization strategy is being promoted. Just as "GPS" (General Electric, Philips, Siemens) took root in China back then, Chinese companies are now taking the initiative to lay out local production supply chains in target markets and integrate into the local ecosystem. Mindray Medical has entered 70% of Indian medical institutions, with local Indian employees accounting for 95%, and has established 21 subsidiaries in 15 countries along the Belt and Road Initiative. In addition to its existing production bases in Shanghai, Changzhou, Wuhan, and Houston in the United States, United Imaging plans to strengthen its production network layout in regions such as Southeast Asia, Latin America, and Europe. Through local production, it can better meet local market demands, avoid trade barriers, and enhance brand image.

Looking to the future, the prospects for the export of China's medical devices remain broad. With the intensification of the global aging population, the continuous growth of medical demand, and the expansion of the medical device market year by year, it provides a broad market space for Chinese medical device companies. At the same time, driven by innovative technologies, the domestic production rate of China's medical device industry is constantly increasing, and a scale advantage has been formed in some fields, and its international competitiveness will continue to increase. In the future, Chinese medical device companies need to continue to adhere to innovation - driven development, improve product quality and brand influence, optimize the global market layout, and strengthen local operations to respond to the ever - changing international market environment and occupy a more important position in the global medical device market.

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