"Policy + Innovation" Dual Empowerment Drives Internationalization Breakthrough for China's Medical Device Industry

On October 21, the official website of the National Medical Products Administration (NMPA) reported that the "2025 Medical Device Economic Information Release Conference," hosted by the Southern Medical Economic Research Institute of the NMPA, was held in Hefei. The conference pointed out that the NMPA will further improve the legal and standard system, increase support for research and development innovation, enhance the quality and efficiency of review and approval, comprehensively strengthen the high-level safety bottom line of medical devices, accelerate the market entry of innovative products, and promote the high-quality development of the medical device industry.

On the same day, data released by Beijing Customs showed that in the first eight months of this year, Beijing's exports of medical instruments and equipment reached 5.83 billion yuan, a year-on-year increase of 21.5%. Analysts believe that the overseas market space for medical devices is several times larger than that in China, and an increasing number of medical device companies have achieved high growth in international business. Companies with recognized international capabilities have also seen a corresponding increase in their valuation.

　　Innovative Products Landing Intensively

Empowered by policies, innovation enthusiasm of China's medical device companies continues to rise, with multiple innovative products being approved and implemented intensively, becoming a direct reflection of the industry's innovative vitality.

Ningbo David Medical Device Co., Ltd. announced on the evening of October 21 that its wholly-owned subsidiary, Wellkedi, had recently received the medical device registration certificate for a disposable laparoscopic linear cutting stapler and components issued by the Zhejiang Provincial Drug Administration. The product is used for stump or incision closure in digestive tract reconstruction and organ removal surgeries under laparoscopy. Obtaining the medical device registration certificate for this product will help enrich the company's product line, further enhance its core competitiveness, and have a positive impact on the company’s future operating results.

On the same day, the official website of the National Medical Products Administration announced that recently, the National Medical Products Administration approved the innovative product registration application for "Extended Depth-of-Focus Intraocular Lens" by Tianjin Century Healthcare Biomedical Engineering Co., Ltd. This product is a single-piece posterior chamber intraocular lens, with an aspheric surface plus diffractive ring design on the front optical zone and a spherical surface on the back. It adopts a multi-order diffraction design to achieve extended depth-of-focus. It is suitable for vision correction in aphakic eyes after cataract removal surgery in adults, improving intermediate vision by extending the depth-of-focus to reduce dependence on glasses.

High-end medical imaging equipment, as an innovation hub, has recently seen several significant breakthroughs. In August this year, the National Medical Products Administration approved the innovative product registration application for the X-ray computed tomography (CT) equipment from Neusoft Medical Systems Co., Ltd. The product consists of a gantry, high-voltage generator, X-ray tube assembly, photon-counting detector, examination table, laser positioning light, control console, beam limiter, optional accessories, and attachments. It is mainly used for routine CT examinations and supports coronary CT angiography and spectral imaging. Compared with traditional CT, this product offers higher spatial resolution and can obtain multiple energy images in a single scan, better meeting clinical diagnostic imaging needs. In addition to Neusoft Medical Systems Co., Ltd.'s approval for its innovative medical device, Shanghai United Imaging's photon-counting CT has also been approved.

The concentrated emergence of corporate innovation achievements is inseparable from the precise support of regulatory policies. Recently, the National Medical Products Administration (NMPA) issued the "Announcement on Publishing Measures to Optimize Lifecycle Regulation and Support Innovation Development in High-End Medical Devices," promoting innovation in the high-end medical device field. The NMPA stated that photon-counting CT represents a major technological breakthrough in the CT imaging field over the past decade, significantly improving traditional CT imaging methods and demonstrating remarkable clinical application value. As a landmark product among high-end medical imaging equipment, the NMPA is providing full support for its market entry as required.

At the end of August this year, the National Medical Products Administration (NMPA) disclosed that in recent years, the NMPA has focused on key areas of new quality productive forces in medical devices such as medical robots, advanced medical imaging, artificial intelligence medical devices, and novel biomaterials, fully supporting the research and innovation of high-end medical devices.

　　Some Companies' Q3 Earnings Reports Are Impressive

Recently, some medical device companies have released their third-quarter reports. On the evening of October 20, Well Lead Medical released its Q3 2025 report. The company's revenue in the third quarter was 446 million yuan, representing a year-on-year increase of 16.09%. The net profit attributable to shareholders was 70.566 million yuan, marking a year-on-year growth of 16.31%. For the first three quarters, the revenue reached 1.191 billion yuan, increasing by 12.33% year-on-year, and the net profit attributable to shareholders was 192 million yuan, up by 14.94% year-on-year.

Weili Medical mainly engages in the research, development, production, and sales of medical devices in the fields of anesthesia, urology, nursing, respiratory care, and hemodialysis. According to the recent investor relations activity record released by Weili Medical, the company will continue to be market-oriented, closely follow clinical needs, increase R&D investment, accelerate the development of new products, and promote the rapid market launch of more innovative products. At the same time, it will expedite the construction of its overseas factory in Indonesia, actively advance the localization process in foreign markets, ensuring the continuous, stable, and healthy development of the company.

Chison Medical's main business is the research, development, manufacturing, and sales of ultrasound medical imaging equipment. The company's revenue in the first three quarters was 343 million yuan, a year-on-year decrease of 5.3%; the net profit attributable to shareholders was 93.92 million yuan, a year-on-year decrease of 4.6%. In particular, in the third quarter, the company achieved revenue of 107 million yuan, a year-on-year decrease of 6.68%; the net profit attributable to shareholders was 24.2241 million yuan, a year-on-year increase of 41.95%.

In addition to the companies that have already disclosed their third-quarter reports, some leading companies that have not yet released their reports also expressed optimistic expectations for their third-quarter performance. The investor relations activity record form recently released by Mindray Medical shows that the company expects its overall revenue in the third quarter of 2025 to achieve year-on-year positive growth, while continuing the trend of quarter-by-quarter revenue improvement. By region, the progress of international market business is generally in line with the company's expectations, and growth is expected to accelerate starting from the third quarter. With the ongoing in-depth construction of localized platforms, the proportion of international revenue in overall revenue will further increase, with emerging markets maintaining a rapid growth trend. Although the bidding for medical equipment in the domestic market began to recover in December last year, the cycle from public bidding to revenue recognition has been significantly extended. Therefore, the domestic market is expected to improve starting from the third quarter. Overall, the company will reach the turning point as expected in the third quarter.

　　Actively Expanding Globalization

CSC Financial believes that as the competitiveness of domestically produced medical device enterprises increases, the main growth logic of the medical device industry has gradually expanded to internationalization and technological innovation, leading to a revaluation.

In recent years, listed companies have been actively stepping up their internationalization efforts. Recently, Mindray Medical announced that in order to meet the needs of the company's business development, further advance its internationalization strategy, build an international capital operation platform, and enhance the company's capital strength, after thorough research and deliberation, the company plans to issue foreign-invested shares (H shares) overseas and list them on the Main Board of the Hong Kong Stock Exchange.

Mindray Medical's recently released investor relations activity record shows that the company has now risen to become one of the top 30 global medical device enterprises. The market share of multiple product lines ranks among the top three globally, with international business revenue accounting for nearly half. A solid foundation for its global business layout has been established. This application for listing on the Hong Kong stock exchange will deeply promote the strategic synergy between business globalization and capital globalization: On one hand, it will help the company more efficiently connect with overseas market resources, further enhancing its global influence and providing strong capital support for competing with international giants in the global market; on the other hand, relying on the international influence of the Hong Kong market, it will clearly communicate the company’s positioning and investment value as a "globally leading, innovation-driven world-class medical device enterprise and leader in digital and intelligent healthcare" to global investors, significantly improving the company's brand awareness and influence in the international capital markets and the global medical device industry.

Weili Medical is also actively promoting the establishment of factories overseas. The company recently disclosed that its Indonesian factory is currently in the construction and pre-certification stage for products, with gradual shipments expected to begin by the end of the first quarter of 2026. The first phase of production capacity at the Indonesian factory will mainly supply major U.S. clients, focusing on the production of catheters and suction connection tubes, with the possibility of adding anesthesia products based on market demand. After the official launch of the Indonesian factory, it is expected to significantly boost the growth of the company’s export orders.

CSC Financial believes that, in terms of growth momentum, the international business space is broader. Currently, the overseas operations of multiple device companies are experiencing high growth, and in the future, the proportion of international business will exceed that of domestic business. Some innovative medical device products have already achieved a leap from imitation to leading globally and are gradually making their mark internationally. In addition, mergers and acquisitions are an important growth path for leading international device companies, and more industry M&A cases will emerge in the future.