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

Source: China Securities Journal

Xinhua Finance, Beijing, October 22nd, by reporter Fu Su Ying — On October 21st, the official website of the National Medical Products Administration (NMPA) announced 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 reinforce 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 valuations.

Innovative Products密集Landing

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

David MedicalAnnouncement on the evening of October 21: Recently, our wholly-owned subsidiary Wellkedi received the medical device registration certificate for its disposable laparoscopic linear cutting stapler and components from the Zhejiang Provincial Drug Administration. This product is used for closing the stump or incision during laparoscopic gastrointestinal reconstruction and organ resection surgeries. 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 has approved Tianjin Century Healthcare.BioTech HealthcareTianjin Century Healthcare Biomedical Engineering Co., Ltd. "Extended Depth-of-Focus Intraocular Lens" Innovative Product Registration Application. This product is a single-piece posterior chamber intraocular lens, with an aspheric anterior optical zone surface featuring a diffractive ring design and a spherical posterior surface. It employs multiple diffraction orders to achieve extended depth-of-focus. It is suitable for vision correction in aphakic eyes following cataract removal surgery in adults, reducing dependence on glasses by improving intermediate vision through extended depth-of-focus.

High-end medical imaging equipment, as an innovation hub, has recently witnessed 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, console, beam limiter, optional components, and accessories. 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 imaging diagnostic needs. Reportedly, apart from Neusoft Medical Systems Co., Ltd.,Innovative HealthcareIn addition to the device approval, 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 fully supporting its market entry in accordance with relevant requirements.

At the end of August this year, the National Medical Products Administration (NMPA) disclosed that in recent years, the NMPA has focused on medicalRobot, high-end medical imaging, artificial intelligence medical devices, and new biomaterials, and other key areas of new productive forces in the medical device industry, fully supporting the R&D 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.Virtue MedicalReleased on the evening of October 20, the company's Q3 2025 earnings report shows: Revenue for the third quarter was 446 million yuan, a year-on-year increase of 16.09%; Net profit attributable to shareholders was 70.566 million yuan, a year-on-year increase of 16.31%. For the first three quarters, revenue was 1.191 billion yuan, a year-on-year increase of 12.33%; Net profit attributable to shareholders was 192 million yuan, a year-on-year increase of 14.94%.

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 recently released record of investor relations activities, Weili Medical will continue to be market-oriented, closely align with clinical needs, increase R&D investment, accelerate the development of new products, and promote the rapid market entry of more innovative products. At the same time, the company will expedite the construction of its overseas factory in Indonesia, actively advance the localization process abroad, and ensure the continuous, stable, and healthy development of the company.

SonoScape MedicalThe main business is the research, development, manufacturing, and sales of ultrasound medical imaging equipment. The company's revenue for 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 disclosed their third-quarter reports, some leading companies that have not yet released their reports also expressed optimistic expectations for their third-quarter performance.MindrayThe recently released investor relations activity record shows that the company expects its overall operating 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 operations is generally in line with the company’s expectations, and growth is expected to accelerate starting from the third quarter. With the ongoing development of localized platform construction, the proportion of international revenue in the total revenue will further increase, with emerging markets maintaining a rapid growth trend. Although the domestic medical device bidding in China began to recover in December last year, the cycle from public bidding to revenue recognition has been significantly extended. Therefore, improvements in the domestic market are expected to begin in the third quarter. Overall, the company is set to reach an inflection point in the third quarter as scheduled.

Actively Expanding Internationalization

CSC FinancialIt is believed that with the enhancement of the product competitiveness of domestically produced medical device enterprises, 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, create an international capital operation platform, and enhance the company's capital strength, after thorough research and deliberation, the company plans to issue foreign 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. Its market share in multiple product lines ranks among the top three globally, with nearly half of its revenue coming from international business. A solid foundation for its global business layout has been established. The 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, the company will clearly communicate its positioning and investment value as a "globally leading, innovation-driven world-class medical device enterprise and pioneer in digital and intelligent healthcare" to global investors, significantly improving its brand recognition and influence in the international capital market 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 early product certification stage, 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 operation 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 gaining prominence on the international stage. 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.

Editor: Luo Hao