Setting Sail in the Global Expansion Season: Release of 2022 Innovative Medical Device Going-Global Cases
As “innovation” has become an instinct ingrained in the DNA of corporate growth, and as “domestic substitution” is gradually being realized across key niche sectors, expanding overseas operations and establishing a global footprint have clearly emerged as the new mission for local medical device enterprises in the new era. On the world map of the fiercely competitive medical device industry, Chinese companies are increasingly visible in many high-ground markets of international competition.
“Going Global”: A New Perspective on Observing the Development of Medical Device Companies
In 2021, as pandemic control became normalized, China’s medical device export trade data declined compared to 2020, with export value reaching $87.429 billion, a year-on-year decrease of 31.54%. Nevertheless, new trends emerged in terms of product categories, expansion models, and target markets for overseas expansion. By analyzing trade data and examining practical case studies of Chinese medical device companies going global, we aim to portray the innovative forces within this wave of internationalization from a multidimensional industrial perspective, seeking insights that resonate with the current context.
Based on this, VCBeat, VB100, and Eggshell Research Institute jointly launched in July 2022“2022 Call for Innovative Case Studies of Chinese Medical Device Companies Going Global”, the call for submissions and selection is open to innovative medical device companies in China with overseas market layouts, as well as service providers supporting medical device global expansion. This case study collection and selection is based on the ecosystem of medical device global expansion, fromGlobal Product Innovation, Global Strategic Layout, Global Enablement ServicesEvaluations were conducted from three perspectives, focusing on the innovations, standout advantages, achievements, role divisions and contributions of all participating parties, as well as the significance of the overseas expansion cases submitted by candidate organizations within the review year. Over a two-month period, 20 innovative cases emerged through rigorous screening. The final selection yielded“Best Innovative Product Case for Medical Device Global Expansion in 2022,” “Best Strategic Layout Case for Medical Device Global Expansion in 2022,” and “Best Service Empowerment Case for Medical Device Global Expansion in 2022”。
On September 16–17, 2022, the China Medical Device Global Expansion Conference was held in Beijing. In conjunction with this premier event for the internationalization of medical devices, the Organizing Committee released the 2022 Innovative Case Studies in Medical Device Global Expansion at the opening ceremony of the summit on September 16. Representatives from the award-winning companies were invited to attend the awards ceremony and participate in interactive sessions.
Innovative Case Release
Introduction to the Best Enabling Cases for Medical Device Companies Going Global in 2022
Company Abbreviation:PureCert
Award-Winning Case Name:EU CE Certification (IVDD List A) Full-Process Consulting Services
Selection Recommendation:
PureReg is an industry-leading global SaaS+Data life sciences service provider, dedicated to enabling end-to-end digitalization for medical device market expansion worldwide. It offers comprehensive consulting services for global regulatory compliance and market access for medical devices, in vitro diagnostics (IVD), and AI-based medical software products. Its services encompass regulatory consulting, local authorized representation, product certification and registration, overseas clinical trials, technical documentation and quality management system guidance, and product testing.
PureReg’s global service network spans numerous countries and regions worldwide. Its overseas clinical centers in Europe and the United States possess exclusive clinical resources that are scarce within the industry. By leveraging next-generation information technologies to digitally empower healthcare and collect big data, PureReg has established GRIP, a globally unique intelligent regulatory platform. This platform provides users with access to market entry requirements for over 100 countries, information on more than 600,000 global distributors, over 1 million clinical records, and details of more than 3 million global medical device registrations. It comprehensively empowers global market access for medical device products, disrupts the traditional medical device CRO model, and facilitates the global expansion of high-quality Chinese medical device products.
Company Abbreviation:Haihe Biologics
Award-Winning Case Name:Haihe Biologics Helps Yizhiying Secure FDA 510(k) Clearance for “AI Software for Automatic Delineation of Radiotherapy Target Volumes and Organs at Risk” with Zero Deficiencies
Selected Recommendation:
Haihe Biopharmaceutical Technology Group (hereinafter referred to as “Haihe Bio”) is a company that provides full lifecycle services for the research, development, and manufacturing of medical devices and pharmaceuticals, holding a prominent position in the industry. Its subsidiary, Haihe Biaoce, is a medical device testing center in China accredited with national-level CMA, CNAS, ANAB, U.S. FDA GLP, and OECD GLP certifications. It offers multiple domestically exclusive and internationally leading testing services, truly enabling “one test, global acceptance.” The team is well-versed in regulatory requirements across various countries, specializing in NMPA registration and filing in China, FDA submissions in the United States, CE certification in the European Union, UKCA certification in the United Kingdom, product registrations in Russia and CIS countries, as well as registrations with Brazil’s ANVISA and Health Canada. To date, it has successfully completed over 1,000 regulatory registrations and certifications worldwide. Tailored global market access strategic plans can be developed based on clients’ market development strategies and product characteristics, facilitating earlier product launches and sales.
RT-Mind-AI, an artificial intelligence software independently developed by Yizhiying Technology Co., Ltd. for the fully automatic delineation of radiotherapy target volumes and organs at risk, has developed clinical target volume (CTV) delineation capabilities for high-incidence cancers, including breast cancer, rectal cancer, cervical cancer, and esophageal cancer, as well as delineation products for over one hundred organs at risk throughout the body. This solution effectively assists clinicians across different regions and healthcare tiers in improving treatment efficiency, promoting the standardization of care quality, and enhancing patient survival rates.
Haihe Biologics fully recognizes the critical importance of this project to Yizhiying Technology Co., Ltd.’s global market expansion strategy and to the treatment of cancer patients overseas. Through in-depth communication, thorough preparation, dedicated service, and precise regulatory submission, we secured FDA 510(k) clearance in just 78 days with zero requests for additional information, thereby empowering our corporate client to rapidly advance its global strategic layout.
Company Abbreviation:Meiyin
Award-Winning Case Name:Medrhein’s Comprehensive Global Expansion Services
Selection Recommendation:
Meideyin is a full-process service provider that leverages digitalization to facilitate the entry of medical device manufacturers into the German-speaking market. By establishing a comprehensive and dense network of sales channels—including pharmacies, clinics, and testing centers—across various German states, Meideyin utilizes digital data mining and analysis to accurately identify market demands in the German-speaking region. The company assists Chinese manufacturers in applying for relevant legal certifications and, following product localization and packaging, strategically promotes these products to the local healthcare market through its digital platform and sales team, thereby extending brand influence to multiple European Union countries.
Meideyin’s strengths lie in its profound understanding of the European market, particularly the German-speaking regions, and its meticulously developed end-to-end closed-loop service system. Over the past year, Meideyin has served approximately 50 domestic medical device manufacturers, with antigen products imported into China reaching 150 million test kits. Its professional rapid COVID-19 antigen tests have achieved a 30% market share in Germany.
Case Studies on the Best Strategic Layouts for Medical Device Companies Going Global in 2022
Company Abbreviation:Berry Genomics
Award-Winning Case Name:Berry Genomics Comprehensive Analysis Technology for Thalassemia Alleles（Comprehensive analysis of thalassemia, CATSA）
Selection Recommendation:
Berry Genomics was established in May 2010 and listed on the Main Board of China’s A-share market in 2017 (Stock Code: 000710). The company is dedicated to the comprehensive translation of gene sequencing technologies into clinical applications, focusing on reproductive health, genetic disease testing, oncology testing, and scientific services. It has established R&D, production, marketing, sales, and customer service systems in accordance with international standards.
Berry Genomics’ Comprehensive Analysis of Thalassemia Alleles (CATSA) technology, developed based on third-generation sequencing platforms, offers an all-in-one solution for thalassemia testing. The assay is simple to perform, requiring only 1 µL of whole blood, with no need for DNA extraction or fragmentation, and achieves an accuracy rate of >99.9%. Both the third-generation sequencing platform and the third-generation thalassemia genetic testing kit have entered clinical trials. Upon formal approval, they are expected to further enhance the precision and efficiency of thalassemia prevention and control, significantly reducing societal costs associated with thalassemia management.
CATSA has obtained the patent certificate for “Method and Kit for Simultaneous Detection of Multiple Mutations in HBA1/2 and HBB Gene Loci,” published multiple academic papers, and completed several thalassemia screening projects, including the TiGA program. To date, it has tested over 100,000 samples, identifying numerous novel large-fragment deletions and structural variants.
In terms of product design, Berry Genomics’ CATSA was planned for global market entry from the outset. Its detection scope is not limited to the spectrum of thalassemia gene variants prevalent in the Chinese population; instead, it aims to cover all pathogenic thalassemia gene variants listed in authoritative databases. Meanwhile, the company has strived to expand compatible sample types, reduce the required initial sample volume, and enhance operational convenience, thereby improving the technical feasibility of large-scale clinical application from multiple perspectives and actively laying the groundwork for the international expansion of its medical devices.
Company Abbreviation:Hebai Biotech
Award-Winning Case Name:Hebai Bio's Overseas Strategic Layout for Its Products
Selection Recommendation:
Hebai Biotechnology Co., Ltd. was established in 2006 and is primarily engaged in the research and development, production, sales, and related services of point-of-care testing (POCT) instruments and reagents for the clinical in vitro diagnostics industry. The company has set up wholly-owned subsidiaries in Silicon Valley, USA, and Freiburg, Germany, serving as its reagent R&D center and process R&D center, respectively. Additionally, it has established branches in Taizhou, Jiangsu Province, and Nanshan District, Shenzhen, to serve as new industrial bases and R&D centers.
Hebai Biotech has successfully established its presence in overseas markets through a strategic combination of multi-platform, multi-methodology products:
Driven by the demand for high-precision, rapid, and portable liquid-phase detection in large-scale markets, Hebai Biotech has developed and exported an integrated sampler platform. As the core of Hebai Biotech’s proprietary “One-Step POCT” concept, the platform holds 21 granted patents. It effectively consolidates cumbersome procedures previously required in POCT devices, such as buffer transfer, sample transfer, and reagent transfer, thereby truly realizing a rapid, convenient, and accurate POCT solution.
To meet the demand for highly portable chromatographic testing in niche markets, Hepu Bio has developed and exported the Palm handheld immunofluorescence detection platform, enabling real-time testing with greater efficiency, flexibility, and environmental adaptability.
Based on the demand for home and personal testing, Hepure Biotechnology has developed and exported a single-use self-testing platform. Its user-friendly operation and human-centered design have enabled Hepure Biotechnology to successfully enter the consumer market for personal self-testing.
Hepu Bio has achieved numerous innovative milestones, with its main products including a fully automated testing platform and supporting diagnostic reagents for over 70 assays. The company’s products have successively obtained various internationally recognized certifications, including EU CE marking, US NGSP certification, US FDA 510(k) clearance and listing, and registration with the Dutch CIBG. Hepu Bio holds 130 granted patents, including 12 invention patents. Its products are exported to more than 80 countries across Europe, the Middle East, Southeast Asia, and other regions, and have been adopted by nearly 8,000 healthcare institutions worldwide to date.
Company Abbreviation:PUBO Medical
Award-Winning Case Name:Overseas Acquisitions Enhance Brand Influence; International OEM/ODM Collaborative R&D and Innovation
Selection Recommendation:
Pobo Medical is a national-level specialized, refined, distinctive, and innovative “Little Giant” enterprise. It focuses on the research, development, production, and sales of supporting solutions for key scenarios in emergency departments, operating rooms, and ICUs. The company provides multi-modal solutions encompassing equipment, consumables, and informatics, including ventilators, anesthesia machines, patient monitors, handheld color Doppler ultrasound systems, infusion pumps, critical care and perioperative consumables, and emergency/critical care information systems. Pobo Medical is committed to building a full-stack intelligent system for emergency and critical care treatment.
The company holds over 100 patents, and all its products have obtained NMPA approval and CE certification. It is one of the domestic manufacturers with the most diverse product portfolio in the industry, with products exported to more than 100 countries worldwide. Additionally, the company provides long-term technology exports, component supply, and OEM/ODM cooperation services to more than ten internationally renowned brands.
In November 2020, Pubo Medical completed the acquisition of Biosensors International’s Critical Care Division, known as Bioptimal Singapore, a renowned global brand specializing in high-value medical consumables. With 31 years of industry expertise, Bioptimal focuses on clinical settings such as operating rooms and ICUs, and holds significant market share in the United States, Singapore, and Japan. This acquisition not only fills the gap for domestic enterprises in high-end consumables for emergency and critical care but also establishes an innovative business model integrating equipment with consumables. Furthermore, leveraging the shared application scenarios, the global influence and marketing network of this international medical consumables brand will help expand and reinforce the parent company’s presence in overseas markets.
PUBO has actively responded to China’s Belt and Road Initiative, expanding its presence in Belt and Road countries and Latin America. The company participates in global tender projects organized by the United Nations and the World Health Organization, with its product series exported to West Asia, South Asia, Africa, Europe, and nearly 150 other countries and regions worldwide.
Company Abbreviation:Sinocare Inc.
Award-Winning Case Name:How Sinocare Achieves Localization in the Southeast Asian Market
Selection Recommendation:
“We aim to ensure that every diabetic patient in China has their own blood glucose meter.” Driven by this vision, Sinocare was officially founded in 2002, embarking on a mission to promote affordable blood glucose monitoring products and develop the domestic diabetes healthcare industry in China.
Over the past two decades, Sinocare has upheld its core value of “Promise for Love,” remaining dedicated to innovation in biosensor technology and engaging in the research and development, production, and sales of a series of rapid diagnostic testing products for patients with chronic diseases and healthcare professionals.
In 2016, Sinocare Inc. participated in the acquisitions of two U.S. companies, PTS and Trividia, respectively, actively expanding its point-of-care testing (POCT) business and establishing a leading position with the number one ranking in China and fifth globally in the diabetes blood glucose monitoring market.
As of 2022, Sinocare’s products were sold to over 135 countries and regions worldwide, with product registrations completed in 85 countries and regions. In 2021, its sales revenue reached RMB 115 million, and the company established subsidiaries in several Southeast Asian countries, including Vietnam and the Philippines.
Company Abbreviation:Vimai Medical
Award-Winning Case Name:Vimai Medical’s Global Dual-Center Strategic Layout
Selection Recommendation:
Beijing Weimai Medical Equipment Co., Ltd., a national-level “Specialized, Refined, Differential, and Innovative” (SRDI) Little Giant enterprise, is professionally dedicated to providing interventional diagnosis and treatment equipment and full-process solutions. With many years of experience in the research, development, design, and industrialization of digital vascular imaging products, its product portfolio covers multiple interventional product lines, including large-scale Digital Subtraction Angiography (DSA) systems, mobile X-ray C-arms, all-in-one mobile X-ray C-arm units, and interventional robots.
Weimai Medical closely follows the national “Belt and Road” strategic policy, completing the acquisition of Italy’s EC Company through various means such as overseas mergers and acquisitions, establishing dual global centers, and achieving an international strategic layout for product R&D, manufacturing, and marketing across “Belt and Road” countries in Asia, Africa, Southeast Asia, South Asia, West Asia, and East Asia.
Best Innovative Product Cases for Chinese Medical Device Companies Going Global in 2022
Company Abbreviation:Anhan Technology
Award-Winning Case Name:Anhan Technology’s Magnetically Controlled Capsule Endoscopy Product Goes Global
Award-Winning Product Images:
Selection Rationale:
Anhan Technology (Wuhan) Co., Ltd., established in 2009, is a high-tech enterprise dedicated to the research and development, manufacturing, sales, and services of innovative medical devices in the field of gastrointestinal health. As the pioneer and leader in magnetically controlled capsule gastroscopy technology, Anhan Technology holds more than 300 authorized patents domestically and internationally, with invention patents accounting for up to 40%. Leveraging its intelligent technology platform, the company has achieved a complete closed-loop system for the prevention, screening, diagnosis, treatment, and rehabilitation of gastrointestinal diseases.
Anhan’s “Magnet-Controlled Capsule Gastroscopy System” was introduced for clinical use in 2013 and became the first product in China to receive a Class III medical device registration certificate for a magnet-controlled capsule gastroscopy system issued by the NMPA. In 2020, the system obtained U.S. FDA De Novo classification for innovative medical devices, making it the world’s first and only capsule gastroscopy product to achieve De Novo clearance. Additionally, it has received CE marking in the European Union, MHRA certification in the United Kingdom, and TGA approval in Australia, among other certifications.
As a paradigm of medical-engineering integration, the magnetically controlled capsule gastroscopy system has achieved breakthrough active and precise magnetic control, with diagnostic accuracy for gastric diseases highly consistent with that of electronic gastroscopy. The AI-assisted image reading system significantly enhances the efficiency of interpreting physicians. This novel examination approach—characterized by being tube-free, precise, and comfortable—effectively addresses the pain points associated with traditional gastroscopy, namely patients’ fear, reluctance, or inability to undergo the procedure. It also offers solutions to the challenges of uneven distribution of medical resources and the shortage of digestive endoscopists. The clinical application of the magnetically controlled capsule gastroscopy system spans gastroenterology, health check-up centers, cardiology, geriatrics, pediatrics, and emergency departments. It has been widely adopted by nearly 1,000 medical institutions across 31 provinces, municipalities, and autonomous regions in China, and is exported to overseas markets including Europe and the United States.
Company Abbreviation:Haier Biomedical
Award-Winning Case Name:Global Innovation: -150°C “Deep Blue”! Haier Biomedical Ushers in a New Era of Ultra-Low Temperature Storage for Carbon Peaking and Carbon Neutrality
Award-Winning Product Images:
Selection Recommendation:
Haier Biomedical is a global manufacturer and supplier of comprehensive cold chain solutions. As an innovative digital scenario-based brand in the life sciences and healthcare sectors, it aims to deliver optimal user experiences. By independently developing and mastering core ultra-low temperature refrigeration technologies, Haier Biomedical has become the world’s only provider of biomedical low-temperature storage equipment covering the full temperature range from -196°C to 8°C. After nearly two decades of development, the company has achieved a leading position in the research and development of core technologies, including cascade low-temperature refrigeration system design, preparation of mixed refrigerants for multi-stage refrigeration, high-efficiency heat exchange technology, and constant temperature control technology.
Eco-friendly and energy-efficient -150°C ultra-low temperature freezers have become a critical industry bottleneck due to technical challenges such as refrigeration system configuration and refrigerant formulation. Haier Biomedical has boldly pursued innovation, successfully developing "Shenlan," a hydrocarbon-based, energy-efficient, highly stable, and efficient -150°C ultra-low temperature freezer. The product has obtained CE certification and secured an initial order of 60 units upon launch, garnering significant acclaim in the European market.
In terms of safe operation, a self-regulating pressure control system is employed to maintain a stable internal pressure environment within the refrigeration system; meanwhile, refrigerator alarms are transmitted in real-time via a mobile IoT app, ensuring timely safety warnings for stored samples. Regarding operational stability, the integration of next-generation hydrocarbon refrigerants with a dual-compressor, four-stage cascade refrigeration system enables reliable performance across a wide ambient temperature range of 10–32°C, while minimizing internal temperature fluctuations. In terms of energy efficiency, it achieves a 30% reduction in power consumption, setting an industry benchmark. For environmental sustainability, the use of hydrocarbon refrigerants represents a further upgrade in the eco-friendliness of ultra-low temperature products. Enhancing user experience, the unit operates at a low noise level of 55 dB, facilitating convenient placement and use in laboratory settings.
Company Abbreviation:Hisense Medical
Award-Winning Case Name:Hisense Medical Achieves Breakthrough in Overseas Expansion of High-End Medical Imaging Equipment
Award-Winning Product Image:
Selection Recommendation:
Hisense Medical, a subsidiary of Hisense Group, upholds the corporate mission of “Serving the medical cause and benefiting human health.” It boasts core products including independently developed color Doppler ultrasound systems, globally leading medical-grade displays, and industry-leading digital operating suites. The company has innovatively launched solutions for building digital minimally invasive interventional departments, spearheaded the development of the industry’s first group standard for remote ultrasound, and facilitated leapfrog development in China’s ultrasound medicine sector.
After nearly a decade of technological accumulation, Hisense has independently developed the HD60 series, a new generation of intelligent color Doppler ultrasound equipment with fully independent intellectual property rights. Multiple proprietary core technologies have filled gaps in China’s color Doppler ultrasound industry, broken the technological monopoly held by international brands, and achieved a major breakthrough in Shandong Province’s high-end medical imaging equipment sector. The product has been included in Shandong Province’s “First Set” equipment procurement list and has received numerous accolades, including being listed on the 2020 “Sci-Tech Innovation China” Leading Technologies List, recognized as an Excellent Domestically Produced Medical Device, and named a Qingdao Innovative Product.
In addition to obtaining certification from China’s National Medical Products Administration (NMPA), Hisense Ultrasound has successively secured overseas certifications, including CE MDR, US FDA, and South Africa’s SAHPRA. In 2021, Hisense Ultrasound officially entered the international market. Leveraging innovative technological design, it has successfully expanded into 11 countries, including South Africa, the United Arab Emirates, Indonesia, Thailand, and Germany. The company has completed external clinical application evaluations in general practice, obstetrics and gynecology, and cardiology. Overseas experts have highly praised its superior image quality and user-friendly operational workflow.
Company Abbreviation:Hybribio
Award-Winning Case Name:SOX1 and PAX1 Gene Methylation Detection Kit
Award-Winning Product Images:
Selected Recommendation:
Hybribio, established in 2003, is a developer and supplier of nucleic acid molecular diagnostic products in China. As of 2022, Hybribio’s HPV testing products have benefited 40 million women. The SOX1 and PAX1 Gene Methylation Detection Kit is a new product developed by Guangzhou Hybribio Medical Technology Co., Ltd., a subsidiary of Hybribio. It exclusively employs combined dual-gene methylation detection of SOX1 and PAX1. Compared with existing conventional TCT and HPV testing methods, it maintains high sensitivity while improving specificity. This kit can help identify high-risk populations for cervical cancer to some extent, triage patients who are HPV-positive or cytology-positive, and provide reference evidence for the diagnosis and treatment of cervical intraepithelial neoplasia (CIN) and cervical cancer. Meanwhile, it helps prevent overtreatment and reduce the medical burden. Currently, the SOX1 and PAX1 Gene Methylation Detection Kit has obtained EU CE certification and is available for sale in EU countries and other nations that recognize EU CE certification.
Company Abbreviation:United Imaging Healthcare
Award-Winning Case Name:Total-body PET-CT uEXPLORER Explorer
Award-Winning Product Image:
Selection Recommendation:
Shanghai United Imaging Healthcare Co., Ltd. (“United Imaging Healthcare”) is dedicated to providing global customers with a comprehensive portfolio of independently developed, high-performance medical imaging diagnostic and therapeutic equipment, life science instruments, and innovative solutions that encompass healthcare digitalization and intelligence, spanning the entire chain from “basic research–clinical research–medical translation.”
Guided by the vision of “becoming a world-class leader in medical innovation” and driven by the mission to “make a difference for universal health,” United Imaging Healthcare deeply collaborates with global universities, hospitals, research institutions, and industry partners. By continuously pushing the boundaries of technological innovation, the company accelerates the advancement of precision diagnosis and treatment as well as forward-looking scientific research, while steadily enhancing the global accessibility of high-end medical equipment and services.
To date, United Imaging Healthcare has assembled a world-class talent team and launched more than 80 products with fully independent intellectual property rights. These include several world-first and China-first innovations such as the Total-body PET-CT (2-meter PET-CT), the “spatiotemporal integrated” ultra-high-definition TOF PET/MR, the 75cm extra-large bore 3.0T MRI, the 640-slice CT, and the integrated CT-linac. The overall performance indicators have reached international first-class standards, with certain products and technologies achieving global leadership. Notably, its leading project, “Independent Development and Industrialization of High-field Magnetic Resonance Medical Imaging Equipment,” was awarded the First Prize of the 2020 State Scientific and Technological Progress Award, marking the industry’s first receipt of this highest honor in the field of science and technology. Today, these innovative products have been installed in over 9,400 clinical and research institutions across more than 50 countries and regions worldwide, including the United States, Japan, and Europe, among which are nearly 900 Grade A tertiary hospitals in China.
Founded in 2011, United Imaging Healthcare is headquartered in Shanghai, with regional headquarters and R&D centers established in the United States, Malaysia, the United Arab Emirates, Poland, and other locations.
The uEXPLORER total-body PET-CT scanner enables humanity, for the first time in history, to visually observe the complete processes of drug distribution, diffusion, and metabolism throughout the entire body. Hailed as the “Hubble Telescope” for human body imaging, it opens up limitless possibilities for precision cancer diagnosis and treatment, brain science research, and new drug development. The Institute of Physics’ *Physics World* named it one of the “Top 10 Scientific Breakthroughs of 2018,” and it has been featured extensively in *Nature* and *Science*.
Company Abbreviation:Venus Medtech
Award-Winning Case Name:VenusMedTech Transcatheter Pulmonary Valve VenusP-Valve™
Award-Winning Product Images:
Selection Recommendation:
Hangzhou Qiming Medical Device Co., Ltd. is a leading enterprise in China’s field of minimally invasive interventional therapy for heart valves, dedicated to the development and commercialization of innovative medical devices for structural heart disease.
VenusMedtech’s independently developed innovative device—the VenusP-Valve™ transcatheter pulmonary valve replacement (TPVR) system—received EU CE MDR certification in April this year, pioneering the entry of domestically produced artificial heart valves into the European market and marking a new height in the internationalization of Chinese innovative medical devices. As the first self-expanding TPVR product approved for marketing in Europe, VenusP-Valve™ demonstrates significant clinical value. Its unique double-flared design ensures stable anchoring and simplified deployment, eliminating the need for pre-implantation of a fixed stent. With a wide range of sizes and broad applicability, it meets the clinical needs of over 85% of patients. In May, VenusP-Valve™ received approval from the U.S. Food and Drug Administration (FDA) for two humanitarian use cases in the United States; these two humanitarian uses have since been successfully completed at the Advanced Heart Valve Center of the University of Virginia. This authorization for patient treatment, granted prior to the initiation of formal clinical studies in the U.S., fully highlights the product’s unique clinical advantages. In June, the first commercial case of VenusP-Valve™ in Europe was successfully performed in the United Kingdom, signaling a new milestone in VenusMedtech’s international expansion. In July, the product received marketing approval from China’s National Medical Products Administration (NMPA).
Venus Medtech has not only independently developed the innovative VenusP-Valve™, but has also ventured into “uncharted territory,” actively exploring pathways for overseas clinical trials and regulatory registration in Europe and the United States, achieving significant breakthroughs. This not only demonstrates the growing maturity of China’s independent innovation capabilities, but more importantly, provides a concrete model for the global expansion of Chinese medical device companies, holding substantial practical significance for boosting confidence in domestic industries and realizing the vision of “Intelligent Manufacturing in China.”
Company Abbreviation:Rainmed Medical
Award-Winning Case Name:Coronary Flow Fractional Reserve Measurement System (caFFR)
Award-Winning Product Images:
Recommended Citation:
Founded in 2014, Rainmed Medical Group is committed to becoming a global leader in vascular interventional surgical robotics. The company currently focuses on the design, research and development, and commercialization of two core products within the functional diagnostic module of its vascular interventional surgical robots: the Coronary Angiography-based Fractional Flow Reserve (caFFR) System and the Coronary Angiography-based Index of Microcirculatory Resistance (caIMR) System. Rainmed Medical actively collaborates with top-tier medical centers and experts both domestically and internationally, has established a comprehensive patent portfolio, and has signed strategic cooperation agreements with China’s leading medical device distribution service platforms. Additionally, the company has implemented rigorous quality control systems and robust supply chain processes. Looking ahead, Rainmed Medical will leverage its technical expertise in medical imaging algorithms, computational fluid dynamics analysis, high-performance mechanical design, and the development of advanced interventional consumables to launch vascular interventional surgical robots. By progressively developing unmanned operating rooms and enhancing the clinical value of its products, Rainmed Medical aims to pioneer a new era of precision medicine in the field of vascular intervention.
The caFFR system is an independently developed platform by Runmai De Medical, backed by comprehensive intellectual property rights. It evaluates various physiological parameters in patients with stable angina, unstable angina, and acute myocardial infarction, based on measured aortic pressure across different phases of the cardiac cycle. The caFFR system is the first to obtain both European CE certification and NMPA approval.
Company Abbreviation:Sinowei Medical Technology
Award-Winning Case Name:SinoMicro Medical Technology - Dophi® Irreversible Electroporation Therapy System
Award-Winning Product Image:
Selection Rationale:
SinoMicro MedTech specializes in the fields of minimally invasive surgery and interventional oncology. The company has established three major platforms: surgical vision, surgical energy, and interventional oncology therapy. It provides comprehensive solutions for minimally invasive surgical treatment globally, committed to delivering simple-to-use, high-quality, high-performance, and affordable cutting-edge surgical instruments to the world.
Dophi® High-Voltage Pulsed Electric Field Ablation System, an ablation product independently developed by SinoMicro Medical Technology, is the second irreversible electroporation (IRE) tumor ablation device worldwide to obtain EU CE certification and achieve real-world clinical application. It has been used in hundreds of IRE procedures in Europe, breaking the monopoly of international giants in the treatment of refractory tumors such as pancreatic cancer.
SinoMicro is accelerating the global promotion of the Dophi® Irreversible Electroporation System, making it accessible to more patients and establishing it as a new hallmark of China’s contributions to oncology treatment.
Company Abbreviation:MicroPort® Robot
Award-Winning Case Name:MicroPort® Honghu® Orthopedic Surgical Robot
Award-Winning Product Images:
Selection Recommendation:
Shanghai MicroPort MedBot (Group) Co., Ltd. (02252.HK, abbreviated as “MicroPort® MedBot”) was established in 2015. As a global leader in the medical robotics industry, its products span five “golden tracks”: laparoscopic, orthopedic, vascular intervention, natural orifice, and percutaneous puncture surgical robots. The company is committed to its mission of providing comprehensive intelligent robotic surgical solutions that extend and reshape lives, striving to “make no surgery difficult.” It was successfully listed on the Main Board of the Hong Kong Stock Exchange on November 2, 2021.
Honghu® boasts technical advantages such as precise operation, efficient collaboration, safety protection, and strong compatibility. Preoperatively, its planning system assists physicians in developing personalized prosthetic implantation plans based on the patient’s preoperative CT scan data and prosthetic model data. Intraoperatively, guided by precise positioning from the surgical plan and utilizing registration technology combined with a proprietary, highly dexterous, lightweight robotic arm, it enables rapid osteotomy, thereby enhancing surgical precision and efficiency. Honghu® (registered in the United States as SkyWalker™) received FDA 510(k) clearance in July 2022, becoming the first and only Chinese surgical robot to achieve FDA clearance to date, marking the entry of China’s surgical robotics industry into the ranks of international innovators.
Following Honghu’s receipt of U.S. FDA clearance, the company has commenced commercial promotion in the U.S. market and has established its first training center in the country to provide physician training. Meanwhile, the company’s overseas R&D center in the United States continues to expand, integrating innovative concepts and resources from the global surgical robotics sector to accelerate its globalization efforts.
Company Abbreviation:Vobi Medical
Award-Winning Case Name:Advancing Chinese Intelligent Manufacturing to World-Class Standards in Neurointervention – Avenir™ Mechanically Detachable Coils
Award-Winning Product Images:
Selected Recommendation:
Worbi Medical Holdings Co., Ltd. (hereinafter referred to as “Worbi Medical”) was established in December 2015, focusing on the development of innovative, breakthrough, and clinically validated technologies and solutions for the treatment of neurovascular diseases. In April 2022, Worbi Medical successfully acquired phenox GmbH (hereinafter referred to as “phenox”), a leading global company in the neurointerventional industry based in Germany. Following the acquisition, Worbi Medical possesses a comprehensive and globally competitive portfolio of neurointerventional products. The company currently operates five R&D centers and three production bases worldwide, with over 628 employees, and has secured or is pending more than 350 patents globally. Worbi Medical’s products are sold in 52 countries and regions around the world.
Among these, the Avenir mechanically detachable coils have received certification in the United States, the European Union, China, and Japan. The Esperance aspiration catheter (6F) and distal access catheter have obtained marketing authorization in China, while the Esperance aspiration catheter (6F/5F) has received U.S. marketing clearance. The pRESET thrombectomy stent, as well as the p64 and p48 flow diverters, have all secured marketing authorization in Europe.
Company Abbreviation:Snibe
Award-Winning Case Name:China’s First Company with EU CE List A Certification for Eight Chemiluminescence Infectious Disease Reagents Serves the Global Market
Award-Winning Product Images:
Selection Recommendation:
Snibe Co., Ltd. (Stock Code: 300832), established in 1995, is a national high-tech enterprise specializing in the research and development, manufacturing, sales, and services of in vitro diagnostic (IVD) products. The company has long been dedicated to research in the field of chemiluminescence immunoassay (CLIA). After more than a decade of focused efforts, it successfully registered and launched China’s first fully automated chemiluminescence analyzer in overseas markets in 2009. In 2017, Snibe obtained U.S. FDA 510(k) clearance, becoming the first Chinese CLIA manufacturer to gain access to the U.S. market. In 2018, the company successfully developed the MAGLUMI X8, a fully automated chemiluminescence immunoassay system. In 2019, Snibe’s hepatitis C chemiluminescence products successfully passed the EU CE List A certification, making it the first Chinese CLIA manufacturer to have hepatitis C reagents certified by the EU CE. In 2020, Snibe received China’s first IVDR CE certificate in the field of chemiluminescence. With over a decade of presence in overseas markets, the company has established cooperative relationships with end-users in 147 countries and regions, including Italy, Spain, France, and Colombia. Its instruments have been installed in multinational chain laboratories such as Synlab in Europe and the United States, breaking the previous absence of Chinese enterprises in this sector.
Snibe’s reagents for hepatitis B, hepatitis C, and HIV testing were evaluated by a leading European third-party clinical testing organization in accordance with the EU Common Technical Specifications. Rigorous study design, implementation, and analysis demonstrated that all performance indicators of the reagents meet the standards required for European certification.
Snibe Diagnostics is the first and currently the only in vitro diagnostics manufacturer in China to have obtained CE List A certification for all three major infectious diseases: HBV, HCV, and HIV.
Company Abbreviation:Xinguangwei Medical
Award-Winning Case Name:Innovative Single-Use Endoscope Products and Endoscopic Image Processing Devices
Award-Winning Product Images:
Selected Recommendation:
Xinguangwei Medical is a minimally invasive diagnosis and treatment enterprise focused on the research, development, and commercialization of medical endoscopes and related innovative products. Adhering to the strategic vision of “Based in China, with a Global Outlook,” the company has established R&D centers in both China and Japan. Leveraging its robust independent R&D capabilities, Xinguangwei Medical has built a proprietary technology platform grounded in five core technologies, creating a comprehensive portfolio of medical endoscopy products to meet diverse clinical needs.
Xinguangwei Medical’s single-use endoscope products (including single-use electronic bronchoscopes, single-use electronic ureterorenoscopes, single-use electronic cystorenoscopes, and single-use electronic hysteroscopes) and endoscopic image processing devices can effectively reduce the risk of clinical cross-infection compared to traditional endoscopes. This is particularly valuable in addressing critical clinical challenges against the backdrop of the global COVID-19 pandemic.
Xinguangwei Medical’s single-use endoscope delivers superior image quality and depth of field, along with a greater angulation range. While enhancing patient experience, it enables physicians to more easily access the target anatomical sites. Its working channel is compatible with a wider variety of diagnostic and therapeutic instruments, effectively improving clinical efficiency.
Among them, the single-use electronic ureterorenoscope and the endoscopic image processing system have been included in the Catalog of Excellent Domestically Produced Medical Equipment (Batch 8).
The company’s single-use endoscope products and endoscopic image processing devices have obtained regulatory approvals from the FDA, CE, PMDA, and TFDA in key overseas markets, along with international authorization of related intellectual property rights. After trial use by overseas medical institutions and distributors, the products have received high acclaim and are now ready for commercialization abroad, establishing the company as a leading Chinese brand in the global export of medical devices.
Scan the QR code to view details of award-winning cases.