The Medical Device Forum of 2026 Zhangjiang Pharma Valley Innovation Conference was held at the Shanghai Zhangjiang Science Hall from August 28 to 29. LINKS CRO, a professional CRO specializing in clinical research for implantable and interventional medical devices, participated in the event throughout. On August 29, LINKS CRO hosted the sub-forum “Connecting China and Europe: EU Clinical Access Forum for High-Performance Medical Devices”, with a dedicated networking booth A6 at Hall 1H.
Against intensified competition in China’s medical device sector, overseas expansion has evolved from an optional strategy into a necessity. Nevertheless, market entry into the EU remains fraught with challenges, including the complexity of the MDR regulation, divergent logics for clinical evidence, GDPR data compliance, and extrapolation of clinical data across ethnic populations.
Centered on EU clinical access and globalisation pathways for high-performance Chinese implantable and interventional devices, the sub-forum covered a wide range of topics: clinical evidence requirements under EU MDR, practical implementation of PMCF, mutual recognition of clinical data between China and Europe, ethnic extrapolation, GDPR data compliance, differentiated overseas expansion under the Belt and Road Initiative, and commercialisation. More than ten distinguished speakers were invited, including representatives from EU notified bodies, overseas CROs, clinical institutions, law firms and industry players, forming a complete ecosystem covering regulatory review, CRO services, clinical operations, compliance and commercialisation.
The morning session opened with addresses by Dr. Chen Zhenlang, Founder and General Manager of LINKS CRO, and Gu Leimin, Venture Partner at YuanSheng Ventures. Dr. Chen pointed out that many domestically approved NMPA devices frequently receive deficiency letters after MDR submission in the EU. The root cause lies in structural differences between China and EU regulatory systems in judging valid clinical evidence. He also noted that 2026–2027 constitutes a critical window for high-risk Chinese medical devices to establish presence in the EU market. Gu Leimin divided overseas expansion into two phases: “go out” (obtaining overseas registration certificates) and “go in” (deeply cultivating local markets). Dr. Gert Bos, former President of RAPS, outlined the evolution of global regulatory landscape. Professor Mark Da Costa, senior former reviewer at an EU notified body, interpreted the clinical evidence requirements under EU MDR.
Subsequently, Dr. Chen delivered a presentation titled From Gap to Bridge, stressing that enterprises must proactively plan PMCF post-market clinical follow-up, and proposed bridging strategies for tough issues such as ethnic extrapolation. Dr. Wu Tiangen, Chairman of TDT Medical, argued that Chinese medical devices should break away from the “low-price” stereotype. Gu Xinzhong, Head of Regulatory & Registration at LINKS CRO, elaborated on the acceptable scope of Chinese clinical data for MDR applications and the CE certification pathway. The morning panel discussion explored the tension between the “generality” and “regionality” of clinical evidence.
The afternoon session kicked off with an address by Tian Ruixue, Director of the Shanghai Lingang Medical Equipment Technology Industry Research Center, who stated that the life health sector serves as a vital bond for China-Europe cooperation. Helene Quie, General Manager of QMED Europe, shared hands-on experience in EU multi-centre clinical trials and PMCF data collection. Professor Lu Fanglin, Director of Cardiac and Great Vascular Surgery at Shanghai First People’s Hospital, Shanghai Jiao Tong University School of Medicine, took the LuX-Valve transcatheter tricuspid valve replacement system as a case study, reviewing the full journey of an original Chinese high-risk device from first-in-human trial to EU MDR certification. Cai Xin, Vice President of Medidata, focused on three regulatory frameworks: MDR, GDPR and AI Act, emphasising digital compliance as the cornerstone of cross-border clinical research. Liu Junzuo, Senior Attorney at Jincheng Tongda & Neal, clarified the roles of CROs, sponsors and research sites under GDPR. He highlighted that sponsors cannot transfer their data compliance obligations by delegating work to CROs, and warned that remote access to data stored overseas from within China triggers cross-border compliance duties, meaning data compliance must be planned at the early project stage. Tian Ruixue proposed a dual-track strategy targeting “EU + emerging markets”, and recommended that domestic enterprises collaborate for global expansion.
Panel Session 2 in the afternoon was moderated by Robert Pang, Medical Director of LINKS CRO. All panelists agreed that overseas expansion has become an industry imperative. China boasts abundant clinical resources and robust manufacturing capabilities, yet gaps persist in international compliance and local ecosystem building. High-quality clinical evidence is not merely a tool to secure regulatory approvals, but also a commercial asset. Enterprises should avoid pursuing overseas registration as an end in itself. The forum concluded with a closing speech by Dr. Chen Zhenlang, themed “LINKS — The Bridge Connecting China and Europe”.
During the conference, LINKS CRO maintained a dedicated networking zone at Booth A6. Over the two days, it welcomed representatives from more than a hundred medical device manufacturers, investment institutions and clinical specialists for consultations. Services covered clinical protocol design, registration query support, interpretation of domestic and international regulations, and project assessment.
The globalisation journey of China’s high-performance medical devices continues to accelerate. Upholding its mission of “Connecting China and Europe”, LINKS CRO will keep delivering end-to-end services for innovative Chinese medical device enterprises, spanning clinical strategy formulation, protocol design, SSU initiation, GCP-compliant execution, data management, continuous PMCF follow-up, and NMPA/CE/FDA registration applications. LINKS CRO supports more original high-performance Chinese medical devices to enter the global marketplace.
