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為更好地向全球醫療科技行業介紹中國創新醫療器械的發展情況，思宇MedTech正在策劃編寫《中國創新醫療器械產業化觀察白皮書2026》英文版。

英文版擬定名稱為：

China MedTech Innovation & Commercialization White Paper 2026 A 12-Year Review of NMPA-Approved Innovative Medical Devices

本白皮書將基于NMPA創新醫療器械注冊證相關信息，系統梳理中國創新醫療器械過去十余年的發展趨勢、獲批產品、創新主體、區域分布、國際化路徑及代表性企業案例。

與中文版相比，英文版將更加注重向海外讀者解釋中國醫療器械監管體系、NMPA創新醫療器械特別審查程序、注冊證含義、中國創新企業發展階段，以及部分中國企業在FDA、CE、海外臨床和全球商業化方面的進展。

# 為什么征集英文信息？

在英文版白皮書中，企業名稱、產品名稱、海外網站及LinkedIn賬號將直接影響海外讀者對企業的識別、檢索和進一步了解。

由于部分中國創新醫療器械企業尚未形成統一公開的英文名稱、英文產品名稱或海外傳播入口，為避免翻譯不一致、企業信息不完整，我們現面向相關企業征集標準英文信息。

歡迎已獲得NMPA創新醫療器械注冊證、已進入NMPA創新醫療器械特別審查程序，或正在推進海外注冊、海外臨床、FDA突破性器械項目、CE認證及全球商業化布局的企業提供相關資料。

# 請企業提供以下信息

請相關企業于2026年5月31日前提供以下信息：

1. 企業中文全稱、企業標準英文名稱、企業英文簡稱（如有）

2. 已獲批創新醫療器械的產品的NMPA注冊證號、中文名稱、英文名稱

3. 產品所屬領域或適應證方向，中英文

4. 企業英文官網或海外官網鏈接，如有

5. 企業LinkedIn賬號鏈接，如有

6. 產品是否已有FDA、CE、MDR、510(k)、De Novo、PMA、FDA Breakthrough Device Designation等海外注冊或創新通道進展，如有請簡要說明

7. 企業希望英文版中使用的100–150詞英文簡介，如有

如企業未提供標準英文信息，白皮書英文版將基于公開資料對企業名稱和產品名稱進行英文直譯或音譯處理；如未提供海外官網、LinkedIn賬號或海外注冊進展信息，則英文版中將不主動補充相關海外信息。

# 英文版擬定目錄China MedTech Innovation & Commercialization White Paper 2026 ——A 12-Year Review of NMPA-Approved Innovative Medical Devices
Chapter 1 Understanding China’s Innovative Medical Device Pathway1.1 What is NMPA? 1.2 What is the Special Review Procedure for Innovative Medical Devices? 1.3 What does an NMPA approval mean? 1.4 How China’s innovative device pathway differs from FDA breakthrough-related programsChapter 2 A 12-Year Overview of China’s Innovative Medical Device Approvals2.1 Approval trends from 2014 to 2026 2.2 Key stages in China’s MedTech innovation development 2.3 What the approval data reveals about China’s innovation landscape 2.4 From individual product approvals to a broader innovation ecosystemChapter 3 Product Landscape: What Types of Innovative Devices Have Been Approved3.1 Major product categories 3.2 Key clinical areas and application scenarios 3.3 Devices, implants, software, IVD and digital solutions 3.4 Representative innovation directions emerging from the approval dataChapter 4 Companies, Regions and Innovation Clusters4.1 Domestic and imported innovative device approvals 4.2 Emerging Chinese MedTech innovators 4.3 Multinational companies and innovative product approvals in China 4.4 Regional clusters: Beijing, Shanghai, Jiangsu, Guangdong, Zhejiang and beyondChapter 5 From China Approval to Global Expansion5.1 Chinese innovative medical device companies going global 5.2 FDA Breakthrough Device Designation and other global innovation pathways 5.3 FDA, CE, MDR and international clinical development 5.4 From product export to global clinical, regulatory and commercial strategiesChapter 6 Company Case Studies6.1 Cardiovascular and endovascular innovation 6.2 Surgical robotics and intelligent surgery 6.3 Medical imaging, AI software and digital health 6.4 Ophthalmology, orthopedics, neurology, oncology and other specialty areas 6.5 Service providers supporting innovative device commercializationChapter 7 Outlook: The Next Stage of China MedTech Innovation7.1 From single-product innovation to integrated solutions 7.2 From regulatory approval to clinical adoption and commercialization 7.3 From China market access to global market participation 7.4 From company-level breakthroughs to ecosystem-level competition 7.5 Innovation directions to watch after 2026 Appendix: Database of NMPA-Approved Innovative Medical Devices Appendix 1 List of NMPA-approved innovative medical devices Appendix 2 Approvals by year Appendix 3 Approvals by product category Appendix 4 Approvals by company location Appendix 5 Domestic and imported approvals Appendix 6 Selected companies with global expansion signals