《中国创新医疗器械产业化观察白皮书2026》英文版信息征集的通知

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为更好地向全球医疗科技行业介绍中国创新医疗器械的发展情况，思宇MedTech正在策划编写《中国创新医疗器械产业化观察白皮书2026》英文版。

英文版拟定名称为：

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

本白皮书将基于NMPA创新医疗器械注册证相关信息，系统梳理中国创新医疗器械过去十余年的发展趋势、获批产品、创新主体、区域分布、国际化路径及代表性企业案例。

与中文版相比，英文版将更加注重向海外读者解释中国医疗器械监管体系、NMPA创新医疗器械特别审查程序、注册证含义、中国创新企业发展阶段，以及部分中国企业在FDA、CE、海外临床和全球商业化方面的进展。

# 为什么征集英文信息？

在英文版白皮书中，企业名称、产品名称、海外网站及LinkedIn账号将直接影响海外读者对企业的识别、检索和进一步了解。

由于部分中国创新医疗器械企业尚未形成统一公开的英文名称、英文产品名称或海外传播入口，为避免翻译不一致、企业信息不完整，我们现面向相关企业征集标准英文信息。

欢迎已获得NMPA创新医疗器械注册证、已进入NMPA创新医疗器械特别审查程序，或正在推进海外注册、海外临床、FDA突破性器械项目、CE认证及全球商业化布局的企业提供相关资料。

# 请企业提供以下信息

请相关企业于2026年5月31日前提供以下信息：

1. 企业中文全称、企业标准英文名称、企业英文简称（如有）

2. 已获批创新医疗器械的产品的NMPA注册证号、中文名称、英文名称

3. 产品所属领域或适应证方向，中英文

4. 企业英文官网或海外官网链接，如有

5. 企业LinkedIn账号链接，如有

6. 产品是否已有FDA、CE、MDR、510(k)、De Novo、PMA、FDA Breakthrough Device Designation等海外注册或创新通道进展，如有请简要说明

7. 企业希望英文版中使用的100–150词英文简介，如有

如企业未提供标准英文信息，白皮书英文版将基于公开资料对企业名称和产品名称进行英文直译或音译处理；如未提供海外官网、LinkedIn账号或海外注册进展信息，则英文版中将不主动补充相关海外信息。

# 英文版拟定目录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