文章來源: 思 宇Me dTec h
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為更好地向全球醫(yī)療科技行業(yè)介紹中國創(chuàng)新醫(yī)療器械的發(fā)展情況,思宇MedTech正在策劃編寫《中國創(chuàng)新醫(yī)療器械產(chǎn)業(yè)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(chuàng)新醫(yī)療器械注冊證相關(guān)信息,系統(tǒng)梳理中國創(chuàng)新醫(yī)療器械過去十余年的發(fā)展趨勢、獲批產(chǎn)品、創(chuàng)新主體、區(qū)域分布、國際化路徑及代表性企業(yè)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(yī)療器械監(jiān)管體系、NMPA創(chuàng)新醫(yī)療器械特別審查程序、注冊證含義、中國創(chuàng)新企業(yè)發(fā)展階段,以及部分中國企業(yè)在FDA、CE、海外臨床和全球商業(yè)化方面的進(jìn)展。
# 為什么征集英文信息?
在英文版白皮書中,企業(yè)名稱、產(chǎn)品名稱、海外網(wǎng)站及LinkedIn賬號將直接影響海外讀者對企業(yè)的識別、檢索和進(jìn)一步了解。
由于部分中國創(chuàng)新醫(yī)療器械企業(yè)尚未形成統(tǒng)一公開的英文名稱、英文產(chǎn)品名稱或海外傳播入口,為避免翻譯不一致、企業(yè)信息不完整,我們現(xiàn)面向相關(guān)企業(yè)征集標(biāo)準(zhǔn)英文信息。
歡迎已獲得NMPA創(chuàng)新醫(yī)療器械注冊證、已進(jìn)入NMPA創(chuàng)新醫(yī)療器械特別審查程序,或正在推進(jìn)海外注冊、海外臨床、FDA突破性器械項(xiàng)目、CE認(rèn)證及全球商業(yè)化布局的企業(yè)提供相關(guān)資料。
# 請企業(yè)提供以下信息
請相關(guān)企業(yè)于2026年5月31日前提供以下信息:
1. 企業(yè)中文全稱、企業(yè)標(biāo)準(zhǔn)英文名稱、企業(yè)英文簡稱(如有)
2. 已獲批創(chuàng)新醫(yī)療器械的產(chǎn)品的NMPA注冊證號、中文名稱、英文名稱
3. 產(chǎn)品所屬領(lǐng)域或適應(yīng)證方向,中英文
4. 企業(yè)英文官網(wǎng)或海外官網(wǎng)鏈接,如有
5. 企業(yè)LinkedIn賬號鏈接,如有
6. 產(chǎn)品是否已有FDA、CE、MDR、510(k)、De Novo、PMA、FDA Breakthrough Device Designation等海外注冊或創(chuàng)新通道進(jìn)展,如有請簡要說明
7. 企業(yè)希望英文版中使用的100–150詞英文簡介,如有
如企業(yè)未提供標(biāo)準(zhǔn)英文信息,白皮書英文版將基于公開資料對企業(yè)名稱和產(chǎn)品名稱進(jìn)行英文直譯或音譯處理;如未提供海外官網(wǎng)、LinkedIn賬號或海外注冊進(jìn)展信息,則英文版中將不主動補(bǔ)充相關(guān)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
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