醫療器材在中國的合規策略與智權布局—以中醫脈診儀為例

Abstract

全球中醫藥市場隨著對傳統中醫診療的需求增加及現代化技術的結合，持續快速成長，中醫脈診儀作為結合現代感測技術與人工智慧的中醫診療設備，能客觀量化傳統脈診技術，已成為當前市場發展的重要趨勢。儘管台灣與中國在中醫醫療器材發展上具備相近的文化背景，但在醫療器材法規及智慧財產權佈局方面仍存在顯著差異，相關業者亦須面對嚴格的監管要求與激烈的市場競爭。而在市場進入過程，法規合規與智權佈局並非獨立流程，兩者相互影響、密不可分，因此採取「同步規劃」的整合性策略有其關鍵性。 本研究旨在探討臺灣中醫脈診儀業者進入中國市場所需的醫療器材法規合規策略與智慧財產權佈局。研究方法採用文獻分析與次級資料研究法，剖析中國脈診儀的市場趨勢與技術特徵；其次，深入探討中醫脈診儀作為第二類醫療器材，在中國國家藥品監督管理局（NMPA）的註冊審批流程，包括產品技術要求制定、臨床評價方式、品質管理系統認證及註冊審批流程等；在智慧財產權方面，透過解析中國智慧財產權相關申請與註冊流程，提出針對中醫脈診儀採取之專利、著作權與商業秘密相結合的「組合式」保護策略，包括硬體與感測技術專利申請、軟體著作權登記、商業秘密管理及品牌商標保護等多元策略。期望透過提出相應的法規遵循與智權管理與互動建議，並協助制定具可行性的市場拓展藍圖，提升臺灣中醫脈診儀業者在中國市場的競爭力。

The global Traditional Chinese Medicine (TCM) market continues to experience rapid growth, driven by increasing demand for traditional TCM therapies and the integration of modern technology. TCM pulse diagnosis instruments, which combine advanced sensing technology with artificial intelligence, offer an objective quantification of traditional pulse diagnostic techniques and have emerged as a significant trend in current market developments. Despite Taiwan and China sharing similar cultural backgrounds in the development of TCM medical devices, notable differences remain in their regulatory frameworks and intellectual property (IP) strategies. Manufacturers also face stringent regulatory requirements and intense market competition. Hence, adopting an integrated "synchronized planning" strategy for regulatory compliance and IP protection is crucial, as these aspects are interrelated and mutually influential. This study aims to explore the regulatory compliance strategies and IP arrangements required for Taiwanese manufacturers to enter the Chinese market with TCM pulse diagnosis instruments. Using literature reviews and secondary data analysis, this research analyzes the market trends and technical features of pulse diagnosis instruments in China. It further examines the registration and approval process by China's National Medical Products Administration (NMPA) for Class II medical devices, including the formulation of product technical specifications, clinical evaluation approaches, quality management system certification, and the overall registration process. Regarding IP, the study investigates the application and registration procedures for patents, copyrights, and trade secrets in China, proposing a comprehensive IP protection strategy that includes patent applications for hardware and sensing technologies, software copyright registration, trade secret management, and trademark protection. This study provides recommendations to enhance the interplay between regulatory compliance and IP management, aiding in the development of practical market expansion blueprints to improve the competitiveness of Taiwanese TCM pulse diagnosis instrument manufacturers in the Chinese market.