台灣體外診斷醫療器材的審查流程及國際比較─從核酸檢測產業界的觀點出發

Abstract

「精準醫療」(Precision Medicine)與「預防醫學」(Preventive Medicine)是現今全球醫療器材產業的兩大發展願景，而無論是「精準醫療」或是「預防醫學」，體外診斷醫療器材的研發與應用都勢必將扮演著舉足輕重的地位，而各國訂定的醫材法規規範與審查流程是否能適時地因應與時俱進的大環境，將會是未來醫療器材產業成敗的關鍵之一。 隨著世界各國政府對於體外診斷儀器與試劑耗材的需求急遽上升，醫療器材產品相關的認證與審查流程也一再地被放大檢視，因此本文的研究目的可細分為以下幾點：(一)從核酸檢測產業界的觀點出發，探討台灣體外診斷醫療器材的審查及執行現況，並提出具體的討論方向；(二)比較台灣與美國、歐盟等國外現行的醫療器材審查規範，釐清醫材產品上市前的作業程序，以利我國醫療器材業者申請國內及國外的認證時能有依循的標準；(三)剖析現階段醫材法規在規範與實務執行面向上的落差，進而提出需要改善的建議，作為未來修訂法規時可參考的依據。 本研究先以「文獻分析法」為基礎，藉由蒐集整理國內外相關的文獻資料，針對我國體外診斷醫療器材的法規與審查流程進行細究，接著探討美國與歐盟現行對醫材法規的審查標準和發展趨勢，並以此作為研究設計上之參考；再運用「深度訪談法」來與從事核酸檢測相關醫療器材產業的台灣中小企業高階主管進行深度訪談，除期望能更了解台灣業者在申請認證時所面對的困難外，也希冀能從更多元的角度來審視我國體外診斷醫材法規訂定的依據與審查的標準。 本研究從核酸檢測產業界的立場與觀點出發，透過文獻分析與深度訪談12位體外診斷醫療器材業界中的高階主管得知，多數受訪者認為我國現行針對體外診斷醫療器材的審查規範，除可訂定體外診斷醫療器材認證的明文規範、制定標準的體外診斷醫療器材審查流程外，也可參考美國與歐盟落實分級管理的制度，並適時提供國內外法規釋義輔導、認證申請協助，以及專員諮詢，落實台灣政府強化國內生技醫療產業未來發展的決心，並藉此增進與國際接軌的核心能力。 關鍵字：精準醫療、預防醫學、醫療器材、體外診斷醫療器材、醫療器材法規、審查流程、深度訪談法、文獻分析法。

“Precision Medicine” and “Preventive Medicine” are the two major development visions of the global medical device industry. In the two visions, the development and application of In-Vitro Diagnostic Devices (IVD) will be bound to play a decisive role. Whether the regulation and examination of medical device in various countries can keep pace with the times will be one of the keys to the success or failure of the medical device industry in the future. With the rapid increase in the demand for IVD and reagent by governments around the world, the accreditation and review process related to medical device products has been closely watched. Therefore, the research purposes of this study can be divided into the following points: (1) From the perspective of Nucleic Acid Testing (NAT) industry, we will discuss the existing review process and its implementation of IVD in Taiwan, and propose specific discussion directions; (2) Compare the medical devices related regulations in Taiwan with the United States and the European Union, and clarify the operating procedures of the product introduction, so that our medical devices can follow the standards when applying for domestic and foreign accreditation; (3) Analyze the current gap between the standard and the practical implementation of medical devices regulations, and then propose suggestions for improvement as a basis for future revision of regulations. This research first used “document analysis” to collect and review the relevant domestic and foreign literatures, to conduct a detailed study on the regulations and review process of IVD in Taiwan, the United States and the European Union. The research makes an overall investigation of the above literature, and uses it as the reference for the research design. Then the research use in depth interview to interview 12 top managements of small and medium business engaged in the Nucleic Acid Testing (NAT) medical device industry in Taiwan, to better understand the difficulties faced by the business when applying for accreditation, and also to examine the basis and the standard for review of the medical devices regulations in Taiwan. Most interviewees believed that the current review process for IVD can set text specifications for accreditation, formulate standard for review process more clearly by referring to the United States and the European Union to implement classified management systems, and provide domestic and foreign legal interpretation counseling, accreditation application assistance, and consultation specialist. In the future, it is hoped that the government will implement its determination to strengthen the future development of the domestic biotechnology and medicine industry, and then enhance the core capabilities in line with international standards. Key words:Precision Medicine, Preventive Medicine, Medical Device, In-Vitro Diagnostic Devices, Medical Device Regulation, Review Process, Depth Interview, Document Analysis