醫療器材電性安全法規之整編

The Study of Regulatory for Safety of Medical Electrical Equipment

吳俊璋(Chun-Chang Wu)

中原大學/工學院/生物醫學工程研究所/碩士(2012年)

https://doi.org/10.6840/cycu201201057

摘要

近年來由於全球趨勢性的人口老化及生育率普遍的下降，隨著醫療科技的進步與發展，各國對醫療器材之需求則有不斷增加的情形，然而醫療器材產業不同於其他一般的消費性產品產業，因必定會牽渉及到人身的生命與安全，各國政府的衛生主管機關對醫療器材均訂立有各種法規標準與規範，其中如產品之預期用途、製造、規格、操作手冊、標示、廣告與銷售等則是主要受到法規管制的項目之一。例如: 某家電子公司欲投入醫療器材產業並希望將研發醫療用電子血壓計銷售至歐美國家，根據台灣藥事法之規定，公司在成立初期時就先需要申請藥商販售許可執照及製造業者工廠登記證，再依據衛署藥字第0930328238號之規定，申請認證時需符合醫療器材醫療優良製造規範ISO 13485品質管理系統GMP，最後透過器材判定資料庫輸入血壓計的關鍵字來確認產品的分類分級，而醫用血壓計所需符合的測試及驗證標準則需參考行政院衛生署公司電子血壓計臨床前測試基準草案部分，實施測試及驗證使產品達到之符合產品之安全性及有效性之目標。
由於我國在醫療器材產業結構上，目前仍是以接受歐盟、美國與日本等品牌商醫電設備代工為主要業務內容，所以在醫療器材產品在申請上市時，常有因銷售區域或國家所屬的醫療器材法規及標準不同，造成廠商在「臨床試驗」與「法規」這兩個部分困擾及混淆，因此本論文將以目前市面上現有醫電設備之醫療器材產品為例，依據醫療器材產業市場、各國醫療器材法規及醫療器材測試標準來探討，醫療器材產業未來趨勢與醫療器材產品測試差異性。其中論文在第一部分將針對醫療器材產業的市場趨進行分析，並側重於台灣醫療器材產業與世界醫療器材產業項目的差異比對，並探討台灣目前遇到主要的困境，以及可能因應的策略。本論文在第二部分將探討醫療器材產品在歐美先進國家上市時，常遇到產品申請上市時在醫療器材法規上的困擾，例如在申請美國外上市時需要符合美國食品藥物管理局相關認證及規範，而在歐洲申請時需符合歐盟認證卻又不同於美國的規範。爾後並以各國醫療器材在法源上的依據，分析並整理所管轄主管機關對各醫療器材的定義及修改的方向，並以中國為例，探討由於而醫療器材品質管理系統沒有委有第三方驗證單位做驗證稽核所衍生的問題，以及各國的查驗登記依據實際需求而產生的差異及變化。 最後，本論文在第三部分將分析各國在醫療器材產品申請上市時所需符合的醫療器材標準上的差異，例如血壓計在申請美國外上市時除了需要符合IEC 60601-1電性安全、IEC 60601-1-2電磁相容性外，還需要符合AAMI SP10美國醫用血壓計的相關認證及規範，但在歐洲申請上市時則除需符合IEC 60601-1、IEC 60601-1-2外，卻改要求產品需符合EN 1060規範，這類同類產品卻因地域性的區隔所造成在認證及規範上的差異。
總而言之，本研究的目的是要對歐美各國醫療器材市場及各國醫療器材法規趨勢及醫電設備的電性基本安全規範發展整理及分析，其中首先針對國際重要市場如美國、歐洲與台灣相關的制度及醫療器材相關規範，進行法規資料的收集與研究，希望藉由分析整理了解各國醫療器材申請的相關流程與準備文件，進一歩了解在各國認證申請程序上常見的問題及淺在的危機，以供台灣廠商未來申請的參考及借鑒。
本研究獲得以下結論：
1.台灣醫療器材產業是以居家用醫療器材產品為主，而世界醫療器材產業是以生產診斷醫療設備產品，產業結構差異甚大。
2.世界各國醫療器材查驗登記規範皆由當地主管機關管轄，而ISO 13485品質系統的工廠檢查與法規審查部分，世界各國都委由第三方驗證機構查核，唯有中國是由官方機構自行查核
3.各國醫療器材法規在電性安全、電磁相容性、軟體驗證、風險管理相關的標準只有新舊版本差異，而標準部分均為一致。

關鍵字

電性安全試驗 ； 電磁相容性試驗 ； 生物相容性試驗 ； 功能性試驗

並列摘要

Due to the global trend of an aging population and fertility widespread decline in recent years, with the progress and development of medical technology, national demand for medical equipment is increasing, however, the medical devices industry is different from other consumer productsindustry, due to the life and security will pull Die to the person, the health authorities of the Governments of medical equipment are entered into a variety of regulatory standards and norms, such as the intended use of the product, manufacturing, specifications, operating manuals, labeling, advertisingand sales is one of the items subject to regulatory control. For example: an electronics companies want to put into the medical equipment industry and hope that the development of medical electronic sphygmomanometer sales to Europe and the United States, according to the provisions of the Pharmaceutical Affairs Law in the early days of the first required to apply for drug dealers to sell the license and manufacturing factory registration certificate, according to the provisions of DOH drug No. 0930328238, the application for certification must meet good manufacturing practice of medical equipment medical ISO 13485 quality management system GMP, and finally through the equipment to determine the keywords of the database input sphygmomanometer to confirm the product's classification and grading of medical sphygmomanometer required to comply with the testing and verification standards need to refer to the Department of Health, the company electronic sphygmomanometer clinical test before baseline draft part, the implementation of testing and validation in line so that products meet the product safe and effective the nature of the target.

In the medical devices industry structure, China is currently still is to accept the European Union, the United States and Japan and other brands Medical electrical equipment OEM for the main business application for listing in the medical device, often due to sales regions or countries belong medical equipment regulations and standards, resulting in the vendors in the "clinical trial" and "regulations" the two parts anxiety and confusion, so the papers will be available in the market of medical electrical equipment medical equipment products, for example, according to the Medical Device Industry market, the regulations of the national medical equipment and medical equipment testing standards to explore future trends and medical equipment product testing differences in the medical devices industry. Which the papers in the first part of the medical equipment industry market trends were analyzed, and focused on the Taiwan medical equipment industry and the world's medical equipment industry projects difference right, and to explore Taiwan is currently experiencing major difficulties, and may be a coping strategy. This thesis in the second part will explore the medical equipment listed on the advanced countries in Europe and America, often encountered in the troubled product applications listed in the regulations on medical equipment, such as when to apply for the U.S. and overseas stock markets need to comply with the U.S. Food and Drug Administration certification and norms, the need to comply with EU certification but is different from the norms of the United States in the European application. Later, the source of law on the basis of national medical equipment, analysis and organize under the jurisdiction of the competent authority on the definition of medical equipment and modify the direction of, and China, for example, on a third party to the Medical Device Quality Management System Committee Verify that the unit to do the problems arising from the certification audit, and the countries of the inspection and registration of the differences and changes based on actual demand. Finally, the third part will analyze the differences in the medical equipment meet the standards required to apply for listing of the countries in the medical equipment products, such as blood pressure monitors in the application for the U.S. and overseas stock markets need to comply with IEC 60601-1 electrical safety IEC 60601-1-2 Electromagnetic compatibility outside, also need to comply with the certification and specification of the AAMI SP10 medical sphygmomanometer, in the European application is listed in addition to the need to comply with IEC 60601-1, IEC 60601-1-2 outside, but to change the products need to comply with EN 1060 specifications, and such similar products because of the regional segmentation caused by differences in the certification and specification.

All in all, the purpose of this study is the collation and analysis of To Europe and the United States medical equipment market and the national medical equipment regulatory trends and medical electrical equipment, electrical safety specification development, which first of all important international markets such as USA, Europe and Taiwan system and medical equipment specifications, and regulations data collection and research, to organize national medical equipment application process and the preparation of documents by analyzing further steps to understand the common problems in the national certification application procedures and the light in the crisis to for Taiwan manufacturers to apply for future reference and learn from.

並列關鍵字

Electrical Safety test ； Electromagnetic compatibility test ； Biocompatibility test ； Performance test

參考文獻

[24]Active Implantable Medical Device Directive，90/385/EEC ，下稱AIMDD。

[26] 全球醫療器材法規調和會GHTF中文版指引資料庫，http://ghtf.cms.itri.org.tw/index.php?option=com_content&view=article&id=451%3Asg1-n41r92005&Itemid=162

[30]The Council Directive on Medical Devices Directive ，93/42/EEC ，下稱MDD。

[31]In Vitro Diagnostic Medical Device Directive，98/79/EC，下稱IVDD。

[36]IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance (2005)