如何確保醫療器材品質：國際制度比較與我國制度現況分析

How to Ensure the Quality of Medical Device：An International Comparison of the Regulatory Systems and the Current Conditions in Taiwan

林綺莉(Chi-Li Lin)

指導教授 ： 鄭雅文

國立臺灣大學/公共衛生學院/健康政策與管理研究所/碩士(2011年)

https://doi.org/10.6342/NTU.2011.10593

摘要

背景：醫療器材品質攸關健康照護效益，為確保醫療器材品質，我國自1999年施行醫療器材優良製造規範，並將醫療器材品質系統驗證列為醫療器材上市審查之程序。近年我國積極推動醫療器材生技產業發展與兩岸經濟合作架構協議之「海峽兩岸醫藥衛生協議」簽署，醫療器材管理面臨簡化法規審查與加速上市時程之衝擊。

目的：本研究旨在審視我國醫療器材品質管理體制是否健全足以因應政策開放之風險危害，並符合國際管理制度走向。

方法：本研究採用（一）文獻分析法。（二）專家深度訪談法。藉由文獻蒐集、分析，進行醫療器材品質系統之國際制度比較，瞭解與國際接軌的法規調和方向；並透過14位專家深度訪談，探討國內制度當前問題，整合提出政策建議。

結果：本研究結果顯示我國醫療器材品質管理制度相較於國際管理制度，現況問題包括三個面向，為下列12項：（一）法規層面：（1）法令未及時符合國際變化；（2）醫療器材許可證、藥政系統、不良醫療器材通報，未與GMP/QSD品質系統建置連結；（3）對於經銷商或輸入業者無查核及規範；（4）無查核免GMP之一等級醫療器材廠；（5）製造廠定義與製程認定不清。（二）執行層面：（6）查核頻率低於國際/未分查核層次；（7）衛生署對於代施查核機構欠缺監督機制；（8）上市後管理機制薄弱；（9）衛生署欠缺醫療器材檢測能力；（10）國產廠GMP與輸入廠QSD審查欠缺公平性。（三）認知態度層面：（11）廠商對品質系統的落實程度；（12）政府無對違反GMP處置之強制力。

討論與建議：鑑於醫療器材全球化供應之情勢，國際間區域法規結盟、簽訂自由貿易協定風潮興盛，未來醫療器材管理勢必走向國際相互承認以及互惠政策開放，如何確保醫療器材的品質，健全醫療器材品質管理體制儼然為重要課題。故本研究對相關醫療器材品質的各關係人提出建議：（一）政府主管機關：健全醫療器材完全生命週期管理、加強國際相互認證、提升TFDA專業素養、落實執法強制力。（二）醫療器材製造廠商：體認企業責任、具備研發技術、順服法規要求。（三）醫療器材使用者：教育使用者、全民監督。期望能給予國家在致力於醫療器材國際競爭力同時，應以確保醫療器材品質之公共健康利益為首要考量的省思。

關鍵字

醫療器材 ； 品質系統 ； 醫療器材優良製造規範

並列摘要

Background：The quality of medical devices is closely related to the efficacy of healthcare. To ensure the quality of medical devices, the Good Manufacturing Practice (GMP) for medical devices has been implemented in Taiwan since 1999. Meanwhile, a regulation system to certify medical devices has also been incorporated into medical devices launch feasibility reviews. Recently, authorities in Taiwan are aggressively pursuing the development of biotechnology related to medical devices and the signing of the “Cross-Strait Medical Health Framework” under the cross-strait Economic Cooperative Framework Areement (ECFA). Consequently, Authorities in Taiwan are under the pressure of simplifying regulation reviews and accelerating the launch timeline of medical devices.

Objective：The purpose of this study was to evaluate whether the medical device regulatory system in Taiwan is sufficiently established to withstand the impact of a new and potientially more “open” policy on medical devices, and whether the system can still meet the quality standard of international regulatory systems after the new policy is implemented.

Methods：The methods of this study included literature review and in-depth interviews. Relevant literature was reviewed to compare the medical device regulatory system in Taiwan to similar sytems in other countries, with the goal of clarifying future directions for harmonizing the Taiwanes system with international systems. The in-depth interviews were conducted to identify issues in the current Taiwanese system in order to propose recommendation for relevant policies.

Results：Compared with regulatory systems internationally, this study identified the following 12 issues in Taiwanes system , arranged by three major dimensions: （I）Regulation：（1）policies are not amended efficiently when international regulations change；（2）certification of medical devices, medical administration system, and adverse medical device reaction report system are not linked to the GMP/QSD quality system；（3）there is no regulatory policy on medical device dealers and importers；（4）no inspection is required for non-GMP manufacturers；（5）it is unclear to define medical device manufacturers and the assembly process.（II）Execution：（6）the frequency of inspection is lower than that of international standards/There is no specification on the level of inspection.（7）Department of Health does not have a monitoring system for agencies that conduct inspection on behalf of the government.（8）the regulation of post-market is weak.（9）Department of Health does not have sufficient expert knowledge of inspecting medical devices.（10）the standard of inspection is inconsistent between local GMP and import QSD manufacturers.（III）Attitude：（11）the degree of implementation of quality system is inconsistent among manufacturers；（12）no penalty is implemented for manufactories that violate the GMP。

Discussion and suggestion：In light of the globalization of medical device supply, alliance between countries in terms of regulatory policies, and booming free trade agreements, the management of medical device is moving toward mutual recognition and give-and-take policy between countries. Therefore, how to ensure the quality of medical devices and improve the management system for medical devices will be critical in the future. The study makes following suggestions to stakeholders of the quality of medical devices:（I）the government should improve the management of the life cycle of medical devices, strive for mutual recognition between countries in medical device certification, elevate the TFDA expert knowledge on medical devices, and enforce regulation policies.（II）the medical device manufacturers should elevate enterprise responsibility, acquire research and development capability and be amenable to regulation.（III）medical device user：Educate user and supervise the quality of medical device. As authorities pursue competitiveness in marketing medical devices internationally, ensuring the quality of medical devices should be the top priority.

並列關鍵字

Medical Device ； Quality System Regulation ； GMP ； ISO13485

參考文獻

Cristea, L., Baritz, M., Cotoros, D., & Repanovici, A. (2008). Aspects of quality assurance in medical devices production.

洪于淇. (2009). 全民健保部分給付制度下塗藥血管支架價格影響因素分析. 國立台灣大學衛生政策與管理研究所碩士論文.

楊裕熙 (2007). ISO 13485: 2003 醫療器材品質管理系統之探討. 品質月刊, 43(11), 72-78.

賴柏樺, 全球醫療器材管理模式之研究, 中華民國品質學會第38 屆年會暨第8 屆全國品質管理研討會

吳亭瑤、吳正寧、馬.秋舜、杜培文、鄒玫君.（2005）.市售橡膠醫用手套針孔及水溶性蛋白含量試驗之品質調查，藥物食品檢驗局調查研究年報. 23：6-13.