| Summary: | 碩士 === 國立臺灣大學 === 健康政策與管理研究所 === 99 === 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.
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