A Study of the Premarket Regulations on Medical Devices in the United States, European Union and Taiwan

• Main Authors: Cheng-Hsiung Wang, 王正雄
• Other Authors: Chin-Chieh Yang
• Format: Others
• Language: zh-TW
• Published: 2014
• Online Access: http://ndltd.ncl.edu.tw/handle/23835693123820504492

碩士 === 國立雲林科技大學 === 科技法律研究所 === 102 === The premarket review system of medical devices is a procedure that regulates all medical devices before they are offered to the public. In accordance with this procedure, medical devices must be reviewed to confirm their regulatory compliance with health authorities before the devices are marketed and sold. Because (1) the objectives of medical devices are their safety and effectiveness and (2) the marketing of a defective medical device would cause wide-ranging impact, many countries have established regulations and regulatory frameworks concerning medical devices. The resulting procedures are based on either the protocols used in United States or the system employed by the European Commission system to facilitate a premarket review process of medical devices. In Taiwan, the Taiwan Food and Drug Administration (TFDA) has guidelines in place for the premarket regulation of medical devices. However, many local Taiwanese medical device manufacturers run both domestic and overseas business, so these manufactures frequently struggle with the discrepancies among the premarket regulation requirements enforced in Taiwan and the countries of Europe and North America. This thesis begins with an introduction of medical device premarket regulations, focusing on the regulatory systems of the United States, the European Commission, and Taiwan. Next, this thesis compares and contrasts the similarities and differences among these three systems to identify potential solutions to the current problems inherent in the premarket regulations of medical devices manufactured in Taiwan. The contents and conclusions of this thesis should serve as valuable reference for Taiwan health authorities concerning the premarket review of medical devices produced in Taiwan.