篇名

醫療器材管理法概覽

並列篇名

Overviews of Medical Devices Act

中文摘要

衛生福利部食品藥物管理署自2014年起著手規劃「醫療器材管理法」架構及法制面之評估,草案條文於2016年12月5日對外公告周知,並於2019年12月13日經立法院三讀通過,2020年1月15日由總統公布。本文將從醫療器材管理法推動歷程、立法效益、規範架構及重點進行說明,並介紹本法新制度亮點。透過本法之制定與施行,將保障消費者權益,降低國際法規障礙,提升醫療器材產業國際競爭力,為臺灣醫療器材產業開創多贏局面。

英文摘要

The Food and Drug Administration under the Ministry of Health and Welfare (hereinafter referred to as the “FDA”) has been planning the structure of the “Medical Devices Act” and has conducted an evaluation of the legal system since 2014. The draft provisions were publicly announced on December 5, 2016, passed on the third reading on December 13, 2019, and announced by the President on January 15, 2020. This article will explain the promotion process, legislative benefits, regulatory framework and focuses of the Medical Devices Act, and introduce the highlights of the new system built upon this Act. The formulation and implementation of this Act will protect consumer rights, reduce barriers of international regulations, and enhance the international competitiveness of the medical device industry, thus creating a win-win situation for the medical device industry in Taiwan.

起訖頁

007-016

出版單位
DOI

10.3966/241553062020060044001  複製DOI  DOI查詢

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