篇名

鳥瞰臺灣醫療器材之規範:以醫療器材管理法草案為中心   免費試閱

並列篇名

An Overview of Taiwan's Regulations on Medical Device: The Focus of Draft Medical Device Act

作者
中文摘要

臺灣醫療器材管理規定,係規範於藥事法及相關子法,此乃因醫療器材屬藥事法中所稱之「藥物」。鑑於醫療器材與藥品的風險及管理未必相同,且近年臺灣醫療器材產業蓬勃發展,藥事法之規範漸難以因應多元需求,為此,衛生福利部遂參酌國外立法例並兼顧臺灣產業之發展趨勢,於2016年12月5日公布醫療器材管理法草案。本文擬探究現行藥事法之體例,分析目前醫療器材管理制度之架構與運作,再以研擬中草案為對象,探討草案與現行制度之異同,俾對醫療器材法制變革及修法動向提供整體之輪廓。

英文摘要

In Taiwan, the regulations relating to management of medical device are set forth in the Pharmaceutical Affairs Act and its sub-laws; where medical devices are defined as “medicaments.” Given the fact that the management of medical devices and the risks associated therewith may not be the same as that of drugs, and that the existing Pharmaceutical Affairs Act are insufficient to deal with the complex and diverse needs due to the vigorous development of the domestic medical device industry in recent years; the Ministry of Health and Welfare had promulgated the draft Regulations for Governing the Management of Medical Device Act on December 5, 2016, taking into account foreign legislation and the above ─ referenced development of domestic industry. This article aims to explore the structure of the current Pharmaceutical Affairs Act, and to analyze the current medical device management system and operation, in comparison to the draft Regulations for Governing the Management of Medical Device ─ hoping to provide a comprehensive view of the transformation in the system and the proposed changes in law.

起訖頁

023-040

期數
出版單位
DOI

10.3966/241553062018010015002  複製DOI  DOI查詢

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