剖析醫療器材管理法草案：醫療器材定義之修法問題探討【本期企劃】 試閱
An Analysis of the Draft of the Taiwan Medical Device Supervision Act: Reviewing the Revisions to the Definition of ‘Medical Device’
衛生福利部於2016年公告醫療器材管理法草案，確立以專法規範的立法方向，以因應醫療器材及藥品分流管理之國際趨勢與需求，具有指標性意義。其中，醫療器材之定義，不僅為適用醫療器材管理法之前提要件，也是銜接國際醫療法規之重要橋梁，有助於推動臺灣相關產業國際競爭力與減少國際貿易障礙。惟若細繹條文內容，仍有諸多未明之處，故本文擬就醫療器材之特性並自比較法之觀點，就草案內容提供初步意見，提供給各界參考，以完善法規制度並推動醫療器材之發展創新，促進國民健康之福祉。
The draft of the Taiwan Medical Device Supervision Act (TMDSA), promulgated in December of 2016, is a landmark proposal in the pharmaceutical regulatory system of Taiwan. The Taiwan Food and Drug Administration (TFDA) will now regulate medical devices within the territory of the Republic of China (Taiwan) under an individual and separate rules, separate from the current Pharmaceutical Act. The definition of ‘medical devices’ in the TMDSA is important as it will determine whether or not any such device falls under the scope of the TMDSA or the Pharmaceutical Act. Unfortunately, the wording of the definition of ‘medical devices’ in the TMDSA remains very vague and ambiguous – and could use further revision. In this article, we examine the laws and regulations of first world countries around the globe and how Taiwan may better revise its medical device law, and definitions, in order to improve domestic and global health.
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