智慧醫療器材之監管規範──美國智慧醫療器材監管趨勢之借鑑

Regulations of Smart Medical Device-Reference from the Trends of Regulations for Smart Medical Device in the U.S.A.

智慧醫療已大幅改變過去傳統之醫療照護模式，結合人工智慧技術的智慧醫療產品，可能以軟體或應用程式的形式出現，其與傳統醫療器材在本質上可能有很大的不同，主管機關對於此類智慧醫療產品進入市場前後的監管，應有如何之監管機制，成為各國競逐智慧醫療領域產業的重要課題。我國在2021年5月1日起正式施行「醫療器材管理法」，以衛生福利部食品藥物管理署為主管機關，協助產業了解與因應新法規與監管機制，促使國人獲得高品質、安全且有效的醫材產品，衛福部亦公告有數個相關之技術與法規指引。然而，醫療產業必須放眼於全球，醫療產品是否能進入各國市場競爭，也將受到各國的監管機制的檢驗，因此，對於他國的法規範與監管機制運行之了解勢在必行。
美國FDA傳統上對於醫療器材採取嚴格的監管制度，但伴隨醫療科技與人工智慧技術的進步，在產業及國會的推動下，透過21世紀醫療法案的修訂，修改醫療器材的定義，並透過許多醫療軟體規範的指引說明，逐步釐清其對於醫療軟體的監管範圍。本文梳理美國關於醫療器材之法律規定與美國FDA所發布之指南及計畫，並比較我國關於智慧醫療器材之相關法規與指引，借鑑他山之石，期許我國智慧醫療器材法規範與產業亦能與國際接軌。

E-Health has revolutionized the conventional healthcare model. Smart medical products powered by artificial intelligence often appear in the form of software or apps, differ substantially from traditional medical devices. The regulation of these smart medical products both pre and post-market entry has become a critical concern for countries vying in this sector. Taiwan's Food and Drug Administration, under the Ministry of Health and Welfare, took a proactive step by implementing the ''Medical Device Act'' on May 1, 2021. It is committed to assisting the industry in comprehending and adhering to the new laws and regulations, ensuring the availability of high-quality, safe, and effective medical products. To this end, they have released several technical and regulatory guidelines.
However, the medical industry must have a broader outlook on the global landscape. Medical products seeking to compete in international markets must navigate the regulatory frameworks of those countries. Thus, understanding the regulatory operations of other nations is imperative.
However, in response to advancements in medical technology and artificial intelligence, and driven by industry and congressional initiatives, the 21st Century Cures Act has expanded and clarified the regulation of medical software. This act, along with numerous guidelines, addresses the specifications of medical software. This article underscores the U.S. laws and regulations on medical devices and the guidelines and programs issued by the U.S. FDA, and compares them with the laws, regulations and guidelines governing smart medical devices in Taiwan. The aim is to align Taiwan's regulations and industry practices with international standards, fostering compliance and competitiveness on the global stage.