Medical Devices Act Article 3
The term "medical devices", as used in this Act, shall refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:1. Diagnosis, treatment, alleviation, or direct prevention of human diseases.2. Modification or improvement of the structure and function of human body.3. Control of conception.Regulations governing the categories, risk classification, items, determination principles, and other related shall be established by the central competent authority.Assistive devices covered by Subparagraph 2 of Paragraph 1 that are non-invasive, not expected to cause harm to the health of human body, and used without the assistance of medical personnel may be notified to the central competent authority for approval and exempt from being listed as medical devices of the preceding paragraph.Assistive devices set forth in the preceding paragraph refer to appliances, equipment, instruments, and software that assist physically or mentally disabled persons to improve or maintain physical function and structure, to facilitate activity and participation, or to provide convenience to the attendance of their caregivers.
中文原文 醫療器材管理法第3條
本法所稱醫療器材，指儀器、器械、用具、物質、軟體、體外診斷試劑及其相關物品，其設計及使用係以藥理、免疫、代謝或化學以外之方法作用於人體，而達成下列主要功能之一者：
一、診斷、治療、緩解或直接預防人類疾病。
二、調節或改善人體結構及機能。
三、調節生育。
前項醫療器材之分類、風險分級、品項、判定原則及其他相關事項之辦法，由中央主管機關定之。
第一項第二款屬非侵入性、無危害人體健康之虞及使用時毋需醫事人員協助之輔具，得報請中央主管機關核准，免列為前項醫療器材之品項。
前項輔具係指協助身心障礙者改善或維護身體功能、構造，促進活動及參與，或便利其照顧者照顧之裝置、設備、儀器及軟體等產品。
一、診斷、治療、緩解或直接預防人類疾病。
二、調節或改善人體結構及機能。
三、調節生育。
前項醫療器材之分類、風險分級、品項、判定原則及其他相關事項之辦法，由中央主管機關定之。
第一項第二款屬非侵入性、無危害人體健康之虞及使用時毋需醫事人員協助之輔具，得報請中央主管機關核准，免列為前項醫療器材之品項。
前項輔具係指協助身心障礙者改善或維護身體功能、構造，促進活動及參與，或便利其照顧者照顧之裝置、設備、儀器及軟體等產品。