Pharmaceutical Affairs Act Article 13
The term “medical devices,” as used in this Act, shall refer to any instruments, machines, apparatus, materials, software, reagent for in vitro use, and other similar or related articles that are used in diagnosing, treating, alleviating, or directly preventing human diseases, regulating fertility, or which may affect the body structure or functions of human beings, and do not achieve its primary intended action by pharmacological, immunological or metabolic means in or on the human body.The central competent health authority shall establish regulations governing the management of medical devices in regard to their scope, classification, management, and other matters in accordance with practical needs.
中文原文 藥事法第13條
本法所稱醫療器材，係用於診斷、治療、減輕、直接預防人類疾病、調節生育，或足以影響人類身體結構及機能，且非以藥理、免疫或代謝方法作用於人體，以達成其主要功能之儀器、器械、用具、物質、軟體、體外試劑及其相關物品。
前項醫療器材，中央衛生主管機關應視實際需要，就其範圍、種類、管理及其他應管理事項，訂定醫療器材管理辦法規範之。
前項醫療器材，中央衛生主管機關應視實際需要，就其範圍、種類、管理及其他應管理事項，訂定醫療器材管理辦法規範之。