Regulation for Registration of Medical Devices Article 10
Class I, Class II, and Class III medical devices in this Regulation are determined in accordance with the Regulations for Governing Management of Medical Devices.
中文原文 醫療器材查驗登記審查準則第10條
本準則所稱第一等級、第二等級、第三等級醫療器材，依醫療器材管理辦法之分級規定。