Medical Devices Act Article 30
Medical device product items designated by the central competent authority shall comply with specific specifications and performance.The product items, specifications, test methods, and performance of medical devices referred to in the preceding paragraph shall be announced by the central competent authority. If a test method has not been established, an internationally recognized method may be adopted; if there is no internationally recognized test method, the suitability thereof shall be demonstrated.
中文原文 醫療器材管理法第30條
經中央主管機關指定品項之醫療器材，應符合特定之規格及性能。
前項醫療器材之品項、規格、檢驗方法及性能，由中央主管機關公告之；未定檢驗方法者，得依國際間認可之方法為之；如未有國際間認可之檢驗方法者，應予以證實其合適性。
前項醫療器材之品項、規格、檢驗方法及性能，由中央主管機關公告之；未定檢驗方法者，得依國際間認可之方法為之；如未有國際間認可之檢驗方法者，應予以證實其合適性。