Regulation for Registration of Medical Devices Article 12
Pre-clinical testing and the test specifications and methods, the original test records, and the test reports for the quality control conducted by the original manufacturer, referred to in this Regulation, include documents of safety and functional testing for ensuring the claimed indication for use, structure, materials, design, and quality of the product.For applying the registration, the change of specification or indication for use for a Class II medical device with a predicate product approved to market by the central health competent authority, documents in the preceding paragraph may be substituted by any of the following document:1.A certificate of market approval issued by the government or other competent authority of the United States of America, and any member state of the European Union. The efficacy and indication of the device should be consistent with those described in the above-mentioned certificate.2.An affidavit of pre-clinical testing document in conformity with the proclaimed items of the central health competent authority.Application document in the preceding paragraph exempted from submitting shall be kept in the plant for possible inspection. The central health competent authority may order its submission when necessary.The commissioned laboratory responsible for inspection in Paragraph 1 shall carry out biocompatibility, electrical safety, and electromagnetic compatibility (EMC) tests in conformity with any of the following:1.ISO/ IEC 17025.2.Good Laboratory Practice for Nonclinical Laboratory Studies (GLP).
中文原文 醫療器材查驗登記審查準則第12條
本準則所定臨床前測試及原廠品質管制之檢驗規格與方法、原始檢驗紀錄及檢驗成績書，包括為確保產品宣稱效能、結構、材質、設計及品質所進行之安全性及功能性檢測等資料。
申請第二等級醫療器材查驗登記、變更規格或效能之登記，如有類似品經中央衛生主管機關核准上市者，得以下列文件之一替代前項資料：
一、經美國官方及歐盟會員國之官方或權責機關出具之核准上市證明文件，其產品效能及用途應符合前開機關之核准範圍。
二、符合中央衛生主管機關公告品項之臨床前測試資料切結書。
依前項規定申請者，得免附之第一項資料應留廠備查，必要時，中央衛生主管機關得命其提出。
執行第一項檢測之受託實驗室，執行生物相容性、電性安全性、電磁相容性檢測及無菌性試驗，應符合下列條件之一：
一、符合ISO／IEC17025之規定。
二、符合藥物非臨床試驗優良操作規範（GLP）之規定。
申請第二等級醫療器材查驗登記、變更規格或效能之登記，如有類似品經中央衛生主管機關核准上市者，得以下列文件之一替代前項資料：
一、經美國官方及歐盟會員國之官方或權責機關出具之核准上市證明文件，其產品效能及用途應符合前開機關之核准範圍。
二、符合中央衛生主管機關公告品項之臨床前測試資料切結書。
依前項規定申請者，得免附之第一項資料應留廠備查，必要時，中央衛生主管機關得命其提出。
執行第一項檢測之受託實驗室，執行生物相容性、電性安全性、電磁相容性檢測及無菌性試驗，應符合下列條件之一：
一、符合ISO／IEC17025之規定。
二、符合藥物非臨床試驗優良操作規範（GLP）之規定。