Regulation for Registration of Medical Devices Article 16
For application of registration and market approval for imported Class I medical device, the following documents shall be submitted:1.Application form for Class I medical device registration and market approval and original copy of affidavit.2.A photocopy of pharmaceutical firm permit license as a medical device dealer.3.Certificate of in conformity with the GMP for Medical Devices. Product items in accordance with the Article 4 Appendix II of the Regulations for Governing the Management of Medical Device are exempted from this subparagraph.If the medical device applying for registration and market approval is commissioned to manufacture or analysis, it shall be in conformity with the Regulations for Medicament Contract Manufacture and Analysis.The medical device applying for registration in the Paragraph 1 shall be in conformity with related rules or regulations announced by the central health competent authority, and the following technical documentation of the device shall be kept in the manufacturing factory for inspection: instruction leaflets, the original instruction for use with a copy of its Chinese translation, packaging, labels of the medical device, and documents with the information of the product such as structure, materials, specifications, performance, intended use, drawing and others, and documents of pre-clinical testing, and the testing results of quality control of the original manufacturer. The central health competent authority may order its submission when necessary.The registration and market approval application filed in accordance with Paragraph 1 may be submitted in writing or online. In the case of submission in writing, the applicant shall sign or affix its seal to the application form. In the case of submission online, the IC card issued by the Certificate Authority of the Ministry of Economic Affairs shall be used, and the documents set forth in Subparagraphs 1 and 2 of Paragraph 1 may not be required.
中文原文 醫療器材查驗登記審查準則第16條
申請輸入第一等級醫療器材查驗登記，應檢附下列資料：
一、第一等級醫療器材查驗登記申請暨切結書正本。
二、醫療器材販賣業藥商許可執照影本。
三、製造廠符合醫療器材優良製造規範之證明文件。
但依醫療器材管理辦法規定，適用醫療器材優良製造規範精要模式之品項，免附本款資料。
申請查驗登記之醫療器材如係委託製造或檢驗者，應符合藥物委託製造及檢驗作業準則之規定。
依第一項規定辦理查驗登記之醫療器材，應符合中央衛生主管機關公告之相關規定，其仿單目錄、使用說明書及其詳細中文譯稿、包裝、標籤、產品之結構、材料、規格、性能、用途、圖樣等相關資料、臨床前測試及原廠品質管制之檢驗資料等技術性文件應留廠備查，必要時，中央衛生主管機關得命提出相關資料。
依第一項規定辦理查驗登記，得以書面或網路為之。
以書面申請者，申請書應由申請商簽章；以網路申請者，應以經濟部工商憑證管理中心簽發之工商憑證為之，並得免附第一項第一款、第二款資料。
一、第一等級醫療器材查驗登記申請暨切結書正本。
二、醫療器材販賣業藥商許可執照影本。
三、製造廠符合醫療器材優良製造規範之證明文件。
但依醫療器材管理辦法規定，適用醫療器材優良製造規範精要模式之品項，免附本款資料。
申請查驗登記之醫療器材如係委託製造或檢驗者，應符合藥物委託製造及檢驗作業準則之規定。
依第一項規定辦理查驗登記之醫療器材，應符合中央衛生主管機關公告之相關規定，其仿單目錄、使用說明書及其詳細中文譯稿、包裝、標籤、產品之結構、材料、規格、性能、用途、圖樣等相關資料、臨床前測試及原廠品質管制之檢驗資料等技術性文件應留廠備查，必要時，中央衛生主管機關得命提出相關資料。
依第一項規定辦理查驗登記，得以書面或網路為之。
以書面申請者，申請書應由申請商簽章；以網路申請者，應以經濟部工商憑證管理中心簽發之工商憑證為之，並得免附第一項第一款、第二款資料。