Regulation for Registration of Medical Devices Article 14
For application of registration and market approval of domestically manufactured Class 1 medical devices, the following documents shall be submitted for review:1. Application form for Class 1 medical device registration and market approval and original copy of affidavit.2.A photocopy of pharmaceutical firm permit license as a medical device manufacturer.3.Documents verifying that the manufactory in conformity with the Good Manufacturing Practices for Medical Devices in accordance with the Part 3 of the Pharmaceutical Good Manufacturing Practice Regulations (hereafter referred to as 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.In the event of the pharmaceutical firm applying for registration different from the manufacturer, it shall be deemed as commission manufacturing.The medical device applying for registration 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 Paragraph 1 shall be in conformity with proclamations of the central health competent authority; and the technical documentation of the device shall be kept in the manufactory for inspection, which including: the Chinese instruction leaflet, instruction for use, packaging, labels of the medical device, and documents with the product information such as construction, material, specification, efficacy, purpose, drawing and others, and documents of pre-clinical trial, and inspection results of quality control of original manufacturer. The central health competent authority may order its submission if 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 applying pharmaceutical firm 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14條
申請國產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、醫療器材製造業藥商許可執照影本。
三、製造廠符合藥物優良製造準則第三編醫療器材優良製造規範（下稱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。
申請查驗登記之藥商與製造廠商不同時，視為委託製造關係。
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，其中文仿單目錄、使用說明書、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，申請書應由申請藥商簽章；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、醫療器材製造業藥商許可執照影本。
三、製造廠符合藥物優良製造準則第三編醫療器材優良製造規範（下稱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。
申請查驗登記之藥商與製造廠商不同時，視為委託製造關係。
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，其中文仿單目錄、使用說明書、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，申請書應由申請藥商簽章；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。