Regulation for Registration of Medical Devices Article 15
For application of registration and market approval for domestically manufactured Class 2 or Class 3 medical devices, the following documents shall be submitted for review:1.One copy each of the original and photocopy of the medical device registration and market approval application form.2.Two copies of each of the following items: the form for attaching outer box instruction label with all Chinese instruction leaflet catalog packaging, and labeling, instructions for use, and color pictures of the physical appearance of product.3.A photocopy of pharmaceutical firm permit license as a medical device manufacturer.4.Affidavit (A)5.Documents verifying that the domestic manufacturing factory is in conformity with the GMP for Medical Devices.6.One copy of each of the follwing items: pre-clinical testing and the test specifications and methods, the original test records, and the test reports of the quality control conducted by the original manufacturer.7.One copy of each of the relevant documents concerning product structure, materials, specifications, performance, intended uses, and drawings, etc. For instrument products, an operation manual or a service manual covers all of the above-mentioned items may be a substitution.8.Theoretical basis and relevant research reports and data.9.Clinical trial reports.10.Two copies of radiation safety information for equipments generating ionizing radiation.Documents of the Subparagraphs 5 in the preceding paragraph, in accordance with any of the followings, may be substituted with photocopies of documents verifying compliance with the Good Manufacturing Practices for Pharmaceuticals in accordance with the Part 2 of the Pharmaceutical Good Manufacturing Practice Regulations (hereafter referred to as GMP for Pharmaceuticals):1.The medical device applying for registration and market approval was regulated as pharmaceutical product before. This rule applies within three years from the date of proclamations of listing change.2.The medical device was regulated as a pharmaceutical product before January 1, 2013. This rule applies within three years from the promulgation date of the September 5, 2014 amendment to this Regulation.The central health competent authority shall determine or announce whether the medical device applying for registration and market approval requires clinical trials in Taiwan in light of the medical device product item, the case, and the materials submitted.In the event of already a product in the market similar to the medical device applying for registration, except where other regulations apply, the documents specified in Subparagraphs 8 and 9 of Paragraph 1 may be waived. However, the applicant shall additionally attach a domestic clinical trial report when clinical trials in Taiwan are required in accordance with the foregoing Paragraph.In the event of applying for registration and market approval of Class 2 medical devices with no predicate product previously approved to market by the central health competent authority, the documents specified in Subparagraphs 9 of Paragraph 1 may be waived if the medical device is in conformity with the related simplified rules or regulations announced by the central health competent authority. However, a domestic clinical trial report shall be submitted when a domestic clinical trial is required according to Paragraph 3.In the event of applying for registration of medical devices exclusively for export, submissions for testing are not required, and documents required by Subparagraphs 6 to 10 of Paragraph 1 shall be exempted.The registration and market approval of IVDs shall be in conformity with the preceding six paragraphs and announcements by the central health competent authority. For the IVDs listed as Class III according to the Regulations for Governing the Management of Medical Device and required to undergo testing, as announced by the central health competent authority, two (2) copies of the documents specified in Subparagraph 6 of Paragraph 1 shall be submitted, and submission for testing shall be required, except for products exclusively for export.The medical devices applying for Class III registration and market approval, except products exclusively for export, shall also submit documents of Essential Principles (EP) and Summary of Technical Documentation (STED) in accordance with Appendix.In the event of the pharmaceutical firm applying for registration and market approval different from the manufacturer, it shall be deemed as commission manufacturing.In the event of the medical device applying for registration and market approval is commissioned to manufacture or testing, the device shall be in conformity with the preceding nine paragraphs and the Regulations for Medicament Contract Manufacture and Analysis.The medical device applying for registration in Paragraph 1 and Paragraph 6 shall be in conformity with related rules or regulations announced by the central health competent authority, and the documents exempted from submission shall be kept in the manufacturing factory. The central health competent authority may order its submission when necessary.Appendix：Essential Principles (EP), and Summary of Technical Documentation.PDFAppendix：Essential Principles (EP), and Summary of Technical Documentation.doc
中文原文 醫療器材查驗登記審查準則第15條
申請國產第二等級或第三等級醫療器材查驗登記，應檢附下列資料：
一、醫療器材查驗登記申請書正、副本各一份。
二、黏貼或裝釘於標籤黏貼表上之中文仿單目錄、使用說明書、包裝、標籤及產品實際外觀彩色圖片各二份。
三、醫療器材製造業藥商許可執照影本。
四、切結書（甲）。
五、國內製造廠符合醫療器材優良製造規範之證明文件。
六、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一份。
七、產品之結構、材料、規格、性能、用途、圖樣等有關資料一份。
但儀器類之產品，得以涵蓋本款資料之操作手冊及維修手冊替代之。
八、學術理論依據與有關研究報告及資料。
九、臨床試驗報告。
十、發生游離輻射線器材之輻射線防護安全資料二份。
前項第五款資料，符合下列情形之一者，得以符合藥物優良製造準則第二編藥品優良製造規範（下稱藥品優良製造規範）之證明文件影本替代之。
一、申請查驗登記之醫療器材原列屬藥品管理者，於公告改列醫療器材之日起三年內。
二、中華民國一百零二年一月一日前原屬藥品並經公告改列為醫療器材管理者，自本準則一百零三年九月五日修正發布日起三年內。
申請查驗登記之醫療器材應否在國內進行臨床試驗，另由中央衛生主管機關視申請之醫療器材品項、個案及申請人檢送之資料核辦或公告。
申請查驗登記之醫療器材已有類似品經中央衛生主管機關核准上市者，除另有規定外，得免附第一項第八款及第九款資料。
但依前項規定須在國內進行臨床試驗者，應另附國內臨床試驗報告。
申請查驗登記之醫療器材如係第二等級且無類似品經中央衛生主管機關核准上市，但符合中央衛生主管機關公告之相關簡化規定者，得免附第一項第九款資料。
但依第三項規定須在國內進行臨床試驗者，應另附國內臨床試驗報告。
申請查驗登記之醫療器材如係專供外銷之用者，無須辦理送驗，並得免附第一項第六款至第十款資料。
體外診斷醫療器材之查驗登記，應依前六項規定及中央衛生主管機關公告事項辦理；列屬醫療器材管理辦法第三等級經中央衛生主管機關公告應辦理檢驗之體外診斷醫療器材，除專供外銷之用者外，其第一項第六款資料應檢附二份，並應送驗。
申請第三等級醫療器材之查驗登記，除專供外銷之用者外，並應依中央衛生主管機關公告之醫療器材安全性與功效性基本規範及技術文件摘要（如附件）辦理。
申請查驗登記之藥商與製造廠不同時，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，除應依前九項規定辦理外，應符合藥物委託製造及檢驗作業準則之規定。
依第一項及第六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，得免附之資料應留廠備查，必要時，中央衛生主管機關得命提出相關資料。
一、醫療器材查驗登記申請書正、副本各一份。
二、黏貼或裝釘於標籤黏貼表上之中文仿單目錄、使用說明書、包裝、標籤及產品實際外觀彩色圖片各二份。
三、醫療器材製造業藥商許可執照影本。
四、切結書（甲）。
五、國內製造廠符合醫療器材優良製造規範之證明文件。
六、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一份。
七、產品之結構、材料、規格、性能、用途、圖樣等有關資料一份。
但儀器類之產品，得以涵蓋本款資料之操作手冊及維修手冊替代之。
八、學術理論依據與有關研究報告及資料。
九、臨床試驗報告。
十、發生游離輻射線器材之輻射線防護安全資料二份。
前項第五款資料，符合下列情形之一者，得以符合藥物優良製造準則第二編藥品優良製造規範（下稱藥品優良製造規範）之證明文件影本替代之。
一、申請查驗登記之醫療器材原列屬藥品管理者，於公告改列醫療器材之日起三年內。
二、中華民國一百零二年一月一日前原屬藥品並經公告改列為醫療器材管理者，自本準則一百零三年九月五日修正發布日起三年內。
申請查驗登記之醫療器材應否在國內進行臨床試驗，另由中央衛生主管機關視申請之醫療器材品項、個案及申請人檢送之資料核辦或公告。
申請查驗登記之醫療器材已有類似品經中央衛生主管機關核准上市者，除另有規定外，得免附第一項第八款及第九款資料。
但依前項規定須在國內進行臨床試驗者，應另附國內臨床試驗報告。
申請查驗登記之醫療器材如係第二等級且無類似品經中央衛生主管機關核准上市，但符合中央衛生主管機關公告之相關簡化規定者，得免附第一項第九款資料。
但依第三項規定須在國內進行臨床試驗者，應另附國內臨床試驗報告。
申請查驗登記之醫療器材如係專供外銷之用者，無須辦理送驗，並得免附第一項第六款至第十款資料。
體外診斷醫療器材之查驗登記，應依前六項規定及中央衛生主管機關公告事項辦理；列屬醫療器材管理辦法第三等級經中央衛生主管機關公告應辦理檢驗之體外診斷醫療器材，除專供外銷之用者外，其第一項第六款資料應檢附二份，並應送驗。
申請第三等級醫療器材之查驗登記，除專供外銷之用者外，並應依中央衛生主管機關公告之醫療器材安全性與功效性基本規範及技術文件摘要（如附件）辦理。
申請查驗登記之藥商與製造廠不同時，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，除應依前九項規定辦理外，應符合藥物委託製造及檢驗作業準則之規定。
依第一項及第六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，得免附之資料應留廠備查，必要時，中央衛生主管機關得命提出相關資料。