首頁 »
August 9, 2016

申請輸入第二等級或第三等級醫療器材查驗登記


條文
友善列印
名  稱 醫療器材查驗登記審查準則 英
修正日期 民國 103 年 09 月 05 日
法規類別 行政 > 衛生福利部 > 食品藥物管理目

第 17 條
申請輸入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仿單目錄、使用說明書及其詳細中文譯
稿、包裝、標籤及產品實際外觀彩色圖片各二份。
三、醫療器材販賣業藥商許可執照影本一份。
四、切結書(甲)。
五、出產國許可製售證明正本。
六、國外原廠授權登記書正本。
七、輸入醫療器材製造廠符合醫療器材優良製造規範之證明文件。
八、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。
九、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。
十、學術理論依據與有關研究報告及資料。
十一、臨床試驗報告。
十二、發生游離輻射線器材之輻射線防護安全資料二份。
前項第七款資料,如符合下列情形之一者,得以符合藥品優良製造規範之
證明文件影本替代之:
一、如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 103 年 9 月 5 日修正發布日起三年內。
申請查驗登記之醫療器材應否在我國進行臨床試驗,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,得免附第一項第十款及第十一款資料。但依前項規定須在我
國進行臨床試驗者,應另附我國臨床試驗報告。
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
第十一款資料。但依第三項規定須在我國進行臨床試驗者,應另附我國臨
床試驗報告。
體外診斷醫療器材之查驗登記,應依前五項規定,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,並應送驗。
申請第三等級醫療器材之查驗登記,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。
申請查驗登記之醫療器材如係委託製造或檢驗者,除應依前七項規定辦理
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。
附 檔
附件:醫療器材安全性與功效性基本規範及技術文件摘要.DOC

http://law.moj.gov.tw/LawClass/LawSingleIf.aspx?Pcode=L0030055&FLNO=17
http://www.fda.gov.tw/TC/law.aspx?cid=55&cchk=f2d99f85-142b-4517-86c1-571ecbb15758

Article 17 For application of registration and market approval for imported Class II or Class III medical devices, the following document shall be submitted for review:
1.One copy of 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 affixed or stapled to the label attachment form of instructions and manual with detailed Chinese translations, packaging, labels and color pictures of the physical appearance of product.
3.A photocopy of pharmaceutical firm permit license as a medical device dealer.
4.Affidavit (A)
5.The original copy of the manufacture and free sale certificate of the country of origin.
6.The original copy of the foreign original manufacturer authorization letter.
7.Documents verifying that the domestic manufacturing factory in conformity with the GMP for Medical Devices.
8.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.
9.One copy of each of the relevant documents concerning product structure, materials, specifications, performance, intended uses, and drawings, etc. For instrument product, an operation manual or a service manual covers all of the above-mentioned items may be a substitution.
10.Theoretical basis and relevant research reports and data.
11.Clinical trial reports.
12.Two copies of radiation safety information for equipment generating ionizing radiation.
Documents of the Subparagraphs 7 in the preceding paragraph, in accordance with any of the followings, may be substituted with photocopies of documents verifying compliance with the 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 10 and 11 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 11 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.
IVD applying for registration and market approval shall be in conformity with the preceding five paragraphs and proclamations by the central health competent authority; IVDs listed as Class III according to the Regulations for Governing the Management of Medical Device and announced as the item required testing by the central health competent authority shall also submit for testing.
The Class III medical device applying for registration and market approval, shall submit documents of Essential Principles (EP) and Summary of Technical Documentation (STED) in accordance with Appendix.
In the event of the medical device applying for registration is commissioned to manufacture or analysis, in addition to conformity with the preceding seven paragraphs, conformity with the Regulations for Medicament Contract Manufacture and Analysis shall also be required.
The medical device applying for registration according to the Paragraph 1 shall be in conformity with related rules or regulations announced by the central health competent authority; document exempted from submission shall be kept at the manufacturing factory for possible inspection, The medical device applying for registration and market approval in the Paragraph 1 shall be in conformity with related rules or regulations announced by the central health competent authority, and documents exempted from submission shall be kept. The central health competent authority may order its submission when necessary.

http://law.moj.gov.tw/Eng/LawClass/LawAll.aspx?PCode=L0030055



違法盤查可以達到「制裁、報復、羞辱」的功能←上一篇 │首頁│ 下一篇→DoNotPay「機器人律師」