Regulation for Registration of Medical Devices Article 35
The following documents shall be attached when applying for extension of the validity period of a medical device permit license:1.A medical device permit license validity period extension application form approved by the special municipality, county and city health competent authority of the pharmaceutical company's locality.2.Original copy of the medical device permit license.3.The original copy of the manufacture and free sale certificate of the country of origin.4.Original copy of foreign original manufacturer continual authorization letter.5.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.The medical device applying for foregoing paragraph application is commissioned to manufacture or analysis, it shall be in conformity with the Regulations for Medicament Contract Manufacture and Analysis.In the event of applying for extension of the validity period of a medical device permit license for a domestically manufactured medical device, the applicant is exempted from submitting documents specified in Subparagraph 3 and 4 of Paragraph 1.In the event of applying extension of the validity period of a medical device permit license of a Class I medical device, in addition to complying this article, Articles 14 and 16 shall be applied mutatis mutandis.If meeting one of the following circumstances, documents of the Subparagraphs 5 in the Paragraph 1 may be substituted with photocopies of documents verifying compliance with GMP for Pharmaceuticals:1.The medical device applying for registration was regulated as a 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 manufacturing factory with valid medical device license shall not be approved for extension if it fails to conform to the GMP for medical device.For the application for extension of a permit license in accordance with Paragraph 1, the central health competent authority may order submission of relevant documents if there are doubts about the safety and efficacy of the product concerned.
中文原文 醫療器材查驗登記審查準則第35條
申請展延醫療器材許可證有效期間，應檢附下列資料：
一、經藥商所在地之直轄市或縣（市）衛生主管機關核章之醫療器材輸入（製造）許可證有效期間展延申請書。
二、原許可證正本。
三、出產國許可製售證明正本。
四、國外原廠繼續授權登記書正本。
五、該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。
前項醫療器材屬委託製造或檢驗者，應符合藥物委託製造及檢驗作業準則之規定。
如係申請展延國產醫療器材許可證者，免附第一項第三款及第四款資料。
如係申請展延第一等級醫療器材許可證者，除適用本條規定外，得準用第十四條及第十六條規定辦理。
第一項第五款資料，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、申請展延許可證之醫療器材原列屬藥品管理者，得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已領有醫療器材許可證之製造廠，如不符合醫療器材優良製造規範者，其許可證不准展延。
依第一項規定辦理許可證展延申請，如涉有產品安全效能疑慮者，中央衛生主管機關得命提出相關資料。
一、經藥商所在地之直轄市或縣（市）衛生主管機關核章之醫療器材輸入（製造）許可證有效期間展延申請書。
二、原許可證正本。
三、出產國許可製售證明正本。
四、國外原廠繼續授權登記書正本。
五、該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。
前項醫療器材屬委託製造或檢驗者，應符合藥物委託製造及檢驗作業準則之規定。
如係申請展延國產醫療器材許可證者，免附第一項第三款及第四款資料。
如係申請展延第一等級醫療器材許可證者，除適用本條規定外，得準用第十四條及第十六條規定辦理。
第一項第五款資料，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、申請展延許可證之醫療器材原列屬藥品管理者，得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已領有醫療器材許可證之製造廠，如不符合醫療器材優良製造規範者，其許可證不准展延。
依第一項規定辦理許可證展延申請，如涉有產品安全效能疑慮者，中央衛生主管機關得命提出相關資料。