Regulation for Registration of Medical Devices Article 34
Application for extension of the validity period of a medical device permit license shall be made within six months of the expiration. Those who fail to apply for an extension before the deadline must re-apply for registration and market approval, and may not submit extension applications. However, in the case of Class II and Class III medical device, the re-applying registration may be applied with following documents within six months after the expiration of the original permit license:1.One copy of each the original and photocopy of the medical device registration and market approval application form.2.Photocopy of the pharmaceutical firm permit license as a domestic medical device manufacturer, or an imported medical device dealer.3.Photocopy of the originally-approved medical device permit license.4.Photocopy of the already approved instruction leaflet and labels stamped with tally impression of the central health competent authority.5.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.6.The original copy of the manufacture and free sale certificate of the country of origin.7.Original copy of foreign original manufacturer continual authorization letter.8.Documents verifying that the manufacturing factory in conformity with the GMP for Medical Devices. The medical device applying for foregoing paragraph registration is commissioned to manufacture or analysis, it shall be in conformity with the Regulations for Medicament Contract Manufacture and Analysis.In the event of domestic Class II or Class III medical device applying for registration according to the proviso of Paragraph 1, is exempted from submitting documents specified in Subparagraph 6 and 7 of Paragraph 1.
中文原文 醫療器材查驗登記審查準則第34條
醫療器材許可證有效期間之展延，應於期滿前六個月內申請；逾期者，應重新申請查驗登記，不受理其展延申請。
但第二等級、第三等級醫療器材得於原許可證有效期間屆滿後六個月內，檢附下列資料重新申請查驗登記：
一、醫療器材查驗登記申請書正、副本各一份。
二、國產醫療器材製造業或輸入醫療器材販賣業藥商許可執照影本一份。
三、原核准之醫療器材許可證影本。
四、原核准並蓋有中央衛生主管機關騎縫章之仿單標籤核定本影本。
五、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。
六、出產國許可製售證明正本。
七、國外原廠繼續授權登記書正本。
八、該製造廠符合醫療器材優良製造規範之證明文件。
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。
第一項但書屬國產第二等級、第三等級醫療器材者，免附該項第六款及第七款資料。
但第二等級、第三等級醫療器材得於原許可證有效期間屆滿後六個月內，檢附下列資料重新申請查驗登記：
一、醫療器材查驗登記申請書正、副本各一份。
二、國產醫療器材製造業或輸入醫療器材販賣業藥商許可執照影本一份。
三、原核准之醫療器材許可證影本。
四、原核准並蓋有中央衛生主管機關騎縫章之仿單標籤核定本影本。
五、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。
六、出產國許可製售證明正本。
七、國外原廠繼續授權登記書正本。
八、該製造廠符合醫療器材優良製造規範之證明文件。
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。
第一項但書屬國產第二等級、第三等級醫療器材者，免附該項第六款及第七款資料。