Regulation for Registration of Medical Devices Article 5
In any of the following situations, the application shall be disapproved: 1.Fees have not been paid in accordance with regulations, or attached materials are incomplete, or are inconsistent with the contents of the application.2.The applicant has failed to collect the permit license or to submit samples for testing by the designated deadline, or the samples submitted for testing do not meet requirements.3.The applicant has failed to publish, revise, or change the packaging, labeling, or instruction leaflet of the medical devices in accordance with regulations.4.The medical device under application is considered to be hazardous to human health, or raises safety, quality, or efficacy concerns.5.Other situations in nonconformity with this Regulation, other related laws or regulations, or proclamations of the central health competent authority.
中文原文 醫療器材查驗登記審查準則第5條
申請案件有下列情形之一者，不予核准：
一、未依規定繳納費用或檢附之資料不充足或與申請案件內容不符者。
二、未於規定期限內辦理領證或送驗手續，或送驗之樣品經檢驗不合格者。
三、未依規定刊載、修正或變更醫療器材之包裝、標籤或仿單者。
四、申請之醫療器材有損人體健康，或有安全、品質或效能之疑慮者。
五、其他不符本準則或有關法令規定，或不符中央衛生主管機關公告事項規定之情形者。
一、未依規定繳納費用或檢附之資料不充足或與申請案件內容不符者。
二、未於規定期限內辦理領證或送驗手續，或送驗之樣品經檢驗不合格者。
三、未依規定刊載、修正或變更醫療器材之包裝、標籤或仿單者。
四、申請之醫療器材有損人體健康，或有安全、品質或效能之疑慮者。
五、其他不符本準則或有關法令規定，或不符中央衛生主管機關公告事項規定之情形者。