Regulations for the Inspection and Examination of Imported Medicaments Article 10
For the medical devices required for inspection by the competent authority , the obligatory inspection applicants shall submit the following documents to the inspection authority to carry out the inspection:1. An application form for inspection.2. A copy of medical devices permit license.3. A copy of application for import declaration.4. Necessary documents required by the competent authority.The application of the preceding paragraph can be submitted electronically.Medical devices that conform to one of the following situations can be exempted from inspection:1. Products to be imported are issued with a certificate of examination by the government of the country of origin who has signed an inspection waiver reciprocity agreement with the government of the Republic of China.2. A special permit from central competent health authority granted for national emergency situation or to improve the public welfare.
中文原文 輸入藥物邊境抽查檢驗辦法第10條
輸入經公告應施查驗之醫療器材，應由報驗義務人檢具下列文件，向查驗機關申請查驗：
一、查驗申請書。
二、醫療器材許可證影本。
三、進口報單影本。
四、其他經中央衛生主管機關公告之文件。
前項申請，得以電子方式為之。
第一項之醫療器材有下列情形之一，免予查驗：
一、經互惠免驗優待輸出國主管機關發給檢驗合格證明者。
二、其他為因應國家緊急情況，或增進公益，經中央衛生主管機關專案核准免查驗者。
一、查驗申請書。
二、醫療器材許可證影本。
三、進口報單影本。
四、其他經中央衛生主管機關公告之文件。
前項申請，得以電子方式為之。
第一項之醫療器材有下列情形之一，免予查驗：
一、經互惠免驗優待輸出國主管機關發給檢驗合格證明者。
二、其他為因應國家緊急情況，或增進公益，經中央衛生主管機關專案核准免查驗者。