Medical Devices Act Article 57
In case the defective medical devices seized are domestically manufactured and may, after inspection or testing, still be usable through modification, the municipal or county (city) competent authority shall assign officials to supervise the original manufacturer in carrying out the modification within a time period. Those that cannot be modified or are not modified within the time period shall be confiscated and destroyed. Imported defective medical devices shall be immediately placed in confinement, and the municipal or county (city) competent authority shall order the original importer to return and export such devices within a time period. Those which are not returned within the time period shall be confiscated and destroyed.In case any defective medical device set forth in Subparagraph 6 of Article 8 is seized, the municipal or county (city) competent authority shall order the medical device firm that manufactures or imports the device to correct its quality management system within a time period according to the severity of its circumstances.The provisions of Paragraph 1 shall apply mutatis mutandis to medical devices that have been determined to be manufactured or imported without registration and market approval or listing.
中文原文 醫療器材管理法第57條
查獲之不良醫療器材係本國製造者，經查核或檢驗後仍可改製使用時，應由直轄市、縣（市）主管機關派員監督原製造廠商限期改製；其不能改製或屆期未改製者，沒入銷燬之；國外輸入者，應即封存，並由直轄市、縣（市）主管機關令原進口商限期退運出口，屆期未能退貨者，沒入銷燬之。
查獲第八條第六款之不良醫療器材者，按其情節，應令製造、輸入之該醫療器材商限期改正品質管理系統。
經認定為未經查驗登記或登錄而製造、輸入之醫療器材，準用第一項規定。
查獲第八條第六款之不良醫療器材者，按其情節，應令製造、輸入之該醫療器材商限期改正品質管理系統。
經認定為未經查驗登記或登錄而製造、輸入之醫療器材，準用第一項規定。