Regulations Governing Monitoring Inspection Article 15
Under any of the following circumstances, the procedure of batch-by-batch examination may apply to commodities subject to monitoring inspection:1. Where international/domestic safety information or scientific evidence shows that the commodity may substantially endanger human health;2. Where the inspection results during the past do not comply with applicable requirements;3. Where the monitoring results do not comply with applicable requirements;4. Where the inspection results of commodities placed on the market do not comply with applicable requirements; and5. Where there is any other non-compliance.For commodities that are mentioned in subparagraphs 1 to 2 of the preceding paragraph and apply batch-by-batch examination, the procedure of random-selected batch inspection shall apply if the applicant has made applications for commodities of the same origin, same manufacturing site or brand, or same type or specification and these commodities comply with the requirements for a certain number of consecutive batches. If non-conformities are found during the procedure of random-selected batch inspection, batch-by-batch examination will be applied thereafter to commodities of that applicant.For commodities that are mentioned in subparagraph 3 of the preceding paragraph and apply batch-by-batch examination, the procedure of specific monitoring program shall apply if the applicant has made applications for commodities of the same origin, same manufacturing site or brand, or same type or specification and these commodities comply with the requirements for a certain number of consecutive batches.For commodities that are mentioned in subparagraph 4 to 5 of the preceding paragraph and apply batch-by-batch examination, the originally announced procedure shall apply if the applicant has made applications for commodities of the same origin, same manufacturing site or brand, or same type or specification and these commodities comply with the requirements for a certain number of consecutive batches.
中文原文 商品監視查驗辦法第15條
應施監視查驗商品有下列情事之一者，得採逐批查驗：
一、國內外商品安全相關資訊或具有科學證據對人體有顯著危害。
二、依歷年查驗結果未符合規定。
三、依監視結果未符合規定。
四、國內市場商品，經購、取樣檢驗結果未符合規定。
五、其他未符合檢驗規定。
前項第一款及第二款採逐批查驗之商品，報驗義務人報驗同產地、同廠場或廠牌、同型式或規格經連續一定批數符合規定者，改採抽批查驗。
但抽批查驗未符合規定者，改採逐批查驗。
第一項第三款採逐批查驗之商品，報驗同產地、同廠場或廠牌、同型式或規格經連續一定批數符合規定者，改採監視。
第一項第四款及第五款採逐批查驗之商品，報驗義務人報驗同產地、同廠場或廠牌、同型式或規格經連續一定批數符合規定者，改採原查驗方式。
一、國內外商品安全相關資訊或具有科學證據對人體有顯著危害。
二、依歷年查驗結果未符合規定。
三、依監視結果未符合規定。
四、國內市場商品，經購、取樣檢驗結果未符合規定。
五、其他未符合檢驗規定。
前項第一款及第二款採逐批查驗之商品，報驗義務人報驗同產地、同廠場或廠牌、同型式或規格經連續一定批數符合規定者，改採抽批查驗。
但抽批查驗未符合規定者，改採逐批查驗。
第一項第三款採逐批查驗之商品，報驗同產地、同廠場或廠牌、同型式或規格經連續一定批數符合規定者，改採監視。
第一項第四款及第五款採逐批查驗之商品，報驗義務人報驗同產地、同廠場或廠牌、同型式或規格經連續一定批數符合規定者，改採原查驗方式。