Regulations of Medicament Manufacturer Inspection Article 7-1
If the documents for the application of medical device GMP compliance are insufficient, the applicant should submit the required supplementary documents in two months. If the supplementary documents can not be prepared accordingly and timely, the applicant can apply for an extension of one additional month in time. The extension is granted for once only. If the supplementary documents can not be submit in time (with or without extension), the central competent health authority will make decision by the existing documents.
中文原文 藥物製造業者檢查辦法第7-1條
申請檢查符合醫療器材優良製造規範者，所附資料如有不符規定而得補正時，申請人應於通知期限內補正之。
補正期限為二個月。
申請人如未能於期限內補正者，得於補正期滿前，申請延期一個月，且延期以一次為限。
申請人如未於期限內補正或延期一個月後仍逾期未補正者，中央衛生主管機關得依現有資料逕為檢查判定。
補正期限為二個月。
申請人如未能於期限內補正者，得於補正期滿前，申請延期一個月，且延期以一次為限。
申請人如未於期限內補正或延期一個月後仍逾期未補正者，中央衛生主管機關得依現有資料逕為檢查判定。