Regulation for Registration of Medical Devices Article 6
When an application fails to comply with regulations and must be corrected, the applicant shall make correction by the deadline designated by the notification of the central health competent authority. The correction deadline shall be two months after the issue of the notification.If the applicant cannot make correction by the deadline, the applicant is entitled to apply for an extension of the designated deadline for one month before the original deadline expires; such extension shall be granted only once.If the applicant fails to make correction before the deadline, or fails to make correction before the expiration of the one-month extension period, the central health competent authority may perform review on the basis of existing information and accept or reject the application.
中文原文 醫療器材查驗登記審查準則第6條
申請案件如有不符規定而得補正之情形時，申請人應依中央衛生主管機關通知之期限內補正。
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，向中央衛生主管機關申請延期一個月，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審查核駁。
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，向中央衛生主管機關申請延期一個月，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審查核駁。