Medical Devices Act Article 73
In the event that approval is not given to the application for medical device clinical trial implementation, medical device registration and market approval, or change or extension of a license filed in accordance with this Act, the disagreeing applicant may, within four months upon receipt of the notice of disciplinary action, clearly state the reasons and apply for re-examination. However, only one application for re-examination is allowed.The central competent authority shall alter or cancel the original disciplinary action if it deems that the application for re-examination set forth in the preceding paragraph is justifiable.If the person applying for re-examination does not agree with the decision made regarding the re-examination, he/she may file an administrative appeal and initiate an administrative proceeding in accordance with applicable laws.
中文原文 醫療器材管理法第73條
依本法申請執行醫療器材臨床試驗、醫療器材查驗登記、許可證變更或展延，未獲核准，申請人不服者，應自處分書送達之日起四個月內，敘明理由提出申復。
但以一次為限。
中央主管機關對前項申復認有理由者，應變更或撤銷原處分。
申復人不服申復決定者，得依法提起訴願及行政訴訟。
但以一次為限。
中央主管機關對前項申復認有理由者，應變更或撤銷原處分。
申復人不服申復決定者，得依法提起訴願及行政訴訟。