Medical Devices Act Article 48
Medical device firms or medical institutions shall report any serious adverse events caused by medical devices to the central competent authority.Regulations governing the conditions, reporting methods, time period, contents, and other matters to be complied with in regard to the serious adverse events referred to in the preceding paragraph shall be established by the central competent authority.
中文原文 醫療器材管理法第48條
醫療器材商或醫事機構發現醫療器材嚴重不良事件，應通報中央主管機關。
前項嚴重不良事件之情形、通報方式、期限、內容及其他應遵行事項之辦法，由中央主管機關定之。
前項嚴重不良事件之情形、通報方式、期限、內容及其他應遵行事項之辦法，由中央主管機關定之。