Medical Devices Act Article 28

Medical device firms that have completed the listing of medical devices shall file an annual declaration with the central competent authority each year. For those who fail to file a declaration within the time period, the original listing shall become invalid. This shall also apply to the medical devices subject to direct listing as stipulated in the provisions of Paragraph 4 of Article 25.
中文原文 醫療器材管理法第28條
醫療器材商完成醫療器材登錄者,每年應向中央主管機關辦理年度申報;屆期未申報者,原登錄失其效力。
依第二十五條第四項規定逕予登錄之醫療器材,亦同。

English translation for reference only; the Chinese text prevails. Not legal advice.