Medical Devices Act Article 41
In the event that a medical device firm wishes to publish or broadcast a medical device advertisement, the license holder or the person who has completed the listing shall, before publishing or broadcasting, submit all texts, pictures, or speeches constituting the advertisement to the municipal competent authority if the medical device firm is located in a municipality, or to the central competent authority if it is located in a county (city), for approval.During the approved period of publishing or broadcasting, no modification or alteration of the approved content of a medical device advertisement shall be allowed.If the original approving authority finds that the content of an approved medical device advertisement or the way it is published or broadcast violates the provisions of the preceding paragraph or may cause harm to the health of human body, it shall order the medical device firm to immediately stop publishing or broadcasting the said advertisement or to make corrections within a time period. For those who fail to make corrections within the time period, their approval shall be cancelled.The authority imposing the disciplinary action set forth in the preceding paragraph shall notify with a copy to the mass media enterprises publishing or broadcasting the advertisement of the action.
中文原文 醫療器材管理法第41條
醫療器材商刊播醫療器材廣告時,應由許可證所有人或登錄者於刊播前,檢具廣告所有文字、圖畫或言詞,依醫療器材商登記所在地,在直轄市者向直轄市主管機關,在縣(市)者向中央主管機關,申請核准刊播;經核准後,應向傳播業者送驗核准文件,始得刊播。
醫療器材廣告於核准刊播期間,不得變更原核准事項而為刊播。
原核准機關發現已核准之醫療器材廣告內容或刊播方式違反前項規定,或對民眾人體健康有危害之虞時,應令醫療器材商立即停止刊播或限期改善;屆期未改善者,廢止其核准。
為前項處分之機關應副知刊播之傳播業者。
醫療器材廣告於核准刊播期間,不得變更原核准事項而為刊播。
原核准機關發現已核准之醫療器材廣告內容或刊播方式違反前項規定,或對民眾人體健康有危害之虞時,應令醫療器材商立即停止刊播或限期改善;屆期未改善者,廢止其核准。
為前項處分之機關應副知刊播之傳播業者。