Medical Devices Act Article 49
Upon the finding that a medical device is likely to cause harm to the health of human body, the holders of the medical device license or those who have completed the listing shall immediately and proactively report to the central competent authority and undertake corrective and preventive measures.The corrective and preventive measures set forth in the preceding paragraph include preparation of advisory contents, replacement of parts and accessories, product testing, suspension of use, product recall, or other necessary measures, and shall be disclosed in a reasonable manner for awareness of medical institutions, medical device firms, and users.
中文原文 醫療器材管理法第49條
醫療器材許可證所有人或登錄者發現醫療器材有危害人體健康之虞時，應即主動通報中央主管機關，並採取矯正預防措施。
前項矯正預防措施，應包括訂定警訊內容、更換零配件、產品檢測、暫停使用、產品回收或其他必要措施，並以合理方式揭露之，供醫事機構、醫療器材商及使用者知悉。
前項矯正預防措施，應包括訂定警訊內容、更換零配件、產品檢測、暫停使用、產品回收或其他必要措施，並以合理方式揭露之，供醫事機構、醫療器材商及使用者知悉。