Regulations on Management of Medicament Samples and Gifts Article 16

For a medical device sample approved as meeting the stipulations of Article 2, Subparagraph 5, the exhibition or demonstration period may not exceed six months.The applicant shall return the following medical devices to the manufacturer within one month after the exhibition, demonstration period, treatment or clinical trial ends, and the applicant shall submit the customs return export certificate to the central health competent authority for processing:I. Medical device samples approved as meeting the stipulations of Article 2, Subparagraph 5.II. Medical device instrument samples approved as meeting the stipulations of Article 2, Subparagraph 2 or 3.
中文原文 藥物樣品贈品管理辦法第16條
符合第二條第五款規定並經核准之醫療器材樣品,其展覽或示範期間不得超過六個月。
申請者應將下列醫療器材於展覽、示範期間結束或治療、臨床試驗計畫完成後一個月內退運原廠,並將海關退運出口證明文件送中央衛生主管機關核辦:
一、符合第二條第五款規定並經核准之醫療器材樣品。
二、符合第二條第二或第三款規定並經核准之醫療器材儀器樣品。

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