Regulations on Management of Medicament Samples and Gifts Article 15

For applications for medical device samples for specific exhibitions or demonstrations in accordance with the stipulations of Article 2, Subparagraph 5, the following materials shall be attached:I. Medical device package insert, instructions, catalog and their Chinese translations.II. The letter of consent for exhibition issued by the medical association, academic institution or medical institution.III. An affidavit stating that the approved medical device sample will absolutely not be sold, transferred, used for other purposes or used in clinical treatment, and that the sample will be returned on time in accordance with the stipulations of Article 17.For medical devices having radiation, a written consent from the Atomic Energy Council of the Executive Yuan shall be attached.