Regulations on Management of Medicament Samples and Gifts Article 12

For applications made in accordance with the stipulations of Article 2, Subparagraph 2 for a medical device that has been approved for sale by the country of origin, where the application is made for purposes of clinical trial, the following materials shall be submitted:I. A written consent from the Institutional Review Board of the teaching hospital at regional level or above that is conducting the trial.II. The medical device's Certificate for Foreign Government issued by the country of origin.III. A human trial protocol that is compliant with the stipulations of Article 50 of the Enforcement Rules of the Medical Care Act.IV. The Informed Consent Form.