Regulations on Management of Medicament Samples and Gifts Article 11

For applications made in accordance with the stipulations of Article 2, Subparagraph 2 for an investigational medical device that has not yet 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 provisional medical center level or above that is conducting the trial.II. Structure, specifications, performance, purpose, drawings and other technical data for the trial medical device.III. Trial data on safety and efficacy of the investigational trial medical device.IV. A human trial protocol that is compliant with the stipulations of Article 50 of the Enforcement Rules of the Medical Care Act.V. The Informed Consent Form.