According to: Article 37, Paragraph 1, Subparagraph of the Medical Device Management Act.
Announcement:
1. Clinical trial institutions or trial sponsors initiating a medical device clinical trial must apply for approval from the central competent authority before proceeding. Medical device clinical trials that meet any of the following conditions are considered low‑risk medical device clinical trials and are exempt from applying for central authority approval:
(a) The medical device used in the trial has obtained a license or registration in accordance with the Medical Device Management Act, and its intended use, mode of use, and technical characteristics in the clinical trial do not exceed the approved scope; for registered devices, they do not exceed the identification scope.
(b) The medical device used in the trial directly uses legally obtained subject specimens or data as the object of a diagnostic test, and the results obtained during the trial phase are not used as the basis for clinical diagnosis.
(c) For trial medical devices without free radiation, their use is placed on the subject’s body surface or does not require contact with the subject’s body surface, conducting data‑collection trials, or using the collected data for diagnostic tests, and the results obtained during the trial phase are not used as the basis for clinical diagnosis.
2. The data referred to in the preceding point includes the subject’s test data, medical images, physiological parameters, or medical records.
