Clinical trial institutions or trial sponsors shall file an application with the central competent authority and obtain its approval before initiating any clinical trial. However, this shall not apply to those that do not involve significant risks as announced by the central competent authority.
Clinical trial institutions implementing clinical trials of the preceding paragraph shall exercise the necessary duty of medical care, and shall obtain consent from human subjects except in the case of emergencies.
Regulations governing the scope of management, operational practices, application procedures, review guidelines, avoidance of conflicts of interest, information disclosure, supervision and administration, inspection, particulars of the content of informed consent referred to in the preceding two paragraphs, and other matters to be complied with in regard to medical device clinical trials shall be established by the central competent authority.

Clinical trial institutions and trial sponsors shall report to the central competent authority when the human subject of a medical device clinical trial experiences any of the following occurrences during implementation of the clinical trial:
1. Death.
2. Life-threatening condition.
3. Temporary or permanent disability.
4. Congenital anomaly of fetus or infant of the human subject.
5. Requiring hospitalization or prolonged hospitalization.
6. Other complications that may result in permanent injuries.
Clinical trial institutions shall report to the central competent authority when the human subject experiences any of the occurrences in the preceding paragraph after termination of the clinical trial and when the occurrence is related to the clinical trial.
The reporting set forth in the preceding two paragraphs shall be made within seven days after becoming aware of the actual happening of the occurrence, and detailed investigation information shall be submitted to the central competent authority within fifteen days for recordation.

In the event that the central competent authority deems there is concern that a medical device clinical trial may cause harm to the health of human body, it may order trial institutions to suspend or terminate the trial or to adopt other necessary measures.