The Regulations are enacted pursuant to Paragraph 3, Article 37 of the Medical Devices Act (hereinafter “this Act”).

Terms used in the present Regulations are defined as follows:
1. Subject/Human Subject: An individual who participates in a clinical trial, either as a recipient of the investigational medical device or as a control.
2. Vulnerable Populations: Individuals who are unable to make decisions because of their age or mental or physical conditions; who are susceptible to harmful influences and threats because of their environment, identity, or socioeconomic conditions; or who cannot make decisions according to their free will.
3. Investigator: An individual responsible for the conduct of a clinical trial at a clinical trial institution.
4. Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation and management of a clinical trial.
5. Contract Research Organization: A person or an organization contracted by the sponsor to perform one or more of the sponsor’s clinical investigation-related duties and functions.
6. Deviations: Instance(s) of failure to follow the requirements of the clinical investigation plan.
7. Adverse Event (AE): Any untoward medical occurrence in a subject to whom an investigational medical device is administered and which does not necessarily have a causal relationship with the investigational medical device.
8. Adverse Device Effect (ADE): Adverse event related to the use of an investigational medical device.
9. Subjects may experience the following severe adverse effects:
(1) Death.
(2) Life-threatening condition.
(3) Temporary or permanent disability.
(4) Congenital anomaly of fetus or infant of the subject.
(5) Requiring hospitalization or prolonged hospitalization.
(6) Other complications that may result in permanent injuries.
10. Serious Adverse Device Effect (SADE): Serious adverse effect related to the use of an investigational medical device.

Clinical trials shall be conducted in accordance with the following provisions:
1. Comply with the ethical principles of the Declaration of Helsinki;
2. Conform to scientific principles;
3. Adhere to principles of risk minimization to minimize harm to subjects and ensure that risks and benefits are balanced;
4. Obtain approval from the Institutional Review Board (hereinafter “IRB”);
5. Obtain the consent of subjects; and
6. Protect the autonomy and privacy of subjects.

The sponsor shall draft a clinical investigation plan and submit it to the IRB and the central competent authority for approval before conducting the clinical trial.
The investigator and clinical trial institution shall conduct clinical trial in accordance with clinical investigation plan that has been approved in the preceding paragraph.