The rapid expansion of assisted reproductive technologies (ART), the growing demand for infertility treatment, and advances in life sciences have intensified ethical debates over embryo production, underscoring the need for stricter regulation of embryo-producing medical institutions.
This study identified shortcomings in the current designation criteria (personnel, facilities, and equipment) and proposed more practical standards, along with stronger post-management measures such as re-designation, on-site evaluations, and professional certification for embryologists. In the long term, it recommends establishing a comprehensive legal framework, either through a unified ART law or by positioning the Bioethics and Safety Act as a fundamental law with ART-specific regulations.