Institutions and Regulatory System
South Korea ensures patient safety is the top priority by operating a strict government certification system, allowing only a limited number of medical institutions to perform Advanced Regenerative Medicine (ARM). Approximately 172 hospitals nationwide (cumulative as of February 2025) are officially registered as ARM facilities certified by the Ministry of Health and Welfare (MOHW), providing a foundation of trust for patients seeking treatment.
Overview of South Korea’s ARM Regulatory System
South Korea’s ARM system is managed under the “Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals” (Advanced Regenerative Bio-Act), which was implemented in August 2020. This law aims to systematically manage and support the safety and efficacy of innovative regenerative medical technologies, such as stem cell therapy and gene therapy.
Strict Designation and Review: Medical institutions must meet all rigorous government standards for facilities, equipment, specialized personnel, Standard Operating Procedures (SOPs) for safety management, and an ethical review system before they can be designated as a ‘Performing Institution’.
Treatment Plan Deliberation: For an institution to perform ARM on a specific patient, the individual treatment plan must undergo separate scientific and ethical review and receive approval from the ‘Advanced Regenerative Medicine and Advanced Biopharmaceuticals Deliberation Committee’.
Patient Safety First: These dual verification procedures prevent unapproved or unverified procedures, providing a reliable treatment environment for patients.pport of Advanced Regenerative Medicine and Advanced Biopharmaceuticals” (Advanced Regenerative Bio-Act), which was implemented in August 2020. This law aims to systematically manage and support the safety and efficacy of innovative regenerative medical technologies, such as stem cell therapy and gene therapy.
Thanks to this robust government oversight, international patients can feel secure in utilizing South Korea’s advanced medical technology. The status of all designated medical institutions is transparently disclosed on the Korea Advanced Regenerative Medicine Portal.
Featured Government-Certified ARM Performing Institutions
These institutions utilize advanced regenerative medicine technologies within their respective fields to provide patient-tailored treatments. Furthermore, most are registered as ‘Medical Tour Agencies for International Patients’ with the MOHW, offering differentiated services such as language support and convenient booking systems.
South Korea’s ARM system maintains a balance between the introduction of innovative technology and strict safety management, establishing the country as a reliable medical hub offering safe and effective treatment solutions to patients worldwide.
When performed by a qualified medical team within a Ministry of Health and Welfare-certified facility, Advanced Regenerative Medicine (ARM) procedures can offer innovative solutions with the highest standards of safety and efficacy. The best way to decide whether ARM treatment is right for you is to meet with a specialist at a government-certified institution for a consultation. You can find these designated medical institutions on the KSH – Find a surgeon Portal.
