Non-medical care institutions are not allowed to implement regenerative medicine.

A medical care institution shall apply for approval from the central competent authority before implementing a regenerative technique or using a regenerative product designated by the central competent authority. After obtaining approval, it shall register with the competent authority of the direct-jurisdiction municipality or county (city) before proceeding.
The central competent authority may entrust its subordinate agencies or other agencies (institutions), juridical persons, or organizations to handle the approval matters referred to in the preceding paragraph.
The methods for designating regenerative products under Paragraph 1, the conditions and procedures for applying for approval, the validity period and renewal of approval, cancellation, changes in approved matters, fee review and collection, refunds, and other matters to be observed shall be determined by the central competent authority.

A physician who implements regenerative medicine shall be a specialist in the relevant field of the disease. The central competent authority shall announce the qualifications for such physicians.

Medical care institutions perform regenerative techniques that require to conduct cell culture, processing, and preservation (collectively referred to as “cell operation”) can do themselves or commission regenerative medicine biotechnology and pharmaceutical companies or medical care institutions (collectively referred to as “commissioned institutions”) to do so when necessary.
The medical care or commissioned institutions performing cell operation under the preceding paragraph shall be exempt from obtaining a drug manufacturing license under the Pharmaceutical Affairs Act. Before performing cell operation, said institutions shall be inspected and approved by the central competent authority.
The central competent authority may entrust its subordinate agencies or other agencies (institutions), juridical persons, or organizations to handle the inspection, approval, and other related management matters referred to in the preceding paragraph.
The methods, facilities, equipment, control measures, distribution, operator qualifications and required related training, inspection, application conditions and procedures for approval, validity period and renewal, cancellation, changes in approval matters, and other regulations to be observed for cell operation by medical care or commissioned institutions referred to in Paragraph 2 shall be determined by the central competent authority.

Before implementing regenerative medicine, a medical care institution shall explain to the patient or his/ her legal representative, spouse, relatives, or related persons the possible effects and adverse reactions, costs, relief measures, and other necessary matters.
Before implementing regenerative medicine, a medical care institution shall obtain the consent of the patient or his/ her legal representative, spouse, relatives, or related persons and sign a consent form before proceeding.
The central competent authority shall determine the content of the consent form under the preceding paragraph.

A medical care institution that uses regenerative products designated by the central competent authority or implements regenerative technique shall keep records for at least fifteen years and register the items designated by the central competent authority in the information system established by the central competent authority. However, records of minors shall be kept for at least fifteen years after they reach adulthood.
The content of the records under the preceding paragraph shall include the date, place, and procedure of use or implementation, the regenerative products used, the regenerative technique implemented, serious adverse events, and other matters designated by the central competent authority.