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20-9 · Healthcare, medicines & medical devices

Designation of Advanced Regenerative Medicine Institutions (including clinics)

Under Article 10 of the Advanced Regenerative Medicine and Advanced Biological Products Safety and Support Act, a medical institution that wants to conduct advanced regenerative medicine clinical research or treatment must be designated by the Minister of Health and Welfare as an advanced regenerative medicine institution; any medical institution except a midwifery clinic, including a clinic-level institution, may apply. To be designated, the institution must have the human cell storage room, records room, testing room, treatment room and air-conditioning system listed in Annex 1 of the Rules on Advanced Regenerative Medicine Safety and Support, and must appoint at least one each of a principal investigator, practitioner, human cell manager and information manager, each of whom must complete at least 8 hours of basic training before starting work. The application, with proof of medical institution establishment, documents proving the standards are met, standard operating procedures, and an IRB registration certificate or IRB entrustment agreement, has a processing period of 20 days, and the Minister may conduct an on-site inspection to check compliance. Designation is only the eligibility to perform: each clinical research plan and each treatment plan must still be reviewed by the Deliberation Committee before it can be carried out.

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#Designation of Advanced Regenerative Medicine Institutions (including clinics)#Official check#20-9
🌐 Advanced Regenerative Medicine Institution Designation: Documents and Standards
01

Procedure

Procedure

  1. 01

    Confirm the type of practice and staffing: Decide first whether you will conduct clinical research or treatment. Clinical research requires at least one physician among the principal investigator or practitioners, and treatment requires at least one physician, dentist or Korean medicine doctor as principal investigator, so check whether your medical staff can fill all four roles.

  2. 02

    Check facilities and equipment: Compare item by item against Annex 1 the human cell storage room with refrigeration/freezing equipment and automatic temperature recorder, the records room with security equipment, the testing room, the treatment room (operating room, recovery room, sterilization facility) and the air-conditioning system, and organize gaps, floor plans and equipment lists.

  3. 03

    Appoint staff and confirm basic training: Appoint at least one person for each of the four roles and confirm with certificates that each completed the basic training of at least 8 hours announced by the Minister before starting work. If the institution itself collects, cultures or processes human cells, appoint a separate processing staff member.

  4. 04

    Prepare SOPs and IRB documents: Tailor the standard operating procedures needed for advanced regenerative medicine, such as human cell storage and record management, to the institution. Prepare the IRB registration certificate if you registered your own IRB, or the entrustment agreement if you entrust another institution's IRB.

  5. 05

    Submit the application and respond to inspection: Submit the application (Form No. 1) with attachments to the Minister of Health and Welfare; the processing period is 20 days, and you supplement materials in response to inspections and correction requests. After designation, if the institution no longer meets the standards, it must notify the Minister within 10 days of becoming aware of it.

02

Filing route

Filing route

Ministry of Health and Welfare (application and attachments submitted in paper or electronic form)

Confirm the current filing office, jurisdiction, and online availability on the official website.

Official check
Actual processing agencyMinistry of Health and Welfare
Statutory and policy authorityMinistry of Health and Welfare
Online routeOfficial check
03

Deadlines & processing notes

Deadlines & processing notes

Check deadlines and next steps against the notice, filing date, and any request for additional documents.Official check
04

Basic documents

Basic documents

Basic documents0 / 8

Without basic training certificates for all four roles you cannot prove the staffing standards and the application is delayed, so schedule the training before preparing the documents.

Scope of services

Scope of services

Hwang Yunsang Administrative Agent Office prepares and translates documents for administrative agencies, submits them on your behalf, and guides you through permit, application, and notification procedures. Services that require the principal’s personal appearance, principal’s application, or electronic signature may be limited in delegation.