Tiếng Việt

20-9 · Y tế, dược phẩm và thiết bị y tế

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.

HWANG YUNSANG ADMINISTRATIVE OFFICESONGDO · 37.3892° N / 126.6439° E
#Designation of Advanced Regenerative Medicine Institutions (including clinics)#Kiểm tra chính thức#20-9
01

Quy trình

Quy trình

  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

Nơi và cách nộp

Nơi và cách nộp

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

Hãy xác nhận cơ quan tiếp nhận, thẩm quyền và hình thức trực tuyến mới nhất trên trang chính thức.

Kiểm tra chính thức
Cơ quan xử lý thực tếMinistry of Health and Welfare
Cơ quan phụ trách chế độ và chính sáchMinistry of Health and Welfare
Đường dẫn trực tuyếnKiểm tra chính thức
03

Thời hạn và lưu ý thủ tục

Thời hạn và lưu ý thủ tục

Xác nhận thời hạn và bước tiếp theo theo thông báo, ngày nộp và yêu cầu bổ sung hồ sơ.Kiểm tra chính thức
04

Hồ sơ cơ bản

Hồ sơ cơ bản

Hồ sơ cơ bản0 / 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.

Hướng dẫn phạm vi công việc

Hướng dẫn phạm vi công việc

Văn phòng đại lý hành chính Hwang Yunsang soạn thảo, dịch hồ sơ nộp cho cơ quan hành chính, nộp thay và hướng dẫn thủ tục cấp phép·đăng ký·khai báo. Các thủ tục yêu cầu người nộp phải xuất trình trực tiếp, tự nộp hoặc chữ ký điện tử có thể bị hạn chế việc ủy quyền.