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20-2 · Healthcare, medicines & medical devices

Tissue Bank Establishment Permit and Renewal (Human Tissue Import and Processing)

To procure, store, process, import, keep or distribute human tissue such as bone, cartilage, skin, amniotic membrane or heart valves for transplantation, a tissue bank establishment permit must be obtained from the regional office of the Ministry of Food and Drug Safety with jurisdiction over the location under Article 13 of the Act on Safety and Management of Human Tissue, after meeting the facility, equipment, personnel and quality management system standards in Appended Table 1 of the Enforcement Decree. Those eligible for the permit are medical institutions, non-profit corporations established mainly for tissue-related business, tissue processors and tissue importers; tissue processors and tissue importers may not carry out tissue donation or procurement. Under Article 14 of the same Act the permit is valid for 3 years from the date granted; to keep operating, a renewal must be applied for at least 60 days before expiry, and renewal may be refused if the bank has no record of procuring, storing, processing, importing, keeping or distributing tissue in the previous 3 years. A change permit is required to change the name, representative, location, head of the tissue bank, medical director, type, scope of work or type of tissue handled.

HWANG YUNSANG ADMINISTRATIVE OFFICESONGDO · 37.3892° N / 126.6439° E
#Tissue Bank Establishment Permit and Renewal (Human Tissue Import and Processing)#Official check#20-2
🌐 Tissue Bank Establishment Permit and Renewal Documents
01

Procedure

Procedure

  1. 01

    Decide the type and scope of work: choose the application type among medical institution, non-profit corporation, tissue processor and tissue importer, and select the work to be performed (procurement, storage, processing, import, keeping, distribution) and the types of tissue handled. Tissue processors and importers cannot carry out donation or procurement.

  2. 02

    Check facilities and equipment against the standards: tissue processors need a tissue processing room, diagnostic laboratory, tissue storage room and records room; tissue importers need a diagnostic laboratory, tissue storage room and records room, each partitioned to prevent cross-contamination. If microbiological testing is outsourced to an equipped medical institution, the related test equipment may be omitted.

  3. 03

    Confirm staffing: appoint at least one each of a head of the tissue bank, a medical director who is a physician or dentist, a tissue handler, a quality manager and an administrative officer. The tissue handler may also serve as the administrative officer, and in medical institution or non-profit tissue banks the medical director may also serve as head.

  4. 04

    Prepare the quality management system and standard operating procedures: organize SOPs suited to the bank type covering operation and staffing, facility and equipment management, donation and transplant suitability, receipt, release and distribution, labeling, nonconforming tissue, recall and disposal, adverse events and traceability, corrective action, training and self-inspection, and document and record control. Importers include import management.

  5. 05

    File the establishment permit application and respond to supplementation: submit the tissue bank establishment permit application with the facility, equipment and staffing status, a copy of the medical director's license, quality management system documents and a business operation plan to the regional office with jurisdiction, respond to supplementation requests and on-site checks, and receive the tissue bank establishment permit certificate.

  6. 06

    Manage import approval, changes and renewal: to import tissue, obtain import approval from the Minister of Food and Drug Safety for each tissue and register the foreign manufacturer. File a change permit application when key items change, and at least 60 days before expiry file the renewal application with the original permit certificate and records of tissue processing or imports for the previous 3 years.

02

Filing route

Filing route

Regional office of the Ministry of Food and Drug Safety with jurisdiction over the location (electronic filing available)

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

Official check
Actual processing agencyCompetent Korean authority or official service
Statutory and policy authorityMinistry of Food and Drug Safety
Online routeCompetent Korean authority or official service
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

The renewal must be filed at least 60 days before expiry, and renewal may be refused without activity in the previous 3 years, so keep processing and import records organized every year and put the filing deadline on your schedule.

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.