1. Medical Device Manufacturing (Import) Business Licence (의료기기 제조(수입)업 허가증)
2. Medical Device Manufacturing (Import) Licence (의료기기 제조(수입) 허가증)
3. Certificates of Medical Device Manufacturing (import) (의료기기 제조(수입) 인증서)
4. Certificate of Manufacturer(Importer) (의료기기영문증명)
5. Certificate of Free Sales (의료기기품목영문증명)
6. Designation of Institution for Medical Device Clinical Investigation (의료기기 임상시험기관 지정서)
7. Review Result Notification of Medical Device Technical Documents, etc. (의료기기 기술문서 등의 심사결과 통지서)
8. Medical Device Protocol Approval Letter (의료기기 임상시험계획 승인서)
9. Conformation form of Investigational Medical Devices (시험용 의료기기 확인서)
10. Designation of In Vitro Diagnostic Medical Device Clinical Performance Study Institutions (체외진단의료기기 임상적 성능시험기관 지정서)
11. In Vitro Diagnostic Medical Device Clinical Performance Study Plan Approval Letter (체외진단의료기기 임상적 성능시험 계획 승인서)
12. Certification of In Vitro Diagnostic Test in Clinical Laboratories (임상검사실의 체외진단검사 인증서)
13. Designation of Institutions Conducting Non-Clinical Study (의료기기 비임상시험실시기관 지정서)
14. Certificates of GMP Suitable (GMP 적합인정서)