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Korea Medical Device Regulations
Korean Regulations and Public Notifications
 1. Medical Device Act- 1.1. Annex to the Enforcement Decree of the Medical Device Act.pdf
- 2. Enforcement Decree of the Medical Device Act.pdf
- 3. Enforcement Regulations of the Medical Device Act.pdf
- 3.1. Annex to the Enforcement Regulations of the Medical Device Act.pdf
- 4. Regulations for Product Classification of Medical Device and Class by Product.pdf
- 4.1. Annex to the Regulations for Product Classification of Medical Device and Class by Product.pdf
- 5. Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device.pdf
- 5.1. Annex to the Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Deviceof Medical Device.pdf
- 6. Regulations for Designation of Orphan Device.pdf
- 6.1. Annex to the Regulations for Designation of Orphan Device.pdf
- 7. Regulations for Approval, etc. of Medical Device.pdf
- 7.1. Annex to the Regulations for Approval, etc. of Medical Device.pdf
- 8. Regulations for Reviewing Technical Document, etc. of Medical Device.pdf
- 8.1. Annex to the Regulations for Reviewing Technical Document, etc. of Medical Device.pdf
- 9. Regulations for Designation of Technical Document Review Organization for Medical Device.pdf
- 9.1. Annex to the Regulations for Designation of Technical Document Review Organization for Medical Device.pdf
- 10. Standards for Manufacture, Import and Quality Management of Medical Device.pdf
- 10.1. Annex to the Standards for Manufacture, Import and Quality Management of Medical Device.pdf
- 11. Guideline on Approving Clinical Investigation Plan for Medical Device.pdf
- 12. Standards for Management of Clinical Trial for Medical Device.pdf
- 12.1. Annex to the Standards for Management of Clinical Trial for Medical Device.pdf
- 13. Regulations for Prior Review of Medical Device Advertisement.pdf
- 13.1. Annex to the Regulations for Prior Review of Medical Device Advertisement .pdf
- 14. Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.pdf
- 14.1. Annex to the Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.pdf
- 15. Regulations for Re-examination of Medical Device.pdf
- 15.1. Annex to the Regulations for Re-examination of Medical Device.pdf
- 16. Regulations for Re-evaluation of Medical Device.pdf
- 16.1. Annex to the Regulations for Re-evaluation of Medical Device.pdf
- 17. Designation of Medical Device Subject to Tracking.pdf
- Terms (Korean to English).pdf
- Terms (English to Korean).pdf
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