South Korea Medical Device Regulations

We have assembled the following documents as a service to the medical device community. Documents are in PDF format. If you find a newer version of a document or one that should be included, please marketing [at] emergogroup [dot] com (email us).

Major Regulations

• KGMP quality management system compliance - KFDA Publication No. 2011-149 – DRAFT (Korean)
• Medical device approvals - KFDA Publication No. 2011-151 – DRAFT (Korean)
• Medical Device Act - Act No. 10326
• Enforcement Regulations of the Medical Device Act - Ministerial Decree Number 18
• Enforcement Regulations of the Medical Device Act - Attached Table
• Enforcement Decree of the Medical Device Act - Presidential Decree No. 22075
• Enforcement Decree of the Medical Device Act - Attached Table
• Regulations for Reviewing Technical Document, etc. of Medical Device - Attached Table
• Regulations for Reviewing Technical Document, etc. of Medical Device - KFDA Notification No. 2010-42
• Regulations for Approval, etc. of Medical Device - KFDA Notification No 2010-59
• Regulations for Re-evaluation of Medical Device - Attached Table
• Regulations for Re-evaluation of Medical Device - KFDA Notification No. 2009-142
• Regulations for Re-examination of Medical Device - KFDA Notification No. 2009-202
• Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc. - KFDA Notification No. 2009-164
• Regulations for Prior Review of Medical Device Advertisement - KFDA Notification No. 2009-197

Specific Guidance Documents

• Regulations for Product Classifications of Medical Devices and Class by Product - KFDA Notification No. 2009-41
• Product Classifications of Medical Devices and Class by Products - Attached Table
• Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device - KFDA Notification No. 2009-199
• Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device - Attached Table
• Standards for Manufacture, Import and Quality Management of Medical Device - KFDA Notification No. 2010-30
• Regulations for Designation of Technical Document Review Organization for Medical Device - KFDA Notification No. 2010-69
• Designation of Medical Device Subject to Tracking - KFDA Notification No. 2009-145
• Standards for Management of Clinical Trial for Medical Device - KFDA Notification No. 2010-77
• Guideline on Approving Clinical Investigation Plan for Medical Device - KFDA Notification No. 2009-138
• Standards for Manufacture, Import and Quality Management of Medical Device - Attached Table

Forms and Applications

• Application for Designation of an Orphan Device - KFDA Notification No. 2009-218
• Application for Designation of an Orphan Device - Attached Form
• Regulations for Approval, etc. of Medical Device - Attached Table & Form
• Regulations for Designation of Technical Document Review Organization for Medical Device - Attached Table & Form
• Regulations for Re-examination of Medical Device - Attached Form
• Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc. - Attached Table & Form
• Regulations for Prior Review of Medical Device Advertisement - Attached Form
• Standards for Management of Clinical Trial for Medical Device - Attached Table & Form

Additional Information

• 39 Categories for KGIP