Global Medical Device Consulting
- Clinical
- Regulatory
- Reimbursement
- Quality
- Distribution
South Korea Medical Device Regulations
South Korea
All documents listed below were published by the Korean Food and Drug Administration (KFDA) and are in PDF format. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in South Korea, you may be interested in our custom regulatory strategy reports for South Korea.
Major Regulations
- Medical Device Act - Act No. 10326, May 27, 2010
- Enforcement Decree of the Medical Devices Act - Presidential Decree No. 23488
- Enforcement regulation of the Medical Device Act - Ministerial Decree No. 85
- 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
- Detailed operational GMP guideline for foreign manufacturers of imported medical devices revision 1 (Korean)
- Updates Regulations for Safety Information Management such as Adverse Event Reporting - KFDA Notification No. 2012-55
- Regulations Regarding Inspection of Used Medical Devices - KFDA Notification No. 2012-8
- Standards for Manufacture, Import and Quality Management of Medical Device - KFDA Notification No. 2011-72
- Regulations for Approval, Notification, evaluation - KFDA Notification No. 2011-82
- 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
Questions? Call or email us.
+1 512 327 9997See list of all offices.
Meet Emergo Group
24 - 28 June - Boston
25 June - Clearwater
9 July - Seoul
30 Jul - 1 Aug - Houston
20-23 November - Düsseldorf
See Which Events We Attend