[Title Page]
Contents
Ⅰ. Overview of Approval, Certification, and Notification of Medical Devices 12
Ⅰ-1. Approvals, Certifications, and Notifications by Year 12
Ⅰ-2. Approvals, Certifications, and Notifications by Class 19
Ⅰ-3. Approvals, Certifications, and Notifications by Section 24
Ⅰ-4. Approvals, Certifications, and Notifications by Division 30
Surgical Supplies(B07000) 44
Ophthalmic Lens(A77000) 47
Instruments for Ligature and Suture(A38000) 49
Measuring and Introducing Instrument(A64000) 51
IVD Reagent for Infectious Disease, Immunological Method(K05000) 54
Tube and Catheter for Medical Use(A57000) 56
Puncturing, Abrasion, and Perforating Instrument for Medical Use(A55000) 59
Medical Devices for Orthopedics and Restoration(A67000) 62
Speculums for Medical Use(A31000) 64
Splints(B05000) 68
Ⅰ-5. Frequently Approved, Certified, and Notified Items 69
Ⅱ. Approvals, Certifications, and Notifications by Type 76
Ⅱ-1. Approval of Medical Devices Subject to Re-evaluation 76
Ⅱ-2. Item Category Certifications and Notifications 86
Ⅱ-3. Certification of Recognized Substantial Equivalent Products 92
Ⅱ-4. Approval of Medical Devices Subject to Clinical Trial Data Submission Requirements 96
Ⅱ-5. Conditional Approvals and Certifications 105
Ⅱ-6. Approval of Medical Devices Subject to Tracking Management 107
Ⅲ. Approvals, Certifications, and Notifications by Composition 113
Ⅲ-1. Approval of Medical Devices Combined/Compounded with Drugs 113
Ⅲ-2. Approvals, Certifications, and Notifications of Combination Medical Devices 115
Ⅲ-3. Approvals, Certifications, and Notifications of Medical Device Packages 118
Ⅲ-4. Approval, Certification, and Notification of Combined/Compounded Items of Medical Devices/IVD Medical Devices 120
Ⅳ. Approvals, Certifications, and Notifications of Advanced Medical Devices 125
Ⅳ-1. (A) Instruments 125
Approvals, Certifications, and Notifications of 3D-Printed Medical Devices 125
Approvals, Certifications, and Notifications of AI-Based Medical Devices 131
Approval of Robot-Based Surgical and Rehabilitation Medical Devices 146
Ⅳ-2. (B) Medical Supplies 153
Approvals, Certifications, and Notifications of 3D-Printed Medical Devices 153
Ⅳ-3. (C) Dental Materials 164
Approvals, Certifications, and Notifications of 3D-Printed Medical Devices 164
Ⅴ. Approval of COVID-19 Diagnostic Reagents 169
Ⅴ-1. Formal Approval of COVID-19 Diagnostic Reagents 169
Ⅴ-2. Approval of COVID-19 Diagnostic Reagents for Export 172
Attachment : Medical Device Evaluation Process 176
1.1. Medical Device Approval/Certification/Notification Process 176
1.2. Certification Process for Recognized Substantial Equivalent Products 177
Copyright 180
[Table 1] Overview of Approvals, Certifications, and Notifications by Year(2016-2020) 13
[Table 2] Approval, Certification, and Notification of Manufactured/Imported Devices by Year(2016-2020) 15
[Table 3] Revised Approval and Certification of Manufactured/Imported Devices by Year(2016-2020) 16
[Table 4] Revised Approvals and Certifications by Evaluation Type and Year(2016-2020) 18
[Table 5] Approvals, Certifications, and Notifications by Class and Year(2016-2020) 19
[Table 6] Approvals, Certifications, and Notifications of Manufactured/Imported Devices by Class and Year(2016-2020) 21
[Table 7] Approval, Certification, and Notification of Manufactured/Imported Items in 2020 23
[Table 8] Items by Section and Year(2016-2020) 24
[Table 9] Approval, Certification, and Notification of Manufactured/Imported Devices in 2020 by Section 26
[Table 10] In Vitro Diagnostic Devices by Section in 2020 28
[Table 11] Approval, Certification, and Notification of Manufactured/Imported In Vitro Diagnostic Devices by Section in 2020 29
[Table 12] (Top 10) Divisions Including High-Frequency Items in 2020 30
[Table 13] Approved, Certified, and Notified Items in 2020 by Division((A) Medical Instruments) 31
[Table 14] Approved, Certified, and Notified Items in 2020 by Division((B) Medical Supplies) 34
[Table 15] Approved, Certified, and Notified Items in 2020 by Division((C) Dental Materials) 35
[Table 16] Approved, Certified, and Notified Items in 2020 by Division((E) Software for Cardiovascular) 36
[Table 17] Approved, Certified, and Notified Items in 2020 by Division((I) Devices for Sample Preparation) 37
[Table 18] Approved, Certified, and Notified Items in 2020 by Division((J) Devices for Clinical Chemistry) 38
[Table 19] Approved, Certified, and Notified Items in 2020 by Division((K) Devices for Clinical Immunity) 39
[Table 20] Approved, Certified, and Notified Items in 2020 by Division((M) Devices for Clinical Microbiology) 40
[Table 21] Approved, Certified, and Notified Items in 2020 by Division((N) Devices for Molecular Diagnostics) 41
[Table 22] Approved, Certified, and Notified Items in 2020 by Division((O) Pathology Devices for Others) 42
[Table 23] Approved, Certified, and Notified Items in 2020 by Division((P) IVD Software) 43
[Table 24] "Surgical Supplies(Division)" Items in 2020 44
[Table 25] "Ophthalmic Lens(Division)" Items in 2020 47
[Table 26] "Instruments for Ligature and Suture(Division)" Items in 2020 49
[Table 27] "Measuring and Introducing Instrument(Division)" Items in 2020 51
[Table 28] "IVD Reagent for Infectious Disease, Immunological Method(Division)" Items in 2020 54
[Table 29] "Tube and Catheter for Medical Use(Division)" Items in 2020 56
[Table 30] "Puncturing, Abrasion, and Perforating Instrument for Medical Use(Division)" Items in 2020 60
[Table 31] "Medical Devices for Orthopedics and Restoration(Division)" Items in 2020 62
[Table 32] "Speculums for Medical Use(Division)" Items in 2020 64
[Table 33] "Splints(Division)" Items in 2020 68
[Table 34] Frequently Approved Manufactured/Imported Items in 2020 69
[Table 35] Frequently Certified Manufactured/Imported Items in 2020 71
[Table 36] Frequently Notified Manufactured/Imported Items in 2020 73
[Table 37] Medical Devices Subject to Re-evaluation(All) 76
[Table 38] Approved Novel Medical Devices(All) 78
[Table 39] Approved Orphan Medical Devices(All) 84
[Table 40] Item Category Certifications and Notifications by Year(2016-2020) 86
[Table 41] Item Category Certifications by Year(2016-2020) 87
[Table 42] Item Category Notifications by Year(2016-2020) 89
[Table 43] Certification of Recognized Substantial Equivalent Products by Year(2016-2020) 93
[Table 44] Certification of the Recognized Substantial Equivalent Product, "Hearing Aid, Air-Conduction," by Year(2016-2020) 95
[Table 45] Medical Devices Subject to Clinical Trial Data Submission Requirements in 2020 96
[Table 46] (Top 5) High-Frequency Items Subject to Clinical Trial Data Submission Requirements in 2020 97
[Table 47] High-Frequency Items Subject to Clinical Trial Data Submission Requirements in 2020(Except IVD Products) 98
[Table 48] Approval of Medical Devices Subject to Clinical Trial Data Submission Requirement in 2020 99
[Table 49] Conditional Approval/Certification of Medical Devices by Year(2016-2020) 105
[Table 50] Approval of Medical Devices Subject to Tracking Management by Year(2016-2020) 107
[Table 51] Approved Medical Devices Subject to Tracking Management over the Last Five Years(2016-2020) by Item 108
[Table 52] Approved Medical Devices Subject to Tracking Management over the Last Five Years(2016-2020) by Characteristic 110
[Table 53] Approval of Products Combined/Compounded with Drugs, Etc. in 2020 113
[Table 54] Approval, Certification, and Notification of Combined Medical Devices in 2020 115
[Table 55] Approval, Certification, and Notification of Combined Medical Devices in 2020 by Class 116
[Table 56] Approvals, Certifications, and Notifications of Medical Device Packages in2020 118
[Table 57] Approvals, Certifications, and Notifications of Medical Device Packages in 2020 by Class 119
[Table 58] Approval, Certification, and Notification of Combined/Compounded Items of Medical Devices/IVD Medical Devices in 2020 121
[Table 59] Approval, Certification, and Notification of Combined/Compounded Items of Medical Devices/IVD Medical Devices in 2020 by Class 121
[Table 60] Approval, Certification, and Notification of 3D-Printed Medical Devices by Year(2016-2020)(Instruments) 126
[Table 61] Approval, Certification, and Notification of 3D-Printed Medical Devices by Year(2015-2020)(Instruments) 126
[Table 62] Approved and Certified AI-Based Medical Devices over the Last Six Years(2015-2020) 132
[Table 63] Approval of Robot-Based Surgical and Rehabilitation Medical Devices by Year(2016-2020) 146
[Table 64] Robotic Surgical and Rehabilitation Medical Devices Approved Over the Last Five Years(2016-2020) 147
[Table 65] Approval, Certification, and Notification of 3D-Printed Medical Devices by Year(Medical Supplies) 153
[Table 66] Approved 3D-Printed Products in Medical Supplies Section 154
[Table 67] Approval, Certification, and Notification of 3D-Printed Medical Devices by Year(Dental Materials) 164
[Table 68] Approved 3D-Printed Products in Dental Materials Section 164
[Table 69] Formal Approval of COVID-19 Diagnostic Reagents 170
[Table 70] Approval of COVID-19 Diagnostic Reagents for Export 172
Figure 1. Overview of Approvals, Certifications, and Notifications by Year(2016-2020) 13
Figure 2. Percentages of Approved, Certified, and Notified Items Over the Last Five Years(2016-2020) 14
Figure 3. Approvals, Certifications, and Notifications by Year(2016-2020) 14
Figure 4. Approval, Certification, and Notification of Manufactured/Imported Devices by Year(2016-2020) 15
Figure 5. Revised Approval and Certification of Manufactured/Imported Devices by Year(2016-2020) 17
Figure 6. Revised Approval and Certification of Manufactured Devices by Year(2016-2020) 18
Figure 7. Revised Approval and Certification of Imported Devices by Year(2016-2020) 18
Figure 8. Approvals, Certifications, and Notifications by Class and Year(2016-2020) 20
Figure 9. Approval, Certification, and Notification of Manufactured Devices by Class and Year(2016-2020) 22
Figure 10. Approval, Certification, and Notification of Imported Devices by Class and Year(2016-2020) 22
Figure 11. Approved, Certified, and notified Items Over the Last Five Years(2016-2020) by Class 22
Figure 12. Percentages of Approvals, Certifications, and Notifications in 2020 23
Figure 13. Percentages of Approvals, Certifications, and Notifications of Manufactured/Imported Devices in 2020 23
Figure 14. Items by Section and Year(2016-2020) 24
Figure 15. Approved, Certified, and Notified Items over the Last Five Years(2016-2020) by Section 25
Figure 16. Approval, Certification, and Notification of Manufactured Devices in 2020 by Section 27
Figure 17. Approval, Certification, and Notification of Imported Devices in 2020 by Section 27
Figure 18. Approved, Certified, and Notified In Vitro Diagnostic Devices by Section in 2020 28
Figure 19. Approval, Certification, and Notification of Manufactured In Vitro Diagnostic Devices by Section in 2020 29
Figure 20. Approval, Certification, and Notification of Imported In Vitro Diagnostic Devices by Section in 2020 29
Figure 21. "Surgical Supplies(Division)" Items in 2020 46
Figure 22. "Ophthalmic Lens(Division)" Items in 2020 48
Figure 23. "Instruments for Ligature and Suture(Division)" Items in 2020 50
Figure 24. "Measuring and Introducing Instrument(Division)" Items in 2020 53
Figure 25. "IVD Reagent for Infectious Disease, Immunological Method(Division)" Items in 2020 55
Figure 26. "Tube and Catheter for Medical Use(Division)" Items in 2020 58
Figure 27. "Puncturing, Abrasion, and Perforating Instrument for Medical Use(Division)" Items in 2020 61
Figure 28. "Medical Devices for Orthopedics and Restoration(Division)" Items in 2020 63
Figure 29. "Speculums for Medical Use(Division)" Items in 2020 67
Figure 30. "Splints(Division)" Items in 2020 68
Figure 31. Item Category Certifications by Year(2016-2019) 87
Figure 32. Item Category Notifications by Year(2016-2019) 87
Figure 33. Certification of Recognized Substantial Equivalent Products by Year(2016-2020) 93
Figure 34. Percentages of Manufactured/Imported Substantial Equivalent Products Certified over the Last Five Years(2016-2020) 93
Figure 35. Certification of Recognized Substantial Equivalent Products in 2020 94
Figure 36. Certification of the Recognized Substantial Equivalent Product, "Hearing Aid, Air-Conduction," by Year(2016-2020) 95
Figure 37. Percentages of Manufactured/Imported "Hearing Aids, Air-Conduction(Substantial Equivalent Devices)" Certified Over the Last Five Years(2016-2020) 95
Figure 38. Medical Devices Subject to Clinical Trial Data Submission Requirements in 2020 96
Figure 39. Locations of Medical Device Clinical Trial Centers in Korea 99
Figure 40. Conditional Approval of Manufactured/Imported Devices by Year(2016-2020) 106
Figure 41. Conditional Certification of Manufactured/Imported Devices by Year(2016-2020) 106
Figure 42. Medical Devices Subject to Tracking Management by Year(2016-2020) 108
Figure 43. Approved Medical Devices Subject to Tracking Management over the Last Five Years(2016-2020) by Item 109
Figure 44. Approved Medical Devices Subject to Tracking Management over the Last Five Years(2016-2020) by Characteristic] 110
Figure 45. Percentages of Manufactured/Imported Combined Medical Devices Approved, Certified, and Notified in 2020 117
Figure 46. Percentages of Combined Medical Devices Approved, Certified, and Notified in 2020 by Class 117
Figure 47. Percentages of Manufactured/Imported Medical Device Packages Approved, Certified, and Notified in 2020 119
Figure 48. Percentages of Manufactured/Imported Medical Device Packages Approved, Certified, and Notified in 2020 by Class 119
Figure 49. Percentages of Manufactured/Imported Combined/Compounded Items of Medical Devices/IVD Medical Devices in 2020 122
Figure 50. Percentages of Combined/Compounded Items of Medical Devices/IVD Medical Devices in 2020 by Class 122
Figure 51. Approval of COVID-19 Diagnostic Reagents for Export 173
Figure 52. Comparison of Certification Procedures for Substantial Equivalent Products and Other Products 177