Total 36Articles, Present Page 1/4
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36Enforcement Rule of the Medical Devices Act New postENFORCEMENT RULE OF THE MEDICAL DEVICES ACT_Ordinance of the Prime Minister No.1819_20220721 의료기기법 시행규칙(2022.7.21.) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding and have no legal effec...
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ENFORCEMENT RULE OF THE MEDICAL DEVICES ACT_Ordinance of the Prime Minister No.1819_20220721.zip
2024-03-19 -
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35Regulation on the Permission, Notification, Review, Etc. of Medical Devices New postRegulation on the Permission, Notification, Review, Etc. of Medical Devices(No. 2022-52, July 29, 2022) 의료기기 허가/신고/심사 등에 관한 규정(2022.7.29.) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding ...
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Regulation on the Permission, Notification, Review, Etc. of Medical Devices(No. 2022-52, July 29, 2022).zip
2024-03-19 -
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34Enforcement Rule of the Act on In-Vitro Diagnostic Medical DevicesENFORCEMENT RULE OF THE ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES(20201231) 체외진단의료기기법 시행규칙(20201231) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding and have no legal effect for complian...
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ENFORCEMENT RULE OF THE ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES(20201231).zip
2024-03-08 -
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33Instructions on Labeling and Management of Unique Device IdentifiersInstructions on Labeling and Management of Unique Device Identifiers
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Instructions on Labeling and Management of Unique Device Identifiers_Word.zip
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Instructions on Labeling and Management of Unique Device Identifiers_Pdf.zip
2023-10-17 -
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32Regulations on Labeling and Description of Medical DevicesRegulations on Labeling and Description of Medical Devices
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Regulations on Labeling and Description of Medical Devices(No.2020-71)_Pdf.zip
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Regulations on Labeling and Description of Medical Devices(No.2020-71)_Word.zip
2023-10-17 -
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31Standards of Medical Device Good Manufacturing Practices_RevisedStandards of Medical Device Good Manufacturing Practices_Revised
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Standards of medical device Good Manufacturing Practice_Pdf.zip
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Standards of medical device Good Manufacturing Practice_Word.zip
2023-10-17 -
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30Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical DevicesThis guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyze medical...
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Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices.pdf
2023-07-20 -
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29Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical DevicesThis guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS) an...
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Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices.pdf
2023-07-20 -
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28Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19
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Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19.pdf
2020-11-04 -
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27Guidance on the Review and Approval of Digital Therapeutics(DTx)(Revision)This guidance shall apply to the approval/certification of the manufacturing/import, review of technical documents, and approval of clinical trial protocols for a DTx that provide evidence-based therapeutic intervention to patients for preventing, managing, or treating medical disorders or diseases....
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Guidance on the Review and Approval of Digital Therapeutics(DTx).pdf
2020-11-04 -