Total 39Articles, Present Page 1/4
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39Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs한국(MFDS)-싱가포르(HSA) 인공지능 의료기기의 임상시험 수행을 위한 지도 지침 (MFDS-HSA)Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs
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Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs_MFDS-HSA.pdf
2024-12-11 -
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38Regulations on Unique Device Identification Management, Etc.Regulations on Unique Device Identification Management, Etc.
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Regulations on Unique Device Identification Management, Etc..pdf
2024-04-09 -
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37Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical DevicesGuidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices
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Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices (Final Document).pdf
2024-03-29 -
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36Enforcement Rule of the Medical Devices ActENFORCEMENT 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 DevicesRegulation 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 -