Total 30Articles, Present Page 1/3
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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 -
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26Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry)Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry)
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Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry).pdf
2020-11-04 -
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25Act on In Vitro Diagnostic Medical DevicesAct on In Vitro Diagnostic Medical Devices
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체외진단의료기기법(16433)_영문_최종.hwp
2020-06-03 -
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24Brochure for Korean Medical Device(English Version)Brochure for Korean Medical Device(English Version) Contents - Korean Medical Device Market status - Korean Medical Device Regulation - Marketing Authorization/QMS/Recalls ~ - R&D for Medical Device - List of Reference materials for IVDs
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Medical Device_Brochure_Eng.pdf
2019-06-05 -
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23Guidance on Patient-matched Medical Devices manufactured using 3D printersGuidance on Patient-matched Medical Devices manufactured using 3D printers (published on December 10th, 2015)
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Guidance for Patient-matched Medical Devices Manufactured using 3D printers.pdf
2018-07-26 -
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22Medical Device Standards and SpecificationsMedical Device Standards and Specifications
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22_Medical_Device_Standards_and_Specifications.zip
2017-07-26 -
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21Common Standards and Specifications on Biological Safety of Medical Devices (Addendum)Common Standards and Specifications on Biological Safety of Medical Devices (Addendum)
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21_Common_Standards_and_Specifications_on_Biological_Safety_of_Medical_Devices_(Addendum).docx외_1개.zip
2017-07-26 -