Total 28Articles, Present Page 1/3
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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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27Guideline on Review and Approval of Artificial Intelligence(AI) and big data-based Medical Devices (For Industry)Guideline on Review and Approval of Artificial Intelligence(AI) and big data-based Medical Devices (For Industry)
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Guideline on Review and Approval of Artificial Intelligence(AI) and big data-based Medical Devices (For Industry).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 -
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20Common Standards and Specifications on Electromechanical Safety of Medical DevicesCommon Standards and Specifications on Electromechanical Safety of Medical Devices
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20_Common_Standards_and_Specifications_on_Electromechanical_Safety_of_Medical_Devices.zip
2016-05-23 -
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19Common Standards and Specifications on Electromagnetic Safety of Medical DevicesCommon Standards and Specifications on Electromagnetic Safety of Medical Devices
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19_Common_Standards_and_Specifications_on_Electromagnetic_Safety_of_Medical_Devices.zip
2016-05-23 -