Total 37Articles, Present Page 2/4
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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 -
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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 -
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18Regulation on Designation and Operation of Industry Standards Development Cooperation Institutes, Etc. for the Field of Medical ProductsRegulation on Designation and Operation of Industry Standards Development Cooperation Institutes, Etc. for the Field of Medical Products
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18_Regulation_on_Designation_and_Operation_of_Industry_Standards_Development_Cooperation_Institutes,_Etc._for_the_Field_of_Medical_Products.zip
2016-05-23 -