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Information About Attached Forms Availability In Argus (FDA MHLW MD SAE Form, MDAER Form 1, MDAR1 Form) (Doc ID 3000825.1)

Last updated on JANUARY 29, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.4 and later
Information in this document applies to any platform.


Request the availability of below forms in argus:

  1. Food and Drug Administration, Ministry of Health and Welfare Medical Device Serious Adverse Event Report Form (See Attachment)
  2. Medical Device Adverse Event Report Form 1 (for Medical Device Handlers and Healthcare Professionals) - South Korea (See Attachment)
  3. Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form) Singapore (See Attachment)



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