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 laterInformation in this document applies to any platform.
Goal
Request the availability of below forms in argus:
- Food and Drug Administration, Ministry of Health and Welfare Medical Device Serious Adverse Event Report Form (See Attachment)
- Medical Device Adverse Event Report Form 1 (for Medical Device Handlers and Healthcare Professionals) - South Korea (See Attachment)
- Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form) Singapore (See Attachment)
Solution
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In this Document
Goal |
Solution |
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