BfArM - Federal Institute for Drugs and Medical Devices

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FSCA Report Form (Initial, Final and Follow-up) according to § 3 (1) of the Ordinance on Medical Devices Vigilance by the Manufacturer, Authorised Representative or Importer (or Distributor)

PDF-Form (use of Adobe Acrobat 9.X recommended, not barrier-free)

Form PDF, 1MB, File does not meet accessibility standards