CASubmissionFormat object
Format option(s)
Paper hardcopy
Data carrier (CD-rom/DVD)
Preferred format
Data carrier (CD-rom/DVD)
Standard application form
A standard form for Notification is available on the FAMPH website.
Notification form plus 3 copies of the application file must be submitted.
Guidance on submission format
A standard form for Notification of a Clinical Investigation with Medical Devices plus a list of required documents for the complete application dossier is available on the FAMPH website in section: Human medicines > Health Products > Medical devices and their accessories >Clinical evaluation > Dossier content
