CASubmissionFormat object
Format option(s)
Paper hardcopy
Electronically
Preferred format
e- service for notification of clinical investigation
Online portal
The online portal "Medical device – e-service for notification of clinical investigation" for upload and submission of application form and attachments can be accessed via the MPA website in section Medical Devices > Clinical Investigations > Notification and Forms.
Standard application form available
Yes
Standard application form
"Form for notification clinical investigation" + "Guidance for use of notification form": available on the MPA website in section Medical Devices > Clinical Investigations > Notification and Forms
Additional Information
A copy of the application to the concerned Ethical Review Board may be attached (and its decision and statement if available when the notification is submitted).
