Regulatory Enrolment Process (REP) for Medical Devices

REP Template & Form Links

In order to access the most up-to-date version of the template, please be reminded to delete your cache frequently and “refresh” the template links on your web browser prior to each use

Outside the Regulatory Transaction Process

Company Template (July 31, 2024)

Dossier ID Request Form for Medical Devices

Within the Regulatory Transaction Process

Regulatory Transaction Template (July 31, 2024)

Application Information Template (July 31, 2024)

Device Details (December 1, 2023)

Application Attestation Form (January 15, 2024)

Stylesheet Download Links