Regulatory Enrolment Process (REP) for Medical Devices

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

REP Template & Form Links

Outside the Regulatory Transaction Process

Company (CO) Template (2024-12-11)

Dossier ID Request Form for Medical Devices

Within the Regulatory Transaction Process

Regulatory Transaction Template (2024-12-11)

Application Information Template (2024-12-11)

Device Details (2023-12-01)

Application Attestation Form (2024-01-15)

Stylesheet Download Links