Guidance on the regulatory enrolment process for medical devices: Transmission via CESG

All regulatory transactions must be validated according to the Validation rules for regulatory transaction filed in non-eCTD format before filing.

Transactions that fail validation will not be accepted.

All regulatory transactions using the REP must be sent to Health Canada via the CESG. Before using the CESG, stakeholders must register as a trading partner.

For information on how to become a trading partner and how to send transactions, refer to the CESG information page.