Implementing the regulatory enrolment process (REP) for medical devices regulatory activities: Revised notice

November 15, 2023
Our file number: 23-109835-170

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The REP pilot

The Health Products and Food Branch (HPFB) is implementing the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities. Our decision is based on the results of a pilot project, which began in November 2019 and will end in June 2024. About 40 companies participated in the pilot.

The pilot was positive. All medical device companies are now invited to begin to use this process beginning in July 2024.

At the moment, the REP is voluntary.

About the REP

The REP will be used to collect information from manufacturers on the company, dossiers, devices, regulatory activities and transactions. It consists of a set of web-based templates that generate REP Extensible Markup Language (XML) files upon completion.

Our goal is to implement a common submission intake approach for all product lines. This includes the following:

When to use the REP

The REP is available for the following activities:

All regulatory submissions must be prepared using the International Medical Device Regulators Forum (IMDRF) table of contents format.

The following activities are not part of the REP:

How to use the REP

Before using this process for the first time, manufacturers should become familiar with the following:

These items will be posted on our REP information web page by December 2023.


Health Canada intends to make REP mandatory within 18 months from the implementation date.

Contact us

For questions about this notice or about the REP in general, email us at

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