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:
- a single process for all regulatory transactions
- will eliminate the use of media (such as CDs and DVDs) to transmit transactions to us
- will expand the scope of the CESG to allow regulatory transactions in non-eCTD format
- regulatory activities filed through the CESG with the REP
- is more efficient and secure compared to using courier and email
- web-based REP templates for easier and faster data entry
- features include drop-down lists, predictive text and help text
- easier method for uploading data into Health Canada systems, as REP files sent by manufacturers are in XML format
- will enhance accuracy, consistency and reliability of the information captured
When to use the REP
The REP is available for the following activities:
- Class II, III and IV licence applications
- Class II, III and IV licence amendments
- Class II, III and IV minor change amendments (faxbacks), including manufacturer name and/or address change
- Class II, III and IV private label applications
- Class II, III and IV private label amendments
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:
- investigational testing applications (ITA)
- medical device establishment licence (MDEL) applications
- for example, Class I medical devices
- Special Access Program (SAP) applications
- medical devices regulated under Part 1.1 of the Medical Devices Regulations (for use in relation to COVID-19)
How to use the REP
Before using this process for the first time, manufacturers should become familiar with the following:
- REP templates
- help instructions
- CESG requirements
- REP medical device guidance document
These items will be posted on our REP information web page by December 2023.
Announcement
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 devicelicensing-homologationinstruments@hc-sc.gc.ca.
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