Guidance on the regulatory enrolment process for medical devices: Overview
Date published: April 1, 2026
On this page
- Purpose and background
- Policy objectives
- Scope and application
- Definitions
- Acronyms
- Note about guidance documents in general
Purpose and background
The regulatory enrolment process (REP) was developed to introduce a common submission intake method across product lines, such as:
- medical devices
- prescription and non-prescription pharmaceuticals for human and veterinary use
- biologics and radiopharmaceuticals for human use
- disinfectants and
- clinical trial applications for human drugs
The REP process was also introduced for different filing formats, such as electronic common technical document (eCTD) format and non-eCTD format.
Refer to the REP Summary Table on the REP information page for dates of implementation for various product lines.
The REP is a method used by Health Canada to collect information from manufacturers related to their company, dossiers, devices, regulatory activities and regulatory transactions. It consists of a set of web-based templates that, upon completion, generate REP Extensible Markup Language (XML) files. The REP XML files within the regulatory transactions are sent to Health Canada via the Common Electronic Submissions Gateway (CESG), allowing transactions in non-eCTD normally sent on media (for example, CD, DVD) to also use the CESG.
The REP does not change the regulatory requirements for regulatory activities. This guidance document should be read in conjunction with the other resources listed.
Policy objectives
This document is intended to provide operational direction and guidance to companies and Health Canada staff on the requirements for preparing and filing regulatory activities for medical devices via the CESG using REP.
Scope and application
Medical device regulatory activities pursuant to Medical Devices Regulations (MDRs) when submitted in a table of contents (ToC) format are eligible to be filed via CESG using REP. Activities submitted in a ToC format include:
- Class II, III, IV licence applications
- Class II, III, IV licence amendments
- Class II, III, IV minor change amendments (faxbacks), including manufacturer name and address changes
- Class II, III, IV private label licence applications
- Class II, III, IV private label licence amendments
- Responses to terms and conditions (section 36 of the Regulations)
- Responses to requests for additional information (section 39 of the Regulations)
- Responses to licence suspension (section 40 and 41 of the Regulations)
Regulatory activities for the following are not in scope of REP at this time:
- investigational testing application (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 (MDRs) (for use in relation to COVID-19)
Other regulatory activities are outside of the scope of this guidance document.
Definitions
- Amendment:
-
A change to company or contact information, as it relates to the company (CO) amendment XML file. This includes a:
- change in manufacturer’s name, address, name or address of manufacturing facility and
- transfer of ownership for any medical device licences (replacement of the current manufacturer name or address change faxback (minor change) process)
- Application number:
A 6-digit unique number assigned by Health Canada for each regulatory activity submitted by companies.
- Common Electronic Submissions Gateway (CESG):
A gateway used for the secure transmission of electronic transactions sent from a sponsor to Health Canada. An account is required to use the CESG.
- Company identifier (or company code):
A 6-digit unique number assigned by Health Canada to the legal manufacturer, invoicing company or authorized regulatory correspondent.
- Dossier:
- A collection of all regulatory activities throughout the life cycle of a medical device licence.
- Dossier identifier:
- A distinctive code assigned by Health Canada to uniquely identify the dossier. It consists of a lowercase letter “m” followed by 6 numbers for medical devices.
- Draft company (CO) file:
- The XML file generated from the CO template for submitting to Health Canada.
- Enrolment:
- The process of providing Health Canada information related to a company using a draft CO file and in return receiving a company ID from Health Canada using a final CO file.
- Filing:
- The process of submitting the regulatory transaction or application information REP final XML files within a regulatory transaction.
- Final XML file:
- Health Canada-generated final CO XML file containing company and contact identifiers. Alternatively, the regulatory transaction (RT) and application information (AI) XML file generated by the company upon completion of the relevant template. This file should also be included in the regulatory transaction.
- Medical Devices Directorate (MDD):
- The Medical Devices Directorate of Health Canada is Canada's regulator of medical devices for human use.
- Regulatory activity (or application):
- A collection of all regulatory transactions throughout the process of a specific activity.
- Regulatory transaction:
- Filing of any information package sent by a company as part of a regulatory activity, such as initial data, unsolicited and solicited data (for example, initial package for a new licence application, response to a clarification request). This does not include a change to the company name or address, manufacturing facility change or transfer of ownership transactions.
- Regulatory transaction (RT) file:
- The XML file output generated from the completed REP RT template.
- REP company:
- A company that has been converted to REP through either the company enrolment process or the filing of a regulatory transaction submitted to Health Canada using the REP. All changes to company the address and contact information must thereafter be provided using the REP company template.
- REP dossier:
- A dossier that has been converted to REP through the filing of a single regulatory transaction submitted using REP. All transaction for this dossier from this point onward must also use REP.
- Template:
- Web-based forms that, upon completion, generate extensible markup language (XML) files.
Acronyms
- AI:
- application information
- CESG:
- Common Electronic Submissions Gateway
- CO:
- company
- DO:
- dossier
- ID:
- identifier
- IMDRF:
- International Medical Device Regulators Forum
- REP:
- regulatory enrolment process
- RT:
- regulatory transaction
- ToC:
- table of contents
- XML:
- extensible markup language
Note about guidance documents in general
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.