Guidance on the regulatory enrolment process for medical devices: Regulatory enrolment process

On this page

• Templates and forms
• Summary of the REP
• Company enrolment and amendment process
• Dossier ID request process
• Application process

Templates and forms

REP uses XML files generated by web-based templates for transmission to Health Canada, instead of using PDF forms. The following templates/forms are used to capture the necessary information related to company, dossier, transaction, and application respectively:

• company (CO) template
• dossier ID request form for medical devices
• regulatory transaction (RT) template
• application information (AI) template

Collectively, these templates and forms are used in 3 distinct processes:

• company enrolment and amendment
• dossier identifier (ID) request
• filing a regulatory transaction (application)

These templates replace the following forms:

• Class II, III and IV new licence application forms
• Class II, III and IV licence amendment forms
• all faxback (minor change) forms and
• private label licence application forms

Summary of the REP

The following summary provides a high-level walk-through of the steps to consider when you begin to use the REP. The sections with the detailed requirements are specified in each step. Be sure to read the entire guidance thoroughly before using the REP.

CESG account: All regulatory transactions using the REP must only be sent to Health Canada via the CESG. If you do not have a CESG account refer to the guidance on filing submissions electronically.

New company: If your company has never filed a regulatory transaction to Health Canada for medical devices, then you will need to obtain a “company identifier (ID)” and contact identifiers (IDs) by using the REP company (CO) template.

Refer to the section on company enrolment and amendment process for information on the CO template and the process for enrolling your company. Note that it can take up to 1 week to obtain your company ID once you have provided all the necessary information.

Existing company: If you have previously filed a medical device regulatory transaction to Health Canada and you do not know your company ID, email the Medical Devices Directorate.

Refer to the section on company enrolment and amendment process for information on the CO template and the process for amending your company information.

New dossier: If you are filing a regulatory transaction for a new dossier for which a dossier identifier (ID) has not yet been assigned, you will need to submit a dossier ID request form.

Refer to the section on the dossier ID request process for information on this form and its requirements. Note that it can take up to 1 week to obtain your dossier ID once you have provided all the necessary information.

Existing dossier: If you have previously filed a regulatory transaction to Health Canada for this particular dossier and you do not know your dossier ID, email the Medical Devices Directorate.

Filing a regulatory transaction (application): Once your CESG account is set up and you have your company IDs, contact IDs and dossier ID, you are ready to file a regulatory transaction using the REP. Prepare your regulatory transaction as per the regulatory requirements using ToC. However, instead of completing the PDF application forms, you must complete the REP regulatory transaction (RT) template and the application information (AI) template (when required).

Refer to the section on application process for information on the process and conditions related to the RT and AI templates.

Refer to the section on application information (AI) template and process for when the AI file should be included in the regulatory transaction filed for review.

The RT and AI files should be included within the regulatory transaction as instructed in the sections on naming conventions and folder structures.

Once your regulatory transaction is ready for filing, refer to the section on transmission via CESG.

Note: Each regulatory transaction filed to Health Canada for a REP dossier must include a RT file (for example, the initial transaction for a regulatory activity, a transaction for the response to additional information request).

Company enrolment and amendment process

The company enrolment process, using the CO template, is intended to ensure that Health Canada has the most up-to-date company and contact information at all times. It is the company’s responsibility to ensure that the information captured in the final CO XML file is updated as required.

With REP, the company enrolment and amendment process can be completed at any time and is independent from the regulatory transactions filed for review.

New company enrolment

To complete the CO template, follow the instructions outlined in this section. Once complete, click the “Submit to Health Canada” button to generate an email template with all the details auto-filled. Be sure to attach the draft CO XML file from your local computer before sending. If the email template is not automatically generated, follow the instructions under the “Submit to Health Canada” button on the CO template for email details.

After verification by Health Canada, the company will receive the final CO XML file by email. The final CO file will contain the company ID and contact IDs, which should be used to complete subsequent REP templates.

Amend company enrolment

To amend company or contact information, you must upload the latest final company XML file received from Health Canada and click the “Amend enrolment” button.

• If company representative details have changed, update the contact details and click the “Revise contact” button.
• If a contact is no longer active, click the “Delete contact” button.
• To add a new company representative, click the “Add contact” and “Save contact” buttons after completing all of the required fields.

The amendment process is repeated each time the information on the latest CO file needs updating. Failure to use the most recent final CO XML for amendments will result in delays.

Companies that know their company ID but do not have their final company XML file can request a copy of their CO. To do so, send an email to devicelicensing-homologationinstruments@hc-sc.gc.ca with the following information:

• Subject line:
  • MD REP – CO request – <Insert Company ID here>
• Body:
  • company name
  • company ID
  • medical device licence numbers (if applicable)
  • contact information where CO should be sent

Note: This contact must have had previous correspondence with Health Canada as a member of the company in question

Instructions for the CO template and the enrolment process

1. Access the online template from the REP information page.
2. Enter the information in the required fields. Instructions can be found by clicking the numbered hyperlink on the right side of specific sections or fields.
3. If a template is partially completed, click on the “Save working copy” button at the bottom of the template to save a copy on the local workstation for completion later. The file will be saved in the “.hcsc” file format. The working copies (files with extension .hcsc) should never be sent to Health Canada.
   To resume completing the template, the working copy file should be uploaded back into a blank CO template using the “Choose file” button near the top of the template.
4. Once the template is completed with all the required fields, click the “Save draft XML” button near the bottom of the template to save the XML file on your local workstation.
5. If there are errors, the XML will not be generated. The errors will be presented near the top of the template. A specific error may be selected to go directly to the section or field that needs to be corrected.
6. Once the draft CO XML file is generated, it is ready to be sent to Health Canada.
7. Click on the “Submit to Health Canada” button near the bottom of template to create an email with the email address and subject pre-filled using your local email client application. Attach the draft CO XML file to the email before sending to Health Canada.
   • If your email client is not configured on your computer or the “Submit to Health Canada” button does not automatically launch your default email client application, follow the instructions at the bottom of the CO template.

Instructions for amending a final CO XML file

1. Load the most recent final CO file (received from Health Canada) into a blank CO template using the “Choose file” button near the top of the template.
2. Select the “Amend enrolment” button before making any changes.
3. Make the necessary revisions.
4. Follow steps 2 to 7 in the previous section on instructions for CO template and enrolment process.

Health Canada may request clarification by email by responding to the sender that filed the draft CO XML file. After verification, Health Canada will update the internal database and assign a new company ID, if applicable. Health Canada will return the final CO file by email by responding to the sender that filed the draft CO XML file. The final CO file will contain the company ID, which will be required to complete the dossier ID request form and the RT and AI templates. Company ID is also indicated as the 5-digit number within the CO XML file name (for example, final-com-K18276-2022-03-16-1204.xml).

This process can take up to 5 business days. If you require a status update and the processing of your company enrolment and amendment has been more than 5 business days, email Health Canada at devicelicensing-homologationinstruments@hc-sc.gc.ca. To ensure that this does not cause delays with any forthcoming regulatory transactions, the company enrolment and amendment should be completed as early as possible.

Note the following conditions:

• Each company that interacts with Health Canada must enroll their company (for example, manufacturer, invoicing company, regulatory correspondent). Once the company is enrolled in REP, all company information updates must be provided using the CO template for all REP and non-REP dossiers. If the regulatory correspondent for questions related to specific regulatory activities or medical device licences is a third party, they must enrol their own company for a separate CO xml.
• The company ID and contact IDs obtained via enrolment should be shared with the manufacturer or regulatory correspondent, so that they can reference the appropriate IDs when completing the RT template.
• Companies should allow a minimum of 7 business days for the company enrolment and amendment process. However, to ensure that this does not delay any forthcoming regulatory transactions, companies are encouraged to initiate a company enrolment before filing a regulatory transaction to Health Canada.
• If there are changes to the company name, company address, manufacturing facility address or a transfer of licences from another manufacturer, all impacted licences should be identified on the CO file. Upon Health Canada’s verification, a final CO XML file and updated copies of all impacted licences will be returned to the manufacturer (replacement of the current manufacturer name or address change faxback process).
• All supporting documents that are required to support any of these changes should be submitted to Health Canada along with the draft CO XML file.
• If licence ownership is being transferred, follow the details on the CO template and provide all necessary details as instructed to prevent delays.
• If your company information has changed (for example, buyouts, mergers, name change) and a regulatory transaction will need to be filed, be sure to complete the company enrolment and amendment process before filing the regulatory transaction. This is because a new company ID may need to be assigned.

Figure 1: Text description

The following process map shows the key steps in enrolling or amending a company profile with Health Canada.

Steps

1. Do you have a final CO XML file?
   • If yes, proceed to step 2.
   • If no, proceed to step 4.
2. Is your final CO XML file up to date?
   • If yes, proceed with REP process using your Company ID.
   • If no, proceed to step 3.
3. Amend your final CO XML file by uploading it into the blank CO template and selecting the “Amend enrolment” button, making the required modifications. Proceed to step 5.
4. Complete a new CO template to enrol your company.
5. Submit the draft CO XML generated by the CO template to Health Canada via email.
6. Health Canada will verify the information submitted on the draft CO XML and populate internal systems accordingly. A final CO XML will be generated by Health Canada and issued to the company via email.

Dossier ID request process

A dossier is a collection of all regulatory activities throughout the lifecycle of a licence. The dossier identifier (ID) is assigned by Health Canada to uniquely identify the dossier. It consists of a lowercase letter “m”, followed by 6 numeric digits.

The purpose of the dossier ID request process is for manufacturers to obtain an identifier for a dossier by submitting a completed dossier ID request form to Health Canada. Once Health Canada has received all the essential information, a unique dossier ID will be assigned. The manufacturer will require this before completing the REP templates for the regulatory transaction filing process and for creating the top-level folder name. If the wrong dossier ID is used, delays may occur or your transaction may be rejected.

When to request a dossier ID

Completing a dossier ID request form for a regulatory transaction that you intend to file is only required if the transaction is for a new dossier (a dossier ID has not yet been assigned).

Manufacturers that hold an active medical device licence are able to request a complete listing of their existing dossier IDs by emailing us at devicelicensing-homologationinstruments@hc-sc.gc.ca with the following information:

• Subject line:
  • MD REP – DO request
• Body:
  • company name
  • company ID
  • medical device licence numbers (if applicable)
  • contact information where DO should be sent

Note: This contact must have had previous correspondence with Health Canada as a member of the company in question.

Instructions for dossier ID request form and process

The dossier ID request form:

• is accessible by clicking on the appropriate form link on the REP information page.
  • Be sure to select the correct link as the completed form will be submitted to a different Health Canada group depending on the dossier type.
• generates an automatic email sent to Health Canada once it has been completed and the “Submit” button is clicked
• does not generate an XML file
• should be completed as per the instructions provided on the “Help text” section of the form
• will prompt a thank you page if submitted successfully
  • The primary contact should receive a copy of the completed form at the email address listed in the form.
  • If after clicking the “Submit” button you do not receive a thank you page or the primary contact does not receive a copy of the completed form by email, contact us at devicelicensing-homologationinstruments@hc-sc.gc.ca to ensure we received your request.

An email will be sent to the primary contact if more information is required. Otherwise, a dossier ID will be assigned and sent to the primary contact within a week from the request.

Note the following conditions:

• Companies are expected to include any relevant information, including any related licences and previous transactions, in the “Additional field for context” to assist with the review of the request.
• Companies should allow a minimum of 5 business days for the dossier request process. However, to ensure that this does not cause delays with any forthcoming regulatory transactions, companies may initiate a dossier request before filing a regulatory transaction to Health Canada.
• If Health Canada requires more information, the primary and alternate contacts will be contacted by email.

Figure 2: Text description

The following process map shows the key steps in requesting a new Dossier ID which will be required for filing a subsequent regulatory transaction such as a new medical device licence application.

Steps

1. Do you have an up-to-date final CO XML file associated with this dossier?
   • If yes, proceed to step 3.
   • If no, proceed to step 2.
2. Enrol your company or amend your final CO XML through the company enrolment process.
3. Do you have a dossier ID?
   • If yes, proceed with REP using your existing dossier ID.
   • If no, proceed to step 4 to request a dossier ID.
4. Complete and submit a new dossier ID request form to Health Canada.  
5. Health Canada will validate the information submitted on the dossier ID request form and populate internal systems accordingly. A dossier ID will be generated by Health Canada and issued to the company via email.

Application process

The application process pertains to the remaining 2 REP templates:

• regulatory transaction (RT) template and
• application information (AI) template

Using these templates, final REP XML files can be generated by the company when needed and do not need to be finalized by Health Canada in advance. These files should be included within a regulatory transaction to be filed to Health Canada.

A regulatory transaction containing final REP XML files must not include any of the following forms:

• Class II, III or IV new licence application form
• licence amendment application form
• minor change (faxback) form and
• private label licence application form

The information from these forms is superseded by the information in the REP XML files. If these forms are filed in a regulatory transaction along with a REP XML file, the transaction may be rejected.

Refer to Figure 4 for the placement of the final RT and AI XML files in the application folder structure.

The device details spreadsheet is required for all new licence applications and any amendment applications that may impact a manufacturer’s catalogue listing. A signed attestation form must also be completed for the initial transaction of a new regulatory activity.

Refer to Figure 4 for the placement of the device details spreadsheet and the signed attestation form in the application folder structure.

Files should not have any additional security settings. For example, a file:

• should not have password protection, restricted access, Digital Rights Management (DRM) or Information Rights Management (IRM) that prevents it from opening
  • Files with these settings may be blocked by our organization’s security policies, preventing us from accessing them.
• should be set to allow printing, selecting text and graphics, and adding or changing notes and form fields

Instructions for RT and AI templates and the application process

1. Access the online templates from the REP information page.
2. Enter the information in the required fields. Instructions can be found by clicking the numbered hyperlink of specific sections or fields.
   • The fields on the templates are built interdependently, meaning various picklists are tailored to the selections you make in previous fields.
   • Be sure to select the correct items from the picklists to avoid delays in the processing of your transaction.
3. If a template is partly completed, click the “Save working copy” button at the bottom of the template to save a copy on the local workstation for completion later.
   • The file will be saved in the “.hcsc” file format.
   • The working copies (files with extension .hcsc) should never be sent to Health Canada.
   • To resume completing the template, the working copy can be loaded back into a blank RT or AI template using the “Choose file” button near the top of the template.
4. Once the template is completed with all the required fields, click the “Generate Final XML” button found near the bottom of the template to save the XML file on the local workstation.
   • Any errors will be presented near the top of the template. A specific error may be selected to go directly to the section or field that needs to be corrected.
5. Once the final XML file is generated, it must be sent to Health Canada within a regulatory transaction submitted for review.
   • Refer to the sections on folder structure and naming conventions, and transmission via the CESG for detailed instructions.
6. To pre-populate a blank template using a previously generated XML file, upload the file into the corresponding blank template (for example, the RT file into the RT template) using the “Choose file” button near the top of the template. Revise the information as needed.

Regulatory transaction (RT) template and process

The regulatory transaction template collects information pertaining to the:

• regulatory activity and transaction (for example, application number, regulatory activity type, transaction description) and
• regulatory contact identifier for this regulatory activity or transaction

Note the following conditions:

• Once a company files a regulatory transaction containing a final RT file, that dossier is considered an REP dossier. All subsequent regulatory transactions must also contain the required REP files as transactions missing a correct REP file will be rejected.
• When viewing a final RT file, upload the file into a blank RT template.
• A new or revised RT file must be created for each regulatory transaction containing the information pertaining to that transaction. Do not submit a previously filed RT XML file without updating the required information.
• When creating a final RT file for a subsequent regulatory transaction, upload a recent final RT file into a blank RT template to prepopulate all the fields. Note it is the company’s responsibility to ensure the pre-populated information is accurate.

The following guidelines can help complete the RT template:

• A previously submitted RT file may be uploaded into a blank template to pre-populate the fields.
  • Be sure to revise all the required fields pertaining to the regulatory transaction you are currently filing.
  • The pre-populated information must be accurate and applicable before an updated RT file is generated. The information in the RT must align with the information in the cover letter.
  • If conflicting information is provided, processing delays will occur as Health Canada needs to confirm the intent to accurately process the transaction.
• Select the items in each picklist field (especially regulatory activity types, and transaction description) carefully.
  • Your selection in a given field will, in most cases, determine the picklists displayed in other subsequent fields.
  • Incorrect selections could delay the processing of the transaction or possible improper routing of the transaction.
• The designated regulatory contact provided on the RT template is the individual that will be contacted for regulatory questions related to that regulatory activity. A contact may be updated as part of a subsequent transaction (for example, response to clarification request).
  • It is important keep this information up to date.
  • Updates to the regulatory activity may be filed as a subsequent transaction containing an updated RT file referencing the correct application number with the new contact information
  • Updates should be filed as “unsolicited information” (as the transaction description).

Figure 3: Text description

The following process map shows the key steps required for completing the regulatory transaction template process. This process collects information such as the regulatory activity being performed as well a description of the transaction.
Steps

1. Do you have a valid company ID and is all company and contact information with Health Canada up-to-date?
   • If yes, proceed to step 3.
   • If no, proceed to step 2.
2. Enrol your company or amend your final CO XML through the company enrolment process.
3. Do you have a dossier ID?
   • If yes, proceed to step 5.
   • If no, proceed to step 4.
4. Request a dossier ID through the dossier ID request process.
5. Complete the RT template for a new or existing regulatory activity. Once completed generate a final RT XML file.

Application information (AI) template and process

The AI template collects information related to the application and its corresponding devices. To complete the AI template, follow the steps outlined in the section on the application process and include it within the regulatory transaction.

The following conditions must be noted:

• The final AI file is not required in every transaction filed to Health Canada.
• A final AI file must be included within the initial transaction for the following regulatory activities:
  • new licence application (Class II, III, IV)
  • licence amendment application (Class II, III, IV)
  • private label licence application (Class II, III, IV)
  • private label licence amendment application (Class II, III, IV)
• An updated final AI file must be included in the next transaction for a regulatory activity only if:
  • information provided in the most recent final AI file for that regulatory activity has changed or
  • Health Canada has requested an updated final AI file in the form of a request for clarification.
  • Note that if the final AI file is missing, the regulatory transaction may be rejected.
• When updating a final AI file, load the file into a blank AI template and revise the relevant fields.
• It is the company’s responsibility to ensure the pre-populated information is accurate.