Guidance on the regulatory enrolment process for medical devices: Naming conventions, folder structure
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File naming conventions
All REP XML file names are generated by the templates and must not be modified. Examples of the REP XML file names are displayed in Table 1.
| XML file | Sample naming convention | Description |
| Draft | draft-com-yyyy-mm-dd-hhmm.xml | Generated by the company upon completion of the company template |
| Amended | draft-com-K123456-yyyy-mm-dd-hhmm.xml | Generated by the company upon updating the company template |
| Final | final-com-K123456-yyyy-mm-dd-hhmm.xml | Generated by Health Canada upon receipt of a Draft or Amended CO |
| rt-m123456-yyyy-mm-dd-hhmm.xml ai-m123456-yyyy-mm-dd-hhmm.xml |
Generated by the company upon completion of the RT or AI template |
The date contained in the file name of the CO files can help to identify the most recent file, which can be used by the company for loading into a blank template to amend.
Modifying the name or extension of any of the XML files may delay processing done by Health Canada and may lead to the rejection of applications.
Folder structure
Final RT and AI XML files should be placed in folder 1.04 Application Form-Administrative Info (Figure 4).
The device details spreadsheet should be placed in folder 1.05 Listing of device.
For detailed information on the structure and filing a regulatory transaction in ToC format, refer to Health Canada’s guidance on IMDRF table of contents for medical device applications. The structure of the transaction depends on the type of transaction that is being submitted.
Note that companies should include on their cover letter the name and email of their contact to whom the validation reports should be sent to.
Figure 4: Example folder structure for ToC format
Figure 4: Text description
The figure is an example folder structure for an REP submission in ToC format. The top level folder is labelled with the Dossier ID while the subsequent folders follow the IMDRF ToC structure, which are populated with the corresponding submission documents by the manufacturer.
Final REP XML files such as the RT and the AI templates are found under section 1-REG ADMIN in the 1.04-Application Form-Administrative info subfolder, alongside the application attestation form, while the device details spreadsheet should be filed under the 1.05-Listing of Device(s) subfolder.