Guidance on the regulatory enrolment process for medical devices: Important considerations

This section provides important considerations and reminders.

REP templates are often updated to fix such things as identified bugs and to update picklists. However, the links for the templates will remain the same. To ensure you are accessing the most up-to-date templates, refresh the REP template page before every use and frequently delete the cache on your computer.

All updated templates are backwards compatible. You can still upload previously generated XML files into newer templates to view and pre-populate the fields.

• If new fields are introduced, you may see an error that must be addressed before a new XML file can be generated.
• Information from a previous XML will not be displayed in its entirety if fields have been removed.

The REP working copy (.hcsc), draft and final XML files will be saved in the location set by the browser as the default. Companies should use proper document management practices to file away documents and not keep them in the default location as multiple file names may be similar.

You should submit 1 application per licence you wish to amend. This amendment can include multiple changes within the device detail spreadsheet. For example, if 3 devices are being added to licence number XXXXX, only 1 REP application should be submitted instead of 3 separate ones.

Inaccuracies cause delays, as Health Canada needs to confirm the intent of the transaction to process it accurately. For instance, modifying the name or extension of any of the XML files may delay processing and lead to the rejection of applications. You can prevent delays by ensuring that the information provided in the RT template matches the content of the cover letter and that all fields entered in the RT are accurate (for example, dossier type and dossier ID).

The working and final AI or RT files can be used to pre-populate the fields by uploading into the appropriate blank template. However, be cautious when pre-populating with previously generated files as the information must reflect the new product or new regulatory transaction.

If you are using the AI template for kits or co-packaged products, contact the medical device review bureau for more instructions, as the approach may differ depending on the composition of the final products.

Stylesheets for all templates (CO, RT, AI) are available on the REP website in the section on templates, stylesheets and forms.