Guidance on the regulatory enrolment process for medical devices: Contacts, other resources
On this page
Contacts
Inquiries about information in the company template: devicelicensing-homologationinstruments@hc-sc.gc.ca
General inquiries about the regulatory enrolment process: ereview@hc-sc.gc.ca
Technical inquiries about setting up a CESG account: esgprep@fda.hhs.gov
Other resources
- How to pay Health Canada fees
- Filing submissions electronically
- Guidance documents for medical devices
- Documents available on the REP information page
- Health Canada IMDRF table of contents for medical device application guidance
- Guidance document - Fees for the review of medical device licence applications
- Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format