Health Canada Form F202 is the submission medical device manufacturers use to have Health Canada’s Medical Devices Bureau recognize a new ISO 13485 Quality Management System certificate or a modification to one already on file.1Health Canada. Form F202 for Filing a New Quality Management System Certificate or a Modification to an Existing Certificate You file it alongside the certificate itself, and the form routes new filings and modifications down different review paths.
Who Files Form F202
The form is for medical device manufacturers that need Health Canada to recognize a QMS certificate issued under ISO 13485. Two situations trigger it: a brand-new certificate being filed for the first time, and a modified certificate reflecting changes to the quality system, manufacturing site, or scope of device production.
If your company holds a Medical Device Establishment Licence or is applying for one, your QMS certificate is a foundational piece of that regulatory file. A lapsed or unrecognized certificate can stall device reviews and market authorizations, so filing F202 promptly after any certificate change prevents downstream delays.
What To Have Ready Before You Start
- Your current ISO 13485 certificate from a recognized auditing organization. For a modification, keep both the previous and updated certificates available.
- Company and site details: legal name, the address of each manufacturing or processing site covered by the certificate, and any MDEL numbers already on file with Health Canada.
- The scope of the certificate: a clear description of the device types and activities, such as design, manufacturing, sterilization, or distribution.
- Audit information: the auditing body, audit dates, and any findings or corrective actions if the certificate was modified in response to an audit outcome.
Match every name, address, and licence number exactly to what Health Canada already has for your company. Clerical mismatches are a common cause of clarification requests.
Completing the Form
Form F202 is available on the Health Canada website under the medical devices quality systems section.1Health Canada. Form F202 for Filing a New Quality Management System Certificate or a Modification to an Existing Certificate Mark clearly whether you are submitting a new certificate or a modification, because the Bureau handles the two differently.
Fill the fields using the information from the certificate itself. The scope description should mirror the wording on the certificate rather than paraphrase it, since reviewers compare the two documents side by side. If the certificate covers multiple manufacturing sites, list each site and its specific activities individually.
Submitting and Handling Follow-Up
Send the completed form and a copy of the ISO 13485 certificate to Health Canada’s Medical Devices Bureau. Health Canada accepts electronic submissions for most medical device regulatory filings, and you should receive confirmation that the filing has entered the review queue.
If reviewers find gaps or inconsistencies between the form and the certificate, they will send a written request for clarification. Respond promptly. Delays extend your overall processing timeline, and an unresolved request can leave the submission considered incomplete.
Keeping the Certificate Current
Once Health Canada accepts the filing, the recognized certificate becomes part of your regulatory profile. File a fresh F202 whenever your auditing body issues a renewal, or when you make a significant change: a new manufacturing site, an expanded device scope, or a change in auditing organization. Updating proactively is faster than waiting for the discrepancy to surface during a device review.