Form F201 Change of a Manufacturer's Registration Status
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1. Pursuant to sections 32.3 and 32.4 of the Canadian Medical Devices Regulations, the Auditing Organisation (AO) noted below hereby informs the Medical Devices Directorate of the following:
- Suspension
- Withdrawal / Cancellation
- Reduction of scope (*attach copy of new certificate)
of the MDSAP quality management system certificate identified in section 2 of this form.
Provide details:
2. MDSAP ISO 13485:2016 registration information
- Name of Auditing Organisation (AO):
- MDSAP Certificate number:
- Name of manufacturer:
- Address:
- This change to the above MDSAP certificate is effective as of (YY/MM/DD):
- Name of Auditing Organisation’s representative:
- Signature:
- Date (YY/MM/DD):
- Number of pages (including this form):
Instructions:
- Fill out all applicable fields of this form.
- E-mail form to Health Canada within 15 days of the effective date of suspension, withdrawal / cancellation, or scope reduction.
- If this is to notify of a scope reduction, attach a copy of the new MDSAP certificate including all attachments to the certificate.
- E-mail a portable document format (PDF) version of the completed form to
f201@hc-sc.gc.ca