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 and section 5.4.2.1 of Health Canada's Policy on Canadian Medical Devices Conformity Assessment System (CMDCAS), the registrar noted below hereby informs the Medical Devices Bureau of the following:

  • Suspension
  • Withdrawal / Cancellation
  • Reduction of scope (*attach copy of new certificate)

of the quality management system certificate identified in section 2 of this form.

Provide details:

2. ISO 13485:2003 registration information

  • Name of registrar:
  • Certificate number:
  • Name of manufacturer:
  • Address:
  • This change to the above certificate is effective as of (YY/MM/DD):
  • Name of registrar's representative:
  • Signature:
  • Date (YY/MM/DD):
  • Number of pages (including this form):

Instructions:

  1. Fill out all applicable fields of this form.
  2. Fax or e-mail form to Health Canada within 15 days of the effective date of suspension, withdrawal / cancellation, or scope reduction.
  3. If this is to notify of a scope reduction, attach a copy of the new certificate including all attachments to the certificate.
  4. Send this form by fax to (613) 946-6758. Attention: Head, Quality Systems Section, or email a portable document format (PDF) version of the completed form to F201@hc-sc.gc.ca
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