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:

  1. Fill out all applicable fields of this form.
  2. 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 MDSAP certificate including all attachments to the certificate.
  4. E-mail a portable document format (PDF) version of the completed form to hc.f201.sc@canada.ca
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