Form F202 - Submission of a New or Modified Quality Management System Certificate

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Contact: Device Licensing

1. Pursuant to subsection 43.1 and subject to section 34of the Medical Devices Regulations, the manufacturer noted below hereby submits a new or modified quality management system.

  1. Certificate number of certificate being replaced:
  2. Certificate number of new or modified certificate:
  3. Indicate change(s) made to certificate identified above in a):
    • Manufacturer's name
    • Scope of Registration
    • Expiry date
    • Manufacturer's address
    • Standard
    • Registrar
    • Locations
    • Issue date
    • Other:
  4. Licence numbers to which this new/modified certificate applies (enter or attach list):

2. Manufacturer Information

I, the manufacturer holding the certificate identified in 1.a), hereby submit a new or modified version of my quality system certificate in accordance with subsection 43.1 of the Medical Devices Regulations.

Name of manufacturer:

Address:

Name of Signing Official (print):

Signature:

Date (year/month/day):

Instructions:

Do not send new or modified certificates before their effective date. Mail or fax a copy of this form with an attached copy of your new or modified certificate, including all its attachments and the list required in 1d) if need be, to:

Section Head, Regulatory and Scientific Section
Medical Devices Bureau
Therapeutic Products Directorate, Health Canada
2934 Baseline Road, Tower B
Address Locator: 3403A
OTTAWA, Ontario  K1A 0K9
Fax to: (613) 957-6345 Attention: Section Head, Regulatory and Scientific Section

F202 June 2010

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