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.
- Certificate number of certificate being replaced:
- Certificate number of new or modified certificate:
- Indicate change(s) made to certificate identified above in a):
- Manufacturer's name
- Scope of Registration
- Expiry date
- Manufacturer's address
- Issue date
- 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:
Name of Signing Official (print):
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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