Guidance on Medical Device Compliance and Enforcement
(GUI-0073)

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Contact: HPFB Inspectorate Ottawa

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Health Products and Food Branch Inspectorate
Graham Spry Building, 3^rd Floor
250 Lanark Avenue
Address Locator #2003D
Ottawa, Ontario
K1A 0K9

August 22, 2008

08-120519-655

To: All Interested Parties

I am pleased to inform you that the document entitles "Guidance on Medical Device Compliance and Enforcement" (GUI-0073) is now available on the Compliance and Enforcement section of Health Canada's website under "What's New".

This guidance document states requirements and responsibilities that should be achieved by all parties in accordance with the regulatory requirements of the Food and Drugs Act (the Act) and Medical Device Regulations regarding compliance and enforcement of medical devices in Canada.

This guide "Guidance on Medical Device Compliance and Enforcement" replaces the policy aspect of the current POL-0045 document entitles "Medical Device Compliance and Enforcement Directive" published in March 2004, which contains both policy and guidance elements. This Guidance document has currently been developed to update and augment the Compliance and Enforcement Procedures.

Inquiries about this document can be address to the Medical Device Compliance Unit, Fax 613-954-0941 or by e-mail MDCU_UCIM@hc-sc.gc.ca .

Yours truly,

Original signed by

Kim Dix for
Diana Dowthwaite
Director General