Letter - Guidance on the Medical Device Inspection Program (GUI-0064)

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

10-115288-275

September 27, 2010

To: All Interested Parties

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Guidance on the Medical Device Inspection Program (GUI-0064)", which is now available on Health Canada's Compliance and Enforcement website under "What's New".

A notice was posted on the Health Canada website in 2009 inviting comments on the draft document between May 29, 2009 and August 12, 2009. Interested stakeholders were asked to request an electronic copy of draft document via email.

Overall, the present version of this document outlines the requirements related to changes in the medical device inspection program. As of October 1^st, 2010, the Medical Device Inspection Program will be based on risk classification assigned to observations made during inspections. An overall compliance rating will also be assigned to inspections, which is detailed in this revision of the guidance document.

Inquiries about this document can be submitted either by mail to the Manager, Medical Device Compliance Unit, HPFB Inspectorate, Graham Spry Building, A.L. #200D, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by fax at 613-954-0941, or by e-mail at MDCU-UCIM@hc-sc.gc.ca.

Yours truly,

Diana Dowthwaite
Director General