Consultation on the Draft Guidance Document GD211: Guidance on the content of quality management system audit reports

The online consultation is now closed. The final guidance is available now. Comments and suggestions received from the consultation on the draft version of the guidance were reviewed and considered in the finalization of this document.

Health Canada is pleased to announce the release of the draft guidance document GD211: Guidance on the content of quality management system audit reports for a 60-day comment period. This guidance document is based on the work of Study Group 4 of the Global Harmonization Task Force (GHTF), and in particular on the technical content of GHTF document SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports.

How to Get Involved

This consultation is open for comment starting January 7, 2011 until March 8, 2011. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

MDB_enquiries@hc-sc.gc.ca

Quality Systems Section
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Main Building, Room 1605
150 Tunney's Pasture Driveway
Address Locator 0301H1
Ottawa, Ontario
K1A 0K9

Phone: (613) 957-7285
Fax: (613) 957-6345

Consultation Document: To obtain a copy of the draft guidance document that was consulted upon, please contact Medical Devices Bureau Enquiries.

Interested parties are encouraged to provide comments and suggestions by March 8, 2011.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at Medical Devices Bureau Enquiries.