By Stewart Eisenhart, Emergo Group
Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Program Reporting Program (CVMD), beginning October 3, 2011.
The change will impact firms with Medical Device Establishment Licenses and Canadian Medical Devices Conformity Assessment System accreditations.
Responsibility for HC’s MPR procedure has moved from the regulator’s Health Products and Food Branch Inspectorate to its Marketed Health Products Directorate. The CVMD falls under HC’s Canada Vigilance program for post-market surveillance of health products.
From October 3rd, device manufacturers and importers should send MPRs to the following address:
Canada Vigilance-Medical Device Problem Reporting
Marketed Health Products Directorate
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
Fax: 613.954.0941
Email: mdpr@hc-sc.gc.ca
HC is also updating associated documents—the Guidance Document for Mandatory Problem Reporting of Medical Devices (GUI-0059) and the Mandatory Problem Reporting Forms for Industry (FRM-0237, FRM-0238 and FRM-0255) in accordance with these procedural changes; the updated documents will be available on HC’s MedEffect website on October 3rd.
In the meantime, manufacturers and importers should continue submitting MPRs to the Health Products and Food Branch Inspectorate. For questions regarding the procedural change, firms should contact the Canada Vigilance program via email (canadavigilance@hc-sc.gc.ca) or phone (613.957.0337).
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
