Updates to the Guidance Document for Mandatory Problem Reporting for Medical Devices and the Mandatory Medical Device Problem Reporting Form for Industry

October 25, 2011

Notice

11-119782-980

In an effort to provide clarification to manufacturers and importers of medical devices, the Canada Vigilance - Medical Device Problem Reporting Program would like to provide a summary of the updates that have been made to the Guidance Document for Mandatory Problem Reporting for Medical Devices and the Mandatory Medical Device Problem Reporting Form for Industry.

The Guidance Document for Mandatory Problem Reporting for Medical Devices supersedes the previous version of the guidance document (January 2011), titled Guidance Document for Mandatory Problem Reporting for Medical Devices (GUI-0059). In addition to the changes in the formatting, the guidance document has the following minor changes:

• Clarification of the reporting requirements for radiation emitting devices (section 2.2), including the definition of the radiation emitting device (section 1.4).
• The addition of device license number in the information required to be submitted in the preliminary report (section 2.10.1.1).
• Information on how the Canada Vigilance - Medical Device Problem Reporting Program will address inadequacies in reporting (section 2.11).
• The updated postal address provided for submitting mandatory problem reports to Health Canada (section 2.13).
• Additional request for the reporter file number to be included on any additional correspondences relating to the same report (section 2.13).

The Mandatory Medical Device Problem Reporting Form for Industry, has been formatted to include all information outlined for the submission of preliminary, updates, finals, or preliminary and final reports in a single consolidated form. The information has been incorporated into a new template, with the addition of definitions to provide guidance on each section of the form. The new form is available as a fillable PDF document, and can be saved and stored. Additions to the form include:

• Addition of section (B1 iii) identifies medical devices that are used in investigational testing, through special access program or are radiation emitting devices.
• Addition of a section for Patient consequences (B4) which includes details on the consequences (or potential consequences) to the patient, user or other person(s) involved in the incident.
• Addition of a section indicating the Device Identification No. (C4 iii) assigned by Health Canada on issuance of a device license.

Should you have any questions regarding this guidance document, please contact the Canada Vigilance - Medical Device Problem Reporting Program.