MDSAP Audit Approach (MDSAP AU P0002) C3-T12-CA: For Canada, keep problem and complaint records, run effective investigation and recall procedures, prepare periodic summary reports with critical benefit-risk analysis and notify the Minister within 72 hours of a changed benefit-risk conclusion

What does C3-T12-CA require?

Manufacturers must record reported problems with device performance or safety, including consumer complaints received after first sale in Canada, and the actions taken (CMDR 57), and have documented procedures for effective, timely investigation of problem reports and recalls (CMDR 58). They must prepare summary reports covering the prior two years for Class II devices and the prior year for Class III and IV devices, addressing adverse effects, problems and complaints received, reportable incidents and serious risks of injury, with a concise critical analysis and conclusions on whether benefits could be less, risks more likely or more serious, or new risks identified (CMDR 61.4); write to the Minister within 72 hours of concluding that what is known about benefits and risks has changed; and keep summary reports, underlying information and notifications for seven years (CMDR 61.6).