Description
Ensuring compliance with medical device vigilance reporting in Canada is essential for maintaining Health Canada approval and ensuring patient safety. Under the Medical Devices Regulations (SOR/98-282), manufacturers, importers, and healthcare facilities are legally required to report adverse events, serious incidents, and potential safety concerns through Mandatory Problem Reporting (MPR). Failure to comply can lead to regulatory enforcement actions, product recalls, or suspension of medical device licenses (MDL & MDEL).
SOP-REG-008: Medical Device Vigilance Reporting in Canada provides a structured, step-by-step framework for manufacturers, importers, and healthcare institutions to meet Health Canada’s post-market surveillance and adverse event reporting obligations. This SOP ensures full compliance with ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and Canadian post-market surveillance (PMS) regulations, enabling businesses to reduce compliance risks, streamline reporting processes, and maintain long-term regulatory approval.
Compliance with Health Canada’s post-market surveillance (PMS) and Mandatory Problem Reporting (MPR) requirements is legally required for all medical device manufacturers, importers, and license holders in Canada. Medical Devices Regulations (SOR/98-282) mandates that companies systematically track, assess, and report device malfunctions, adverse events, and serious incidents within strict timelines. Non-compliance can lead to license revocation, regulatory penalties, or product recalls.
SOP-REG-008: Medical Device Vigilance Reporting in Canada provides a clear, structured approach to:
🔹 Determine if an adverse event, serious injury, or device malfunction is reportable under Canadian law.
🔹 Ensure accurate and timely submission of adverse event reports through Health Canada’s online reporting system.
🔹 Comply with post-market surveillance (PMS) and risk management requirements.
🔹 Streamline regulatory reporting and reduce compliance burdens for manufacturers and importers.
🔹 Align vigilance activities with ISO 13485:2016 and MDSAP for seamless global regulatory compliance.
This SOP is essential for Medical Device Manufacturers, Regulatory Affairs Professionals, Importers, Distributors, Healthcare Facilities, and Consultants seeking a cost-effective, structured approach to medical device vigilance reporting in Canada.
With SOP-REG-008, your business can eliminate reporting delays, avoid regulatory penalties, and enhance patient safety while maintaining full Health Canada compliance.
