Description
Ensuring compliance with medical device vigilance reporting in Australia is critical for maintaining Therapeutic Goods Administration (TGA) approval and ensuring patient safety. Under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, manufacturers and sponsors must report adverse events, device malfunctions, and safety concerns as part of their post-market surveillance (PMS) obligations. Failure to comply can result in regulatory enforcement actions, recalls, or suspension of Australian Register of Therapeutic Goods (ARTG) inclusion.
SOP-REG-009: Medical Device Vigilance Reporting in Australia provides a structured, step-by-step framework to help manufacturers, sponsors, and distributors meet TGA’s post-market compliance requirements. This SOP ensures adherence to ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and Australian vigilance reporting guidelines, allowing businesses to mitigate regulatory risks, streamline reporting processes, and maintain market authorization.
Compliance with TGA’s post-market surveillance (PMS) and medical device vigilance regulations is mandatory for all manufacturers, sponsors, and ARTG certificate holders operating in Australia. The Therapeutic Goods Act 1989requires companies to systematically track, assess, and report device malfunctions, adverse events, and product complaints. Non-compliance can lead to product recalls, regulatory warnings, financial penalties, or market removal.
SOP-REG-009: Medical Device Vigilance Reporting in Australia provides a clear, structured approach to:
🔹 Determine whether an adverse event, serious injury, or device malfunction requires reporting to TGA.
🔹 Ensure timely submission of reports for adverse events, recalls, and safety concerns.
🔹 Comply with TGA’s post-market surveillance and adverse event reporting guidelines.
🔹 Establish internal processes for complaint handling and risk assessment.
🔹 Align vigilance reporting with ISO 13485:2016 and MDSAP for streamlined global compliance.
This SOP is essential for Medical Device Manufacturers, Regulatory Affairs Professionals, Sponsors, Importers, Distributors, and Consultants looking for a cost-effective, structured approach to medical device vigilance reporting in Australia.
With SOP-REG-009, your business can ensure full compliance with TGA requirements, minimize regulatory risk, and maintain ARTG approval while enhancing patient safety.
