The Medical Devices Vigilance Program (MDVP) is an initiative to improve sponsors' understanding of, and compliance with, their post-market vigilance regulatory requirements, through a self-assessment tool and program of desktop audits and on-site inspections.
The MDVP was developed following the 2020 Therapeutic Goods Administration (TGA) consultation: 'Proposed enhancements to adverse event reporting for medical devices'. Feedback from the consultation indicated support for Proposal 3 (Implement TGA audits of sponsor activities and premises to validate how they conduct post-market surveillance obligations), the need to reinforce the requirement to hold timely and accurate information, and education to promote better regulatory compliance among medical device sponsors.
The MDVP will complement our existing post-market monitoring, review and audit activities for medical devices. It is expected that with more informed sponsors, patient safety will improve through better and more timely reporting of adverse events to the TGA.
Presenters
Maria Ong, Director, Medical Devices Surveillance Branch, TGA
