Source: Australian Therapeutic Goods Administration
This webinar aims to provide targeted information to medical devices consumers about the proposed enhancements to adverse event reporting.
In the first half of this webinar, four proposals of the consultation paper will be summarised, followed by a question and answer session for the participants to raise their individual queries. This webinar will equip and enable the participants in providing feedback to the consultation on enhancing medical device adverse event reporting.
A succession of reviews, parliamentary inquiries, international and national media interest, and stakeholder feedback has raised concerns about the post market safety, and regulatory monitoring and vigilance process of medical devices. While Australian regulatory practices are comparable to other regulators around the world, this consultation seeks feedback on proposals to strengthen them further. Improving Australia’s adverse event reporting system will allow the TGA to take quicker actions where there are safety concerns.
- Proposed change to exemption rules: Currently there are eight exemption rules, consistent with other comparable countries that may exempt sponsors from reporting an adverse event to the TGA. These exemptions might be one of the reasons for lower than expected adverse event reporting. The proposal looks to removing or amending these exemption rules.
- Proposed timeframe to submit final reports: Medical devices sponsors and manufacturers are required to report adverse events within mandatory timeframes depending on the severity of the incident. An initial report with all the available information may be submitted within this timeframe followed by providing further information as it becomes available through a final report. Whilst the legislation provides timeframe for an initial report, it does not include a mandated timeframe to submit the final adverse event report. The proposal looks at introducing a timeframe for final reports.
- Proposed changes to definitions: The European Union (EU) Regulation on Medical Devices (2017/745) introduced several amended post-market related definitions that will be adopted in each of member states/European countries legislative instruments. The Australian legislation does not include direct definitions to these words/terminology. The proposal looks to which, if any, of these definitions would be beneficial to be included in the Australian legislation.
- Suggestions for making information better for consumers: Consumer groups’ feedback has confirmed that most of the consumers either do not know the role of TGA or find it difficult to navigate and understand the medical devices related information provided. The proposal looks at reviewing the accessibility and usefulness of the information provided by the TGA.
Who should attend?
Any interested medical device consumers such as patients, family members of patients, healthcare facilities, and health care professionals who may be directly/indirectly affected by changes to current processes.
When will the webinar take place?
- Monday 26 October 2020, 2:00-2:45pm
- Please register here to attend the webinar