New TGA guidlines for RATs, page-2

Thanks Randomguy , a very insightful read , I can understand the frustration by management , the TGA can keep adding additional conditions on a case by case basis if they see fit, you cannot blame management for this delay , these TGA guys have been moving the goal post since Anteotech lodged the application back in September and will continue doing so according to these guidelines, do the same standards apply to the labs & PCR ? these hurdles if applied will see very few RATS approved , could be very good for Anteotech being the designer and the manufacture of such a highly sensitive test and near impossible for sponsors of "average" imported tests ensuring I guess 95 % of RATS fail to make the grade, Federal and state governments supporting RATS need to be made aware of this supply road block by the TGA of excellent Australian made RATS ! lets see how many currently TGA approved tests get pulled by the TGA?

Additional conditions may be applied Depending on the performance of the test, the information provided in the IFU and robustness of the test, the TGA may impose additional non-standard conditions to mitigate any residual risk identified relating to the effective and safe use of the product or to facilitate the monitoring of potential trends. These are likely to include a requirement that the sponsor:

• provide additional support for users of the test through provision of information that will direct users to on-line support services that consists of either a helpline or on-line interactive support service.
• provide on their web-site instructional videos or on-line simple graphical instructions in the correct use and performance of the device.
• provide to the TGA an electronic copy of the IFU to be displayed on the TGA website. Upon release of a new version of the IFU by the manufacturer, the sponsor must provide this to the TGA, within 3 busines days for display on the TGA website.
• submits to the TGA through the medical device Incident Reporting and Investigation Scheme (IRIS) all complaints (including adverse events) related to the use of performance of the device, as soon as they are received by the sponsor, for the next five (5) financial years. This includes but is not limited to adverse events and reports of false positive and false negative results.
• provide the TGA with regular post market surveillance reports for each reporting period commencing on the date of inclusion of the device in the ARTG and ending at the end of each month until 30 June 2022. Until 30 June 2022, reporting periods are on the final day of each month, with the report to be submitted no later than the final day of the following month. Following July 1, 2022, and each twelve (12) months thereafter for the next three (3) financial years. Reports must be provided to the TGA before 1 October after each reporting period.
• include in the post market surveillance reports information on the distribution of the product, numbers of tests sold and numbers of any adverse events including reported false positive or false negative results and problems with poor performance of the test in Australia and worldwide.
• provide the post-market reports to the TGA at the following email address,

[email protected]. Any further conditions would be applied on a case-by-case basis and would depend on the evaluation of an individual product, the overall benefits, and how well any risks have been mitigated. The most up to date conditions for rapid antigen tests are published on the TGA website:

• Conditions specific to COVID-19 rapid antigen self-tests
• Conditions specific to COVID-19 rapid antigen point-of-care tests Post-market review The TGA can conduct a post-market review of certain kinds of devices included in the ARTG. ARTG entries for COVID-19 rapid antigen self-tests will be subject to a post-market review. Sponsors will be required to provide evidence of the performance of their device with respect to the variants of concern, as well as their risk management plans to ensure continued performance with the emergence of new variants. In addition, sponsors may be asked to provide test kits for independent laboratory evaluation of the clinical sensitivity and specificity to verify their performance.