The Therapeutic Goods Administration (TGA) Australia has published a set of frequently asked questions (FAQs) on reclassification of medical devices in November 2021.
One of the most important points to note is the identification of medical devices that will undergo reclassification from 25 November 2021. Some of the devices are active medical devices for therapy with a diagnostic function, spinal implants for motion preservation, and devices in direct contact with the heart, central circulatory system, central nervous system.
There is also a requirement to notify TGA if any registered device is being reclassified. This will ease the transitional process and will allow registrants to continue supplying the medical devices at the existing classification, while waiting for the reclassification to be valid. TGA will need to be notified by COB 24 May 2022 and if this step is not completed, the supply of the device will have to be discontinued from 25 May 2022.
More details can be found in “Frequently asked questions (FAQs) on reclassification of medical devices, November 2021”: https://www.tga.gov.au/frequently-asked-questions-faqs-reclassification-medical-devices