The Therapeutic Goods Administration (TGA) Australia has announced an update on another medical device reform, which is the reclassification of certain medical devices, in November 2021.
The reclassification of certain medical devices came into effect on 25 November 2021. The TGA must be notified by 25 May 2022 if there is an inclusion that needs to be reclassified, to ensure the continuous supply of the device. However, sponsors of Class IIb spinal fusion implantable devices would have needed to notify the TGA by 27 October 2021.
Submission of medical device inclusions’ applications on or after 25 November 2021 must be done according to the new classification rules.
Some of the examples of the reforms that has taken place are the reclassification of active medical devices for therapy with diagnostic function from Class IIa or IIb to Class III. Devices used in direct contact with the heart, central circulatory system (CCS), or central nervous system have been re-classified from Class IIa to Class III.
More details can be found in “Medical devices reforms: Reclassification of certain medical devices, November 2021”: https://www.tga.gov.au/medical-devices-reforms-reclassification-certain-medical-devices