Australia - TGA Planning a Classification of Medical Devices for The Circulatory and Nervous System

ARQon
Dec 17, 2021
2 min read

The Australian Therapeutic Goods Administration (TGA) has published a new guidance on plans to reclassify medical devices for the circulatory and nervous systems from Class II (moderate risk) to Class III (high risk). According to the guidance document, the reclassification for the following devices will begin on 25 November 2021:

Devices intended for short-term or transient use that come into direct contact with the heart and central circulatory system (CCS)
Devices intended for transient use that come into direct contact with the central nervous system (CNS)

Several devices are included in the TGA guidance as being affected by the reclassification. Cardiac vent catheters, central venous catheterization kits, and cardiopulmonary cannulae will be up-classified devices having CCS applications. Flexible fiberoptic neuroscopes, stiff neuroscopes, and spinal needles are among the affected devices targeting the CNS. TGA timeline for reclassification compliance Compliance deadlines for sponsors of affected devices will depends on their current registration status despite the enforcement date in late November 2021.

Sponsors of devices listed in the Australian Register of Therapeutic Goods (ARTG) before November 25, 2021 must notify the TGA of the necessity to reclassify their listings by May 25, 2022. Before November 1, 2024, these sponsors should submit applications to the ARTG to have their devices listed as Class III.
Sponsors who applied for Class IIa device inclusion in the ARTG before November 25, 2021 should notify the TGA that their listings will need to be reclassified to Class III either before May 25, 2022 or within two months of the start dates of their ARTG entries, whichever comes first. Finally, before November 1, 2024, these sponsors should apply for ARTG Class III device listings.
Sponsors who have not applied for device listing in the ARTG by November 25, 2021 should do so now.

Sources:

Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems