TGA Proposes Changing the Classification of Circulatory System Devices
Australia’s Therapeutic Goods Administration (TGA) is proposing to update its classification of central circulatory system devices to align with classifications used by the European Union (EU).
The agency proposes to classify surgically invasive medical devices intended to be used in direct contact with the heart, central circulatory system or the central nervous system as Class III (high-risk), regardless of the duration of use or intended indications.
The TGA noted that Australia’s current definition of the central circulatory system devices dates back to 2002 and that the EU has made several changes to its classifications since then.
The agency is accepting comments on the proposal until Feb. 10.