Regulatory News

Australia TGA Publishes Guidance Document on Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems

Therapeutic Goods Administration (TGA) Australia has published a guidance document on the reclassification of medical devices in direct contact with the heart, central circulatory system (CCS) and central nervous system (CNS) in August 2021.  
The guidance document aims to assist sponsors of medical devices intended to