Australia – Australian regulators plans up-classification of medical devices targeting circulatory, nervous systems

The Australian Therapeutic Goods Administration (TGA) has issued new guidance on plans to reclassify medical devices involved in circulatory and nervous systems from Class IIa (moderate risk) to Class III (high risk).

According to the TGA guidance, the following devices will be reclassified to Class III beginning November 25, 2021:

  • Devices in direct contact with the heart and central circulatory system (CCS), and intended for short-term or transient use
  • Devices in direct contact with the central nervous system (CNS), and intended for transient use…