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