Australia Proposes New Device Classifications to Align With EU Regs
Australia’s TGA released five new draft guidances that propose changes to the classification of numerous medical devices to align more closely with European Union regulations.
The guidances consider the EU’s Medical Device Regulation and the potential impact on Australia’s regulatory requirements. The five guidances propose changes in device classification for active implantable devices and their accessories, medical devices that administer medicines or biologicals by inhalation and other products.
Australia currently has a separate category for active implantable medical devices, called Class AIMD and the agency proposes to classify these as Class III devices, which would simplify the TGA classification scheme.