Australia's Therapeutic Goods Administration (TGA) proposed classifying active implantable medical devices (AIMDs), their accessories and active devices for controlling, monitoring or influencing the performance of an active device and software as high-risk class III devices. However, the agency has rethought the notion of up-classifying all implant device accessories after blowback from industry.

PERTH, Australia – Melbourne-headquartered regenerative medicine company Avita Medical Ltd. raised AU$120 million (US$81 million) in an institutional placement that will fund pipeline development of new indications for its Recell spray-on-skin treatment and expand its commercial footprint in the U.S. and Japan.

Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.

MELBOURNE, Australia – Although Australia was one of the first movers in the regenerative medicine space, until now a cohesive plan for investing in regenerative medicine was holding the sector back.

PERTH, Australia – Although medical device industry stakeholders agreed in principle with the Australian Therapeutic Goods Administration's (TGA) proposal to align its classification with the EU's for implantable spinal devices, they viewed the interpretation of the EU Medical Device Regulation (MDR) classification rule for these devices differently.

Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies.