TGA regulations

Electronics

Transition Plan and Regulatory Changes for Software as Medical Devices

In our November 2020 blog post, we communicated the changes regarding the implementation dates and the criteria for Software as a Medical Device regulations as amended in the Therapeutic Goods...
3D Printing of Hand

Transition plan from Custom device to Patient-matched

In our Blog of June 2020, we communicated on the delays relating to the implementation dates of the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002. The...
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What you need to know about disinfectants in Australia

In May 2020, we looked at hand sanitisers and TGA’s exemption on certain formations in response to the COVID-19 emergency. As we are seeing an increasing number of corporations receiving...

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