TGA Medicinal Cannabis
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TGA Medicinal Cannabis

I’m often asked to clarify the difference between TGA Medicinal Cannabis and EU GMP Medicinal Cannabis, i.e. who is that has the highest “Gold Standard” for Medicinal Cannabis? I suspect this has come about because many are trying to claim that their cannabis is cultivated, harvested and processed in accordance with the strictest pharmaceutical standards…

Brexit and Medical Devices Regulation in the United Kingdom
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Brexit and Medical Devices Regulation in the United Kingdom

On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union. What does this mean for Australian based medical device manufacturers wishing to place their device on the UK…

Custom-Made Medical Devices | Changes – February 25, 2021

Custom-Made Medical Devices | Changes – February 25, 2021

Personalised medical devices cover a range of products. Custom-made medical devices are medical devices designed and made as specified by a health professional to be used by a specific individual. They are not to be confused with mass-produced off-the-shelf devices that are customised, adapted or modified after supply, also known as adaptable medical devices. Custom-made…