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pupsit

Pre-use Post Sterilisation Integrity Testing – PUPSIT

What is Pre-use Post Sterilisation Integrity Testing (PUPSIT)?
PUPSIT stands for pre-use post sterilisation integrity testing. PUPSIT is performed once your sterilising filter is installed to ensure that the sterilisation and installation process has not …

medical-device-regulation-mdr

Medical Device Regulation (MDR) – 11 Key Changes

The EU Medical Device Regulation (MDR) is the most significant regulatory change in Europe in over 20 years. The MDR will replace the Medical Device Directive 93/42/EEC, effective 26th May 2020. The MDR entered …

exporting-medicinal-cannabis

Exporting Medicinal Cannabis from Australia to Germany

With the legalisation of cultivation and export of medicinal cannabis products within Australia, many growers and companies producing medicinal cannabis products have set their interest in exporting their excess products to other parts of …

software-as-a-medical-device

Software as a Medical Device (SaMD)

SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is …

Hands with cream

CBD cosmetics – a cautionary tale

Unlike other markets (i.e. Canada, the US, the UK and parts of Europe) CBD is more strictly controlled in Australia, and the pure extracts (as well as any associated products) are considered Schedule 4 …