Day 27 July 2021

EMA adopts guideline on quality documentation for medicinal products when used with a medical device

The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…

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TGA publishes guidance for developers and users of software to decide which software and apps are medical devices

The TGA, Australia has published guidance for developers and users of software to decide which software and apps are medical devices. The flowcharts in the guidance document show which software products are regulated as a medical device and which are…

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