Day 18 May 2021

COVID-19, Medical Devices, Medical Devices Coordination Group

MDCG notice on the impact of genetic variants on SARS-COV-2 IVD medical devices

The European Medical Devices and Coordination Group (MDCG) has endorsed a notice on the impact of genetic variants on SARS-COV-2 IVD medical devices. The notice (MDCG 2021-7) is addressed to manufacturers and authorised representatives of in vitro diagnostic medical devices (IVDs) with…

18 May 2021

Good Manufacturing Practice, TGA (Australia)

TGA guidance on GMP compliance requirements and framework for managing compliance signals

The TGA, Australia has issued guidance on GMP compliance requirements and framework for managing GMP compliance signals. The 17 page guidance document outlines: the Good Manufacturing Practice (GMP) compliance requirements according to the Manufacturing Principles for manufacturing biologicals and medicines…

18 May 2021

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