Mar 16, 2021
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published updated guidance on in vitro diagnostic (IVD) medical devices intended for point of care use. The initial version of the...
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Dec 15, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published a guidance document describing the priority applicant determination criteria and process for all types of medical devices including the ones intended for in vitro diagnostics (IVDs). The present...
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Nov 16, 2020
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework for medical devices, has published guidance on classification rules for in vitro diagnostic medical devices (IVDs). The...
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Sep 17, 2020
COVID-19
The Saudi Food & Drug Authority (SFDA), the regulating authority in the sphere of medical devices in Saudi Arabia, has published a guidance document dedicated to the requirements for unique device identification (UDI) for medical devices. The present document...
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Sep 16, 2020
COVID-19
The Ministry of Healthcare of Peru has adopted a special regulation dedicated to the in vitro diagnostic (IVD) tests intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the «novel coronavirus». For this...
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