May 24, 2023
FDA
The new article addresses the aspects related to the way the need in a new marketing submission should be determined and to the implementation of modifications. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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Aug 5, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the integration of the UDI within organizations’ quality management systems. The MDCG...
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Aug 3, 2021
Asia
The Health Sciences Authority (HSA), Singapore’s agency responsible for regulations in the sphere of healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. Table of Contents Apart from the...
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Jul 17, 2020
Europe
Swissmedic, the Swiss agency for therapeutic products, announced the implementation of a new technical standard to be used when submitting a marketing authorization application for a medicinal product. The present document constitutes an improved version of the...
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Jun 24, 2020
Australia and Oceania
In relation to difficulties associated with the Coronavirus or COVID-19, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain...
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