Mar 2, 2023
Europe
The new article highlights the aspects related to the classification of medical devices the UK authority intends to improve by the virtue of amending the existing regulatory framework. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA),...
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Jan 23, 2023
Europe
The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used. Table of Contents The UK Medicines &...
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Jan 16, 2023
Brazil
The new article addresses the aspects related to the regulatory requirements to be applied with respect to the software products intended to be used for various purposes, including diagnosing and interaction with laboratory equipment. Table of Contents The Brazilian...
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Aug 26, 2021
Asia
The Health Sciences Authority, Singapore’s agency in the sphere of medical devices, announced public consultations on the risk classification of Standalone Medical Mobile Applications (SaMD) and qualification of Clinical Decision Support Software (CDSS). The present...
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Aug 11, 2021
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has initiated a public consultation on the risk classification of standalone medical mobile applications (SaMD) and qualification of clinical decision support...
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