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The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
Medical Devices
