FDA
The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.
SAHPRA
The article highlights the key points related to the licensing regime for medical device establishments.
FDA
The new article highlights the aspects related to the general regulatory framework for computational modelling and simulations used in the healthcare sphere in the context of medical device development.
Malaysia
The new article describes in detail the approach to be applied with respect to applications for advertisement approval to be submitted by interested parties.
SAHPRA
The new article highlights the aspects related to the process of applying for a medical device establishment license required to conduct operations with medical devices.
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