Dec 28, 2023
SAHPRA
The new article highlights the aspects related to the costs associated with establishment licenses, and supporting documentation interested parties should submit, and also explains cooperation between different regulating authorities and bodies.
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Dec 28, 2023
BfArM
The new article highlights the aspects related to the timeframes the applicants should follow.
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Dec 20, 2023
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.
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Dec 20, 2023
SAHPRA
The article highlights the key points related to the licensing regime for medical device establishments.
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Dec 20, 2023
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.
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