BfArM
The article addresses the aspects related to the fees payable by the interested parties and also provides definitions of the most important terms and concepts.
CHMP
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products.
FDA
The article highlights the key points related to notification requirements medical device manufacturers should follow with respect to possible discontinuance or interruption in the manufacturing process.
FDA
The article describes in detail the approach to be applied for credibility factors and credibility goals to be considered by the parties responsible for medical devices.
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.
FDA
The new article highlights the aspects related to specific categories of credibility evidence the authority will expect medical device manufacturers to collect to demonstrate compliance with the relevant regulatory requirements, as well as the safety and proper performance of their products in general.
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