EU
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
Saudi Arabia
The new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.
FDA
The new article highlights the aspects related to the review process itself.
FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to 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.
