Jun 12, 2023
Europe
The new article highlights the aspects related to modifications to performance studies. In particular, the authority describes the approach to be applied when determining the regulatory status of modifications, as well as subsequent procedures to be followed by study...
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Jun 12, 2023
Europe
The new article addresses the aspects related to surveillance activities to be carried out by the authority, as well as the applicable reporting requirements the parties responsible for performance investigations should follow. Table of Contents The Swiss regulating...
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Jun 12, 2023
Europe
The new article highlights the aspects related to the review of the application by the authority and regulatory decisions the authority may take based on the results of such a review. Table of Contents The Swiss regulatory agency in the sphere of healthcare products,...
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Jun 12, 2023
Australia and Oceania
The article provides an overview of the existing regulatory framework for software-based medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in healthcare products, has published guidelines on the...
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Jun 12, 2023
Europe
The new document describes in detail the aspects related to the existing types of clinical trials, as well as the way an interested party should submit an application. Table of Contents Switzerland’s regulating authority in the sphere of healthcare products,...
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