![SAHPRA on MD/IVD classification (invasive devices)](https://www.regdesk.co/wp-content/uploads/2023/06/1-SAHPRA-Guidance-on-MD_IVD-Classification_-Invasive-Medical-Devices.png)
Jun 20, 2023
Africa
The new article highlights the aspects related to the classification rules to be applied with respect to invasive medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s agency responsible for ensuring the safety...
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![SAHPRA on MD/IVD classification (active medical devices)](https://www.regdesk.co/wp-content/uploads/2023/06/1-SAHPRA-Guidance-on-MD_IVD-Classification_-Active-Medical-Devices.png)
Jun 20, 2023
Africa
The new article highlights the aspects related to be taken into consideration with respect to the classification of active medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s regulatory agency in the sphere...
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![Swissmedic on IVD performance trials (safety and AE reporting)](https://www.regdesk.co/wp-content/uploads/2023/06/1-Swissmedic-Guidance-on-IVD-Performance-Trials_-Safety-Matters-and-Adverse-Events-Reporting.png)
Jun 15, 2023
Europe
The new article highlights the aspects related to the safety measures to be introduced by study sponsors, as well as the way adverse events associated with a medical device in question should be reported to the authority. Table of Contents The Swiss regulating...
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![Swissmedic Guidance on IVD Performance Trials: Modifications](https://www.regdesk.co/wp-content/uploads/2023/05/1-Swissmedic-Guidance-on-IVD-Performance-Trials_-Modifications.png)
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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![Swissmedic Guidance on IVD Performance Trials: Surveillance and Reporting](https://www.regdesk.co/wp-content/uploads/2023/05/1-Swissmedic-Guidance-on-IVD-Performance-Trials-Surveillance-and-Reporting.png)
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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