Aug 14, 2023
Australia and Oceania
The new article provides an overview of the applicable regulatory procedures and requirements. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document...
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Aug 11, 2023
Europe
The new article highlights aspects related to electronic submissions and specific types of products. Table of Contents The Swiss regulatory authority in the sphere of healthcare products (Swissmedic) has published a guidance document dedicated to the regulatory...
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Aug 10, 2023
Europe
The guidance addresses aspects related to the safety measures to be developed and introduced by the parties responsible for performance trials in order to ensure the safety of study participants while maintaining the accuracy and reliability of the study results....
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Jun 30, 2023
Africa
The new article highlights the aspects related to the classification rules to be applied with respect to in vitro diagnostic medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA) has published a guidance document dedicated...
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Jun 26, 2023
Europe
The new article describes in detail the approach to be applied with respect to notifications, databases, liability insurance, and other aspects related to performance studies involving in vitro diagnostic medical device Table of Contents The Swiss regulating authority...
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