Oct 4, 2022
Australia and Oceania
The new article describes the aspects related to safety considerations for medical devices used in MR environments. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a...
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Sep 28, 2022
Australia and Oceania
The new article provides additional clarifications regarding the way two medical devices could be compared for the clinical evidence to be used in a new marketing application. Table of Contents The Therapeutic Goods Authority (TGA), an Australian regulatory agency in...
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Sep 23, 2022
Australia and Oceania
The new article describes in detail the approach to be applied concerning comparable devices including substantially equivalent devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
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Sep 23, 2022
Australia and Oceania
The present article provides a brief overview of the regulatory matters related to the clinical evaluation reports to be submitted by the parties responsible for clinical trials. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating...
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Aug 31, 2022
FDA
The new article addresses the aspects related to warnings and precautions to be included in medical device patient labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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