Jan 27, 2023
Australia and Oceania
The new article provides an overview of the recent changes to the classification rules for active implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...
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Dec 1, 2022
Malaysia
The new article describes in detail the aspects related to the roles and responsibilities of the entities engaged in operations with medical devices. Table of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices,...
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Nov 30, 2022
Australia and Oceania
The new article provides additional details regarding the applicable regulatory requirements for the content and format of interim and final post-approval study reports. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Nov 30, 2022
Australia and Oceania
The new article highlights certain specific aspects related to clinical outcome studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
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Nov 30, 2022
Australia and Oceania
The new article describes in detail the approach to be followed with respect to the aspects related to the preparation and submission of the reports on post-approval studies, including the general information about the types of reports and submission timelines. Table...
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