Aug 13, 2022
Africa
The new article provides additional details regarding un-permissible changes to medical devices as set forth under the applicable legislation and also outlines the key points related to the change type assessment decision trees. Table of Contents The Tanzania...
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Aug 9, 2022
Africa
The new article provides additional details regarding the types of changes to medical devices, their features, and the regulatory approach to be applied. Table of Contents Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the...
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Aug 7, 2022
Africa
The article provides an overview of the regulatory requirements related to changes to medical devices already placed on the market. Table of Contents The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere of...
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Jul 3, 2022
Africa
The new article explains the three steps testing approaches and highlights the key points associated thereto. The document also addresses the aspects related to documentation and reporting. Table of Contents The Pharmacy and...
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Jun 27, 2022
Africa
The new article provides additional clarifications regarding certain specific aspects related to post-market surveillance, including the activities to be undertaken by the parties involved to ensure continuous safety and proper performance of medical devices placed on...
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