May 11, 2022
Africa
The new article describes in detail the responsibilities of the parties involved in operations with medical devices in terms of post-marketing surveillance. Table of Contents The Ministry of Health of Kenya has published a guidance...
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May 1, 2022
Africa
The article provides an overview of the Kenyan regulatory requirements in the sphere of post-market surveillance for healthcare products. Table of Contents The Pharmacy and Poison Board, a division of the Kenyan Ministry of Health,...
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Jun 2, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published draft guidance describing the suggested approach for postmarket surveillance to be performed under Section 522 of the Federal Food, Drug,...
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