Apr 7, 2021
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the eCopy Program for medical device submission. The present document constitutes an updated version of...
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Dec 11, 2019
EU MDR/IVDR
The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit. A General Overview of the Brexit Consequences It is important to...
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Dec 10, 2019
Saudi Arabia
Saudi Arabia`s Food and Drug Authority (SFDA) announced the launch of an entirely new online platform for medical device manufacturers to file all submissions related to medical devices. New Online Platform According to the information provided in the...
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