Dec 26, 2020
MHRA
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance dedicated to the custom-made medical devices and applicable regulatory framework. The scope of the document covers all custom-made medical devices, including the active...
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Dec 26, 2020
Asia
The Philippines Food and Drug Administration (FDA) has published a circular implementing the interim guidelines describing the conduct of licensing inspections for radiation facilities. In the case of any discrepancies, the provisions of the new circular shall...
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Dec 26, 2020
MHRA
The Medicines and Healthcare products Regulating Agency (MHRA) of the UK has updated its guidance for medical device manufacturers initially published in December 2014. In particular, the document provides additional clarifications and recommendations regarding how...
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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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