Jan 6, 2020
South America
The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s regulating authority in the sphere of medical device circulation, has recently issued the updated rules regarding the registration of medical devices. The most important amendments...
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Dec 16, 2019
Europe
The Medical Device Coordination Group (MDCG), the advisory body that consults the European Commission on the implementation of laws surrounding medical device circulation, issued guidance related to a new codification system to be used under the framework established...
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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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Nov 8, 2019
North America
The Food and Drug Administration (FDA) has published a document amending the list of consensus standards utilized in the review of premarket submissions. Voluntary Consensus Standards Recognized by FDA The 1997 Food and Drug Modernization Act introduced the...
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