The Russian Federation issued several regulations implementing additional measures to ensure and expand the availability of medical devices that are vitally important during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the...
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...
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...
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...
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...