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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Jul 9, 2018
EU MDR/IVDR
Although the European Medical Devices Regulation (MDR) will not go into full effect until 2022, if your medical device company does business in the European Union, you may need to modify your labeling before then. The EU MDR has laid out requirements that further...
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Jan 19, 2016
Asia
The Chinese Food and Drug Administration (CFDA) has issued a new “Medical Equipment Generic Naming Guide,” which will be implemented on April 1, 2016. This is the first regulatory document for ‘naming’ generic medical devices. The CFDA believes...
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Sep 17, 2015
South America
Here are steps for proper device labeling in Brazil: The Brazilian Consumer protection code requires that product labeling should provide the consumer with accurate, concise and easily readable information. about the product’s quality, quantity, composition,...
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