North America
On March 15, 2019, the US Food and Drug Administration (FDA) issued a final guidance document on medical devices using materials derived from animals. This documents intends to help manufacturers establish relevant procedures to lower the overall risk of infection...
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
South America
Brazil is the largest medical device market in Latin America, and has an established but complex regulatory system. Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). ANVISA in its effort to streamline medical device...
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