Brazil ANVISA drug regulatory body, announced Wednesday at the RAPS’ Regulatory Convergence that more than 800 new and generic drug application backlogs would be eliminated by January 2019. This elimination would allow for a shift in focus on new projects that ANVISA...
The National Health Surveillance Agency of Brazil, ANVISA, has proposed a new guideline for importation of products subject to sanitary surveillance. This effort has been made to ease importation burden and increase speed to market. ANVISA issues three hundred...
ANVISA recently introduced a new requirement for medical device manufacturers who will be conducting clinical investigations. Sponsors will need to submit Medical Device Clinical Dossier clinical (DICD). This resolution will be applicable to all clinical trials with...
You probably have experienced frustration related to the rejection of your product application in some country. Perhaps you’re experiencing it now. Basically, if you need Brazil medical device registration, you will need ours help. Here is how one company...
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...