Jan 17, 2019
South America
In Brazil, the institution that oversees medical device regulations is the Brazilian National Health Surveillance Agency (ANVISA). The beginning of the medical device registration process requires the classification of the device according to the level of risk it...
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Oct 8, 2018
South America
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...
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Jan 10, 2018
South America
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...
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Dec 12, 2017
South America
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...
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Jun 15, 2017
Brazil
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...
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