Sep 18, 2020
Brazil
Anvisa, the Brazilian national healthcare authority, has published a regulation dedicated to the software with the intended medical purpose. Purposes of the New Brazilian SaMD Regulation The document outlines the main regulatory issue to be solved by the legislative...
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The National Health Surveillance Agency (ANVISA), the Brazilian medical device regulating authority, announced the implementation of the special regulatory framework related to additional measures to be introduced to address issues related to the outbreak of the...
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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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