ABSTRACT
The international medical device industry has been set in the region, bringing an increase of active medical device companies in Latin America's territory. MERCOSUR also provides medical devices guidance to the state's political party, it means, the technical regulation mercosur 40/00, which adopts elements from the US, Canadian and European Union regulatory systems, has a high influence in the medical regulation in the region where it is effective. Although Argentina and Brazil share the same mercosur directive for medical devices, each country has its own particularity for additional requirements in terms of medical device registration. The certification must be held by a Brazilian entity, which should be the same entity that is appointed as license holder. The medical device post-market is very significant in Brazil although there is no regulation in place or requirements of post-market studies as an approval condition but the process can be delayed if Agencia Nacional de Vigilancia Sanitaria requires additional information.
