The South American countries further evolve approval processes for medical devices. MOstly these requirements are based on the harmonized MERCOSUR directives.
The best example is currently:
With the adoption of two decrees and RDC 24 RDC 25 in May 2009 all manufacturers of medical devices and in vitro diagnostics need to go through a regsitration and / or approval procedure.
This may include the certification of the quality management system by the ANVISA or under the new MDSAP auditing system.
More information is available under "Downloads" .
introduced similar regulations with individual national deviations.
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