South America


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" .





Countries like:



introduced similar regulations with individual national deviations.

If you need further information please don#t hesitate to contact us