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:

 

 

Brazil

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" .

 

Argentina

 

 

Countries like:

Argentina

Columbia

introduced similar regulations with individual national deviations.

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