Mercosur, the economic and the political agreement between Latin American countries should have simplified commercial regulations and activities between those counties.  As of 2010, Mercosur includes: Argentina, Brazil, Paraguay and Uruguay, Bolivia, Chile, Colombia, Ecuador and Peru.  All these countries currently have an associate member status and Venezuela is a potential member. 

Brazil, being one of the most dominant markets in this territory and also the only non-Spanish speaking country in Latin America has integrated quality assurance inspection requirements that make the registration process one of the longest and the most expensive in Latin America.

In Latin America, countries vary according to the level of regulatory requirements they impose on both the local manufacturers and the imported medical products.  Some follow the major principals of either the USA or the EU while others have integrated further requirements within their legislations.

The common denominator is the requirement of having a local representative to complete the registration process.  Foreign companies should consider appointing a local representative rather than a commercial distributor.

Please note: Mexico is covered in North America territory section of our website.