Latin America consists of the regions of Central and South America and comprises twenty countries. Having the total population of approx. 650 million people LATAM countries make an attractive medical device market. However, regulatory decisions in some Latin American countries are often made on case-by-case basis. Which might hinder putting your medical device on the LATAM markets and which is why deep understanding of the regulations and regulatory processes of your target markets is extremely important. The biggest Latin American markets of medical devices are Brazil, Argentina and Mexico.
Regulatory requirements of the biggest Latin American markets are largely harmonized under the South American trade bloc Mercosur comprising Argentina, Brazil, Paraguay, Uruguay as well as associated countries such as Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Suriname. The largest medical devices Mercosur markets are Brazil and Argentina.
In general, medical device regulatory requirements in Mercosur countries and associated countries are similar but not identical. Sometimes regulatory procedures can vary within the same jurisdiction and regulatory decisions are made on a case by case basis.
Mexico does not belong to Mercosur trade bloc and its regulatory framework (medical device classification, technical documentation, quality system and other regulatory requirements) is substantially different from Brazil’s, Argentina’s and other Mercosur-countries’ regulations. Approval process in Mexico is facilitated if you medical devices already have US FDA or EU approvals.
Latin America consists of the regions of Central and South America and comprises twenty countries. Having the total population of approx. 650 million people LATAM countries make an attractive medical device market. However, regulatory decisions in some Latin American countries are often made on case-by-case basis. Which might hinder putting your medical device on the LATAM markets and which is why deep understanding of the regulations and regulatory processes of your target markets is extremely important. The biggest Latin American markets of medical devices are Brazil, Argentina and Mexico.
Regulatory requirements of the biggest Latin American markets are largely harmonized under the South American trade bloc Mercosur comprising Argentina, Brazil, Paraguay, Uruguay as well as associated countries such as Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Suriname. The largest medical devices Mercosur markets are Brazil and Argentina.
In general, medical device regulatory requirements in Mercosur countries and associated countries are similar but not identical. Sometimes regulatory procedures can vary within the same jurisdiction and regulatory decisions are made on a case by case basis.
Mexico does not belong to Mercosur trade bloc and its regulatory framework (medical device classification, technical documentation, quality system and other regulatory requirements) is substantially different from Brazil’s, Argentina’s and other Mercosur-countries’ regulations. Approval process in Mexico is facilitated if you medical devices already have US FDA or EU approvals.
