Total population of Latin American countries is about 650 million people. The biggest LATAM medical device markets are Brazil, Mexico and Argentina.
Population of Mercosur countries is about 295 million inhabitants, 85% of this number being population of Brazil (212.4 million people) and Argentina (45.2 million people).
Mexico that is not a Mercosur member has a population of 130 million inhabitants.
More than 75% of medical devices is imported to LATAM from other countries.
Brazilian medical device market amounts to about 2 billion dollars. In Argentina it is about 700 million dollars and in Mexico - 5 billion dollars.
We have a deep knowledge of the regulatory processes of Latin American countries and help medical device companies get their devices approved by the LATAM regulatory authorities and place them on the LATAM markets
Total population of Latin American countries is about 650 million people. The biggest LATAM medical device markets are Brazil, Mexico and Argentina.
Population of Mercosur countries is about 295 million inhabitants, 85% of this number being population of Brazil (212.4 million people) and Argentina (45.2 million people).
Mexico that is not a Mercosur member has a population of 130 million inhabitants.
More than 75% of medical devices is imported to LATAM from other countries.
Brazilian medical device market amounts to about 2 billion dollars. In Argentina it is about 700 million dollars and in Mexico - 5 billion dollars.
Technical documentation of medical devices in Latin American countries should conform to local standards that often differ from the EU and US regulations. MDRC can prepare technical documentation for your devices that complies with the regulatory requirements of LATAM countries (ANVISA, ANMAT, COFEPRIS and other national agencies).
Foreign medical device manufacturers are obliged to make sure that their authorized representatives in LATAM countries maintain risk management systems compliant with local regulations. MDRC can inspect your authorized representative's risk management system on your behalf.
Medical device companies have to submit clinical data demonstrating safety and performance of their devices in most LATAM countries (except low-risk devices). MDRC can prepare clinical documentation for your products.
Classification in Brazil and Argentina is rule-based. There are four classes of medical devices in Mercosur countries: class I, class II, class III, class IV. Mexican regulatory authorities (COFEPRIS) classify medical devices based on both rules and substantial equivalence principles and divide medical devices in three classes - I, II, III. Right classification is a basis of smooth and timely regulatory approval process in all LATAM countries. MDRC has a lot of experience with medical device classification in Latin America and will be glad to help you with classifying your products.
An authorized representative of a foreign medical device company must maintain the Post-Market Surveillance System to analyze clinical data and report it to the authorities. Medical device companies must make sure that the representative's Post-Market Surveillance System is in place and works properly. MDRC can inspect your authorized representative's Post-Market Surveillance System on your behalf.
It is not unusual that medical device companies who are interested in the LATAM markets need to actively collaborate with corresponding regulatory authorities. To communicate with the agencies effectively you need to deeply understand local regulatory frameworks. We know regulations of LATAM countries and can take on a lot of communication with the authorities or help you in making your communication with the authorities most effective.
The harmonized standard GMC 20/2011 lays down provisions of Good Manufacturing Practice (GMP) applicable to medical device manufacturers in all Mercosur countries. However, every LATAM country has its own quality management standards (BGMP in Brazil, Argentinian GMP in Argentina etc.) MDRC will help you implement a Quality Management System that complies with all requirements applicable on your strategic markets.
In LATAM countries almost all high-risk devices require clinical investigations. Usually, regulatory authorities recognize clinical investigations conducted abroad provided that they comply with the international clinical research standards. MDRC will help you figure out what investigations are required, how to conduct them efficiently, what investigations can be waived etc. We also can organize clinical investigations for you.
Technical documentation of medical devices in Latin American countries should conform to local standards that often differ from the EU and US regulations. MDRC can prepare technical documentation for your devices that complies with the regulatory requirements of LATAM countries (ANVISA, ANMAT, COFEPRIS and other national agencies).
Foreign medical device manufacturers are obliged to make sure that their authorized representatives in LATAM countries maintain risk management systems compliant with local regulations. MDRC can inspect your authorized representative's risk management system on your behalf.
Medical device companies have to submit clinical data demonstrating safety and performance of their devices in most LATAM countries (except low-risk devices). MDRC can prepare clinical documentation for your products.
Classification in Brazil and Argentina is rule-based. There are four classes of medical devices in Mercosur countries: class I, class II, class III, class IV. Mexican regulatory authorities (COFEPRIS) classify medical devices based on both rules and substantial equivalence principles and divide medical devices in three classes - I, II, III. Right classification is a basis of smooth and timely regulatory approval process in all LATAM countries. MDRC has a lot of experience with medical device classification in Latin America and will be glad to help you with classifying your products.
An authorized representative of a foreign medical device company must maintain the Post-Market Surveillance System to analyze clinical data and report it to the authorities. Medical device companies must make sure that the representative's Post-Market Surveillance System is in place and works properly. MDRC can inspect your authorized representative's Post-Market Surveillance System on your behalf.
It is not unusual that medical device companies who are interested in the LATAM markets need to actively collaborate with corresponding regulatory authorities. To communicate with the agencies effectively you need to deeply understand local regulatory frameworks. We know regulations of LATAM countries and can take on a lot of communication with the authorities or help you in making your communication with the authorities most effective.
The harmonized standard GMC 20/2011 lays down provisions of Good Manufacturing Practice (GMP) applicable to medical device manufacturers in all Mercosur countries. However, every LATAM country has its own quality management standards (BGMP in Brazil, Argentinian GMP in Argentina etc.) MDRC will help you implement a Quality Management System that complies with all requirements applicable on your strategic markets.
In LATAM countries almost all high-risk devices require clinical investigations. Usually, regulatory authorities recognize clinical investigations conducted abroad provided that they comply with the international clinical research standards. MDRC will help you figure out what investigations are required, how to conduct them efficiently, what investigations can be waived etc. We also can organize clinical investigations for you.
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We have a lot of experience putting medical devices on LATAM markets and can help you achieve regulatory compliance with all local regulations applicable to your devices. Also, we can find Authorized Representatives in countries you are interested in as well as select and qualify distributors in Brazil, Argentina, Mexico and other Latin American countries.
We have a lot of experience putting medical devices on LATAM markets and can help you achieve regulatory compliance with all local regulations applicable to your devices. Also, we can find Authorized Representatives in countries you are interested in as well as select and qualify distributors in Brazil, Argentina, Mexico and other Latin American countries.
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