Insights into regional medical devices regulatory affairs to reach LATAM

 

The Latin American region comprises 20 countries (depending on classification/sources), many of which are categorized as emerging countries with a population that is estimated to have reached 657 million people as of 2024 (CEPAL).

The Latin American market, with several local manufacturers, has outstanding world-renowned professionals who are highly trained in using the latest technology, research and development. Therefore, the region shows a strong trend as an import market for high-tech medical equipment and medical devices.

These are some of the reasons why the Latin American market represents a region of strategic interest for building alliances with qualified partners who have experience in such markets. Disregarding the regulatory issues may imply significant risks for companies that wish to enter the Latin American market. Choosing a skilled and suitable regulatory partner plays an important role in this enterprise and selecting the right one is critical.

Regulatory clearance is a prerequisite for manufacturers to get access to new markets. Latin America poses a challenge for medical device registration as each country has its regulatory legislation or its particular way of applying the same legislation, as it happens among different Mercosur countries.

Although there are different regional trade agreements in force — Free Trade Agreements, Trade blocks, Common Markets, etc. like Mercosur, ALCA, and Pacific Alliance (Alianza del Pacífico) — these agreements do not comprise all countries in Latin America nor have a direct correspondence with a single product regulatory clearance as it happens in the European Union and its medical devices regulations applicable throughout the community and the CE marking.

It may also happen that some countries in this region issue legislations, but these are not applied, or are partially applied taking into account the available resources at the moment of application and/or political and economic changes that impact the system.

Besides, sometimes regulations and requirements to access the Latin American markets change and new requirements are gradually incorporated or are based on practical experience acquired by local RA on the go. This situation, combined with the fact that when the government changes there might be turns in high-level public positions, may result in changes in management and implementation of regulations.

Another aspect that should be considered is the different legislation frameworks regarding medical product license ownership. In general, manufacturers are usually concerned about keeping control of their product licenses and it is exactly at this point where good regulatory advice is fundamental to avoid future problems related to product importation and marketing issues.

MMGC SRL offers manufacturers the possibility to address this issue by thinking together about their regional regulatory strategy and supporting them to make the right considerations to choose among the different holding options possible based on each local legislation.