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Insights into regional medical devices regulatory affairs to reach LATAM

Article-Insights into regional medical devices regulatory affairs to reach LATAM

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Selecting skilled and suitable regulatory partner is critical; sidelining regulatory issues may lead to serious company risks.

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.

MMGC chart

In MMGC SRL, we usually see that clients launching in the region have an in-house regulatory staff strongly oriented to, and highly specialized in, European medical devices regulations (MDR), FDA regulations or others. However, when entering the Latin America region, they are not familiar with the local healthcare regulations.

In such cases, we recommend they seek support by outsourcing their Regulatory Affairs Management in the region, particularly at the beginning. In this way MMGC usually works by centralizing the regional regulatory issues in close cooperation with their in-company staff to define the best regulatory strategy for each country and, as we share the same regulatory language, the communication among the people involved is fluent.

Currently, several Latin American regulatory agencies are gradually migrating from long and heavy paper-based procedures to online submissions for medical device registrations and license renewals. Nevertheless, as mentioned above, the implementation of these updates is usually gradual and highly based on practical experience acquired on the go by the regulatory authority.

To manage medical device registrations efficiently, it is critical to have expertise and knowledge of these local characteristics.

On the other hand, there are some common guidelines that allow to group countries and manage regulatory issues of Latin American countries in a centralized way.

Centralized Regional Management of Regulatory Affairs offers advantages and avoids extra costs and delays in registrations. In addition, manufacturers have the option to start with one Latin American country of interest and to expand the market to other countries afterwards, therefore optimizing the use of documentation.

MMGC SRL is a Consultancy Company that specializes in Medical Device Regulatory Affairs, a company composed of a multidisciplinary team of professionals that combines training and more than 25 years of expertise from the public and private sectors. We have extensive experience working with international medical device companies to gain regulatory access to markets in Latin America. The tailored-service approach we offer enables us to provide solutions to large, medium and small-sized companies, as well as to serve local and international businesses and local direct distributors.

Monica Mabel Guaita is the CEO and Founding Partner of MMGC SRL (a regulatory affairs consulting firm), and Magdalena Ferrari del Sel is a Regulatory Affairs International Senior Consultant. Monica will speak as part of the “Main Regulatory Issues for LATAM — How to Surf LATAM's Regulatory Issues” session on June 20.

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