Regulatory Approval of Medical Devices in Brazil and Mexico – Inhouse Training

Successful Medical Device Registration in Brazil and Mexico

The registration of medical devices in Brazil and Mexico is crucial for gaining market access in Latin America. Both countries have independent, stringent regulatory frameworks, and successfully navigating these frameworks opens the door to these important markets. Approval in Brazil and Mexico can also serve as a springboard for other countries in the region.

In Brazil, the Agência Nacional de Vigilância Sanitária (ANVISA) is responsible for the safety, quality control, andvigilance of medical devices. Medical devices are regulatedin accordance withRDC No. 751/2022 and other specific regulations and are classified into four risk classes (I, II, III, IV). All products must be registered, and international manufacturersare required tohave a local Brazilian representative.

In Mexico, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) oversees the monitoring and regulation of medical devices. Here, too, there is a classification into risk classes (Class I, II, III), with all medical devices requiring approval. Either through notification or registration – depending on their class. International manufacturers need an authorized Mexican representative.

What makes our seminar unique?

In this interactive seminar, you’ll learn about thevarious regulatory requirements in Brazil and Mexico. Using your products as examples, we’ll show you which approval processes are relevant in each country and how to navigate them successfully.

With plenty of clear examples and practical tips, we’ll prepare you thoroughly for product approval in both countries.