Brazil and Argentina Enhance Trade Relations and Pave the Way for Medical Product Regulation in Mercosur.

In 2018, within the framework of the Summit of Heads of Member States of Mercosur held, Brazil and Argentina signed a joint declaration on Regulatory Convergence and Trade Facilitation, aiming to strengthen their bilateral relationship.

The trade facilitation proposal resulted in initiatives geared towards reducing costs and time in commerce. This was achieved through the analysis of import and export procedures and requirements.

The recommendations underscored the importance of enhancing the integration of national systems and streamlining commercial regulations, procedures, and documents.

As a tangible outcome of this agreement and to further bolster the Mercosur bloc, on November 8th, the National Administration of Drugs, Foods, and Medical Technology (ANMAT) of Argentina and the National Health Surveillance Agency (ANVISA) of Brazil signed the first mutual recognition agreement on certificates for medical products. Specifically, this agreement covers the “Mutual Recognition Agreement for Certificates of Free Sale and Certificates for Foreign Country for Medical Devices of Risk Classes I and II, and In Vitro Diagnostic Medical Devices of Risk Classes A and B”. This marks a strengthening of trust in the decisions of both agencies and recognition of the efforts each makes to safeguard public health. Simultaneously, it will streamline regulatory processes in both agencies.

References:

If you’re considering expanding your brand into the LATAM market, our consultancy is here to support you every step of the way, including in the exciting realm of nanomedicine and cosmetics. Together, we can unlock the full potential of your brand in this vibrant and growing market.