In January 2025, Argentina officially adopted the new MERCOSUR Technical Regulation for the Registration of Medical Products (GMC Resolution No. 25/21), replacing the previous GMC Resolution No. 40/00. This marks a significant shift in the regulatory landscape for medical products, aiming to create a more standardized and efficient registration process across the MERCOSUR region, which includes Argentina, Brazil, Paraguay, Uruguay, and Bolivia.

The new regulation introduces several key changes, including:

• Harmonization of Documentation and Classification:It standardizes the requirements for product classification and documentation across MERCOSUR countries. This will reduce inconsistencies in the registration process and simplify the submission of required materials.

• Recognition of Foreign Data:The new regulation encourages the use of foreign registration data, which can expedite the registration process for products already approved in other MERCOSUR countries or recognized reference markets.

• Streamlined Approval Timelines:The regulation aims to synchronize approval timelines across all member states, providing a more predictable and coordinated process for market entry.

ANMAT, the Argentine regulatory authority, will oversee the implementation of these changes within Argentina, ensuring compliance with the new regulation.

While the regulation is now in effect in Argentina, some countries in the MERCOSUR region have already implemented similar changes, while others are still considering the adoption of these new rules. As a result, we currently do not have a full view of when the regulation will be fully implemented across all member states. However, the adoption in Argentina marks a crucial step forward in the regional regulatory landscape.

At LAMA, we are committed to keeping our clients and partners informed about the latest developments. As this regulation continues to evolve, we will be your trusted source for updates and insights, ensuring that your business stays ahead of regulatory changes in Argentina and throughout Latin America.

Stay tuned for further updates as we continue to monitor the full implementation of the MERCOSUR regulation and its impact on medical device registration in the region.

For more details, you can read the official announcement here.

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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.