Uruguay adopts MERCOSUR standards for medical devices and IVDs

Uruguay issued Commercial Information Circular No. 393/2025, announcing implementation of Decree No. 498/025 which integrates into national law the MERCOSUR Common Market Group (GMC) Resolution No. 07/24. This resolution mandates that medical devices and in-vitro diagnostics (IVDs) meet enhanced safety and performance requirements for MERCOSUR member states. 

The decree means that device importers, distributors and manufacturers in Uruguay must align their products and documentation to the bloc’s unified standard — including risk-classification criteria, traceability, Spanish/Portuguese labeling and technical compliance. This harmonisation aims to enable devices approved under the MERCOSUR standard to flow more easily across member countries, while strengthening consumer protection in Uruguay.

For the import device sector, this is both a challenge and an opportunity: a challenge because the requirements may be stricter and adaptation may take more time, but an opportunity because alignment with regional standards means greater market flexibility and the possibility of using Uruguay as an entry-point into neighbouring markets.

Sources:

• “Uruguay: Requirements for Medical Devices and In Vitro Medical Devices.” Trade Circular No. 393/2025, 28 Apr 2025. Link