IPSNEWS

Tariff Landscape for Medical Devices Mexico-U.S.

Tariff Landscape for Medical Devices Mexico-U.S.

On April 2, 2025, the United States government announced the implementation of "reciprocal tariffs" on multiple countries, establishing a base tariff of 10%. However, a week later, a 90-day pause was applied for most trading partners; nevertheless, tariffs on China were simultaneously increased. This decision is part of a strategy aimed at correcting trade balance imbalances and strengthening the U.S. domestic industry.

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The Importance of sharing updated documentation in Medical Device distribution

The Importance of sharing updated documentation in Medical Device distribution

In the medical device sector, safety and regulatory compliance are fundamental to ensuring quality and protecting patients. A key aspect of this process is traceability within the supply chain. As distributors, sharing updated information, such as the Notice of Operation and the Registration of the Tecnovigilance Unit, with the sanitary registration holder is not only a regulatory obligation but also an essential practice to ensure operational continuity and avoid setbacks in procedures with COFEPRIS.

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Regulatory Update COFEPRIS Simplifies Sanitary Procedures
Regulatory Update IPS Regulatory Update IPS

Regulatory Update COFEPRIS Simplifies Sanitary Procedures

The Federal Commission for Protection against Sanitary Risks (COFEPRIS), through an Agreement published in the Official Gazette of the Federation (DOF) on March 27, 2025, will simplify health supplies procedures. Starting 15 working days after publication, procedures for establishment operation notices (COFEPRIS-05-006) and modifications/cancellations (COFEPRIS-05-007) will be merged, and the requirement to submit the "Operation Notice, Sanitary Responsible, and Modification or Cancellation Notice" form and the "Original Responsible Notice, for the case of sanitary responsible cancellation" will be eliminated.

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