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.

This new trade policy significantly impacts the global medical device (medtech) industry, which relies on imported components such as sensors, chips, plastics, and metals, mainly from Asia. The increased cost of these inputs raises production costs for American companies, while also generating uncertainty and causing delays in supply chains.

In response to these measures, several international companies in the medtech sector have accelerated their investments in production facilities within the U.S., although they have warned that relocating manufacturing domestically will require considerable time and resources.

Against this backdrop, in the North American region, the United States-Mexico-Canada Agreement (USMCA) serves as the primary regulatory framework for trade in medical devices among the parties, with any disputes to be resolved in accordance with the provisions of the agreement.

In this regard, the agreement stipulates that products originating in Mexico that comply with the rules of origin set forth in the USMCA benefit from a 0% tariff upon entry into the United States. These rules specify the required level of regional content, and compliance is essential for Mexican manufacturers to maintain their competitiveness and preferential access to the U.S. market.

Likewise, it is important to briefly highlight the 25% tariff on steel and aluminum, in effect since March 2025, which may impact the production costs of medical devices that utilize these materials, regardless of their origin under the USMCA.

In this context, the key strategy for the Mexican medical device industry is to ensure strict compliance with USMCA rules of origin to maximize the benefits of the zero-tariff provisions. At the same time, it is crucial to closely monitor the evolution of U.S. trade policies and assess supply chains to mitigate the impact of tariffs on materials such as steel and aluminum. Adaptation and a thorough understanding of the USMCA are essential to successfully navigate the current tariff landscape.

Finally, with the aim of diversifying its markets, the Mexican medical device industry may consider establishing trade alliances with partners benefiting from favorable tariff agreements, with the European Union being a notable example. Thanks to the Free Trade Agreement between Mexico and the European Union (FTA EU-MX), imports of medical devices originating in the EU may be exempt from tariffs. To access this benefit, it is essential to comply with the required documentation, which includes the EUR.1 certificate of origin or a declaration on the commercial invoice certifying the European origin of the goods, incorporating the EU authorized exporter number in the latter case.

At IPS, our team is deeply committed to providing clients with a comprehensive perspective—both nationally and internationally—on the key aspects of these decisions, as well as their potential regulatory, commercial, and operational implications for the industry.

This matter will continue to be closely monitored and analyzed.

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At IPS, our team is deeply committed to providing clients with a comprehensive perspective—both nationally and internationally—on the key aspects as well as their potential regulatory, commercial, and operational implications for the industry. Don't hesitate to contact us at info@insumosparasalud.com if you need help.