In this article, we will explain the implications of the Official Decree published on June 2, 2025, in the Official Mexican Diary and how it presents new opportunities for foreign medical device manufacturers interested in establishing operations in Mexico.
The Decree, structured into five articles, sets a framework for promoting investment (national or foreign) in the country while strengthening the medical device industry and the production of related health supplies.
Closely aligned with the Mexico’s National Development Plan (NDP) 2025-2030 (Mexico Plan), this strategy promotes public-private collaboration (considering foreign investors), equitable economic growth, and strengthens local industry by expanding the use of nationally sourced materials and components in manufacturing.
What are the key Objectives of the New Regulation?
As outlined in Article 1, the Decree establishes three interconnected goals:
- Encourage investment in Mexico to strengthen the development of the health industry, including medical devices.
- Promote scientific research and innovation in healthcare-related products within the country.
- Ensure free market participation while securing the best possible conditions for the Mexican government in the development of the healthcare sector.
Opening Investment Opportunities for Foreign Manufacturers
Article 2 is particularly relevant for foreign manufacturers, as it opens the door to new investment projects that encompass complete or just specific steps of the production chains, including assembly, sterilization, and other processes.
This article establishes the general framework for encouraging the participation of companies with a local commitment. Companies can prove this connection through three criteria:
- Investment in Mexico’s production chain: any contribution to different stages of medical device manufacturing within the country.
- Establishment of factories, laboratories, or warehouses: companies that have begun constructing or adapting production plants, R&D laboratories, or distribution centers in Mexico.
- Scientific research or development of innovative health products: firms conducting scientific studies or developing cutting-edge medical devices in Mexico.
Regulatory Streamlining to Accelerate Market Entry
Article 3 focuses on regulatory acceleration, with COFEPRIS playing a crucial role in streamlining administrative procedures such as:
- Medical device sanitary registrations.
- Scientific research protocols.
- Export certificates.
- Import permits for raw materials to foster local manufacturing.
By simplifying these procedures, Mexico makes it easier for foreign medical device manufacturers to enter the market while reducing costs and administrative burden. It is understood in the decree that COFEPRIS will focus its attention on companies investing in the country.
A New Evaluation System: Competitive Advantage for Investors
Article 4 introduces a new points-based evaluation method in public tenders. This system will assess quality, experience, and significantly local contributions to Mexico’s industrial development.
Practically speaking, this means that in a bidding process, a company that offers a competitive price while complying with technical and quality standards, and also demonstrates investment in Mexico or scientific research, will receive extra points. This advantage could be decisive in securing contracts.
Conclusions
With this new regulatory framework, foreign manufacturers looking to expand into Mexico have an unprecedented opportunity to invest in production, partner with the government, and gain competitive advantages in procurement processes.
To capitalize on these incentives, companies can start by evaluating their manufacturing strategies and alignment with Mexico’s healthcare industry. Contact Veraque for more information on entering the market under this new regulation.
