{"id":3996,"date":"2025-06-12T22:27:16","date_gmt":"2025-06-12T22:27:16","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=3996"},"modified":"2025-06-12T23:54:21","modified_gmt":"2025-06-12T23:54:21","slug":"mexico-encourages-investment-to-strengthen-its-medical-device-industry","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/mexico-encourages-investment-to-strengthen-its-medical-device-industry\/","title":{"rendered":"Mexico Encourages Investment to Strengthen Its Medical Device Industry\u00a0"},"content":{"rendered":"

In this article, we will explain the implications of the <\/span>Official Decree published on June 2, 2025,<\/span><\/a> in the Official Mexican Diary and how it presents new opportunities for foreign medical device manufacturers interested in establishing operations in Mexico.\u00a0<\/span>\u00a0<\/span><\/p>\n

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The Decree, structured into five articles, sets a framework for promoting<\/span> investment (national or foreign) <\/span><\/b>in the country while strengthening the medical device industry and the production of related health supplies.<\/span>\u00a0<\/span><\/p>\n

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Closely aligned with the Mexico\u2019s National Development Plan (NDP) 2025-2030 (Mexico Plan), this strategy promotes <\/span>public-private collaboration (considering foreign investors), equitable economic growth, and strengthens local industry<\/span> by expanding the use of nationally sourced materials and components in manufacturing. <\/span>\u00a0<\/span><\/p>\n

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What are the key Objectives of the New Regulation?<\/span><\/b>\u00a0<\/span><\/h3>\n

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As outlined in Article 1, the Decree establishes three interconnected goals:<\/span>\u00a0<\/span><\/p>\n

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  1. Encourage investment<\/span><\/b> in Mexico to strengthen the development of the health industry, <\/span>including medical devices<\/span><\/b>.<\/span>\u00a0<\/span><\/li>\n
  2. Promote scientific research and <\/span>innovation in healthcare-related products<\/span><\/b> within the country.<\/span>\u00a0<\/span><\/li>\n
  3. Ensure free market participation<\/span><\/b> while securing the best possible conditions for the Mexican government in the development of the healthcare sector.<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

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    Opening Investment Opportunities for Foreign Manufacturers<\/span><\/b>\u00a0<\/span><\/h3>\n

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    Article 2 is particularly relevant for foreign manufacturers<\/span>, as it opens the door to new investment projects that <\/span>encompass complete or just specific steps of the production chains<\/span><\/b>, including assembly, sterilization, and other processes.<\/span>\u00a0<\/span><\/p>\n

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    This article establishes the general framework for encouraging the participation of companies with a local commitment. Companies can prove this connection through three criteria:<\/span>\u00a0<\/span><\/p>\n

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    1. Investment in Mexico\u2019s production chain: <\/span>any contribution to different stages<\/span><\/b> of medical device manufacturing within the country.<\/span>\u00a0<\/span><\/li>\n
    2. Establishment of factories, laboratories, or warehouses<\/span><\/b>: companies that have begun constructing or adapting production plants, R&D laboratories, or distribution centers in Mexico.<\/span>\u00a0<\/span><\/li>\n
    3. Scientific research or development of innovative health products:<\/span><\/b> firms conducting scientific studies or developing cutting-edge medical devices in Mexico.<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

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      Regulatory Streamlining to Accelerate Market Entry<\/span><\/b>\u00a0<\/span><\/h3>\n

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      Article 3 focuses on regulatory acceleration, with <\/span>COFEPRIS<\/span><\/a> playing a crucial role in streamlining administrative procedures such as:<\/span>\u00a0<\/span><\/p>\n