Medical device manufacturing is one of the main subsectors under the umbrella of Mexico’s healthcare industry, exporting over $16 billion USD in medical devices and equipment in 2022. Mexico, especially the state of Baja California, offers plenty of advantages for medical device manufacturing for foreign companies.
With ideal locations right along the U.S./Mexico border, companies like Medtronic, Becton Dickinson, Intuitive Surgical, Stryker, and Masimo see quick turnaround times from order to delivery for high-mix/low-volume medical device manufacturing. Also, there’s the benefit of being in close proximity to San Diego, CA, the United States’ fourth-largest life sciences technology hub, where many Mexican professionals get additional training at its top universities and institutions.
With 40+ years of shelter experience, IVEMSA has worked with companies across multiple industries, of all sizes, and in every part of the supply chain. This provides you with the local experience, expertise, and network to get production up and running as efficiently as possible.
Over the years, Baja California has become a world leader in medical device manufacturing, with facilities that are FDA, CE, and ISO 13485 certified and have clean rooms from class 100 to 100,000. Medical device manufacturing companies in Mexico produce FDA Class I, II, and III products—which are subject to the same safety regulations as those manufactured in the U.S.
Furthermore, new provisions per the USMCA focus on patent and intellectual property protection as well as streamlining processes for medical device production. Due to the intense regulatory requirements and changing legal provisions, the majority of foreign manufacturers find it beneficial to work with a shelter company. A shelter provides regulatory compliance measures to keep companies protected and in line with federal and local laws and safety processes and procedures.
This unique partnership allows companies to focus on production growth and strategy while delegating administrative responsibilities to shelter experts. A shelter also helps U.S. and other foreign companies save on manufacturing costs including labor, and transportation. Plus, under the shelter umbrella, companies benefit from IMMEX certification, which exempts them from the 16% value-added tax on all temporarily imported goods, machinery, and materials.
As a result, medical device manufacturing in Mexico continues to be one of the leading sectors, and companies around the world continue to pursue shelter solutions to expand their reach and meet rising economic demand in a competitive market.
IVEMSA will help you recruit from a pool of employees who have taken extensive training where they’ve learned about the high standards and requirements necessary in medical device manufacturing. Many foreign operators choose to partner with local universities for specific training programs to acquire the skills and workers needed for production. The availability and skill level of Mexico’s labor force adds to the competitive advantages of nearshore manufacturing and helps support growth in this sector.
Because the medical device manufacturing industry in Mexico is already strong, facilities are already set up along main transportation lines and supply channels, integrating easily into your operational flow. With competitive time-to-market demand, you can rely on the infrastructure in place to accommodate business timelines and goals. We’ll help you source the optimal site location and ensure all permits and licensing is in place ahead of time, saving on time and costs.
With the U.S. as a prime market, the proximity to Mexico makes it an ideal location to keep with industry demand. IVEMSA has years of experience working in Baja California, where over half of Mexico’s medical device manufacturing facilities are found. As part of our full suite of shelter services, we provide a site selection analysis. This is an in-depth look at several factors, including lease rates, labor force availability, and transportation options, to help you narrow down and maximize your facility options.
Though site selection is the first step, our shelter services also include attention to HR and recruiting, tax and accounting, and environmental health and safety. We can also provide relocation assistance for plant managers moving to Mexico and research and help you qualify for incentive programs available. And we’ll guide you through USMCA and other trade agreements along with import/export and trade compliance. Services are customized per each company’s specific goals to optimize efforts to create lasting success.
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