Medical Device Manufacturing in Mexico

With a thriving medical device manufacturing industry in Mexico, the country is making a significant contribution to the global healthcare landscape. The nation ranks seventh among main medical exporting countries in the world. It is the leader in Latin America.

Mexican Talent for Medical Device Manufacturing

The industry has seen continual growth in employment due to steady investment and consolidation of the sector in Mexico.

Universities are adapting career paths in biomedical engineering, prosthetics manufacturing, chemical pharmaceutical biology, among others. For example, in the 2022-2023 academic year, over 150,000 students graduated from careers related to medical device manufacturing.

Medical Device Clusters in Mexico

Several regions in the country have become focal points for the medical device industry in Mexico. They host clusters that facilitate collaboration, innovation, and efficiency.

Among the clusters are the Mexican states of Baja California, Sonora, Chihuahua, Jalisco, Nuevo León, Tamaulipas, and the Mexico City Metropolitan Zone.

• Baja-Sonora - the primary cities in the zone are Tijuana and Mexicali, both along the U.S.-Mexico border. Generally, the cluster is characterized by robust exports of medical devices from large, foreign corporations that operate in the state. Nearly half of the country's medical device employment in concentrated in the state of Baja California. Neighboring Sonora adds another 15,000 employees.
• Chihuahua - the border city of Ciudad Juárez concentrates the majority of medical device manufacturing in the state. Being that, Chihuahua employs about 40,000 employees in the sector.
• Guadalajara - often referred to as the "Silicon Valley of Mexico", Guadalajara has a niche for electronic and high-tech medical device production. Thus it is known for its R&D footprint in the industry, seeking to become the innovation hub of Mexico.
• Northeastern Mexico - the state of Nuevo León boasts a thriving medical device industry. Products produced in the state range from surgical instruments to advanced imaging systems. It is the leading state for the production of electronic medical equipment. Neighboring Tamaulipas employs over 15,000 workers in the medical device industry throughout border cities like Nuevo Laredo, Reynosa and Matamoros.
• Mexico City Metro Zone - as the country's capital and economic hub, the cluster is home to a diverse range of medical device companies. They are mostly mid-sized, domestic capital companies that tend to operate various functions under one roof: from R&D to distribution to customer service. Manufacturers mainly focus on domestic market, and sometimes export to Central or South America.

Download the full Medical Device Industry in Mexico e-book to see the trade data for each cluster, by medical device classification.

Medical Device Companies in Mexico

Mexico's adeptness in harnessing skilled labor, coupled with competitive production costs, has attracted numerous multinational corporations seeking efficient and cost-effective medical device manufacturing solutions. Some of the major companies in the industry in Mexico include: 

• Medline Medline Industries has positioned itself as the leading company in its niche in more than 90 countries. It generates more than 20 thousand jobs, and managing to effectively promote and guarantee public health. Medline operates 20 plants in North America, including a total of 4 plants in Mexico.
• Philips Healthcare Philips, a multinational conglomerate, has a significant presence in the healthcare sector, including the manufacturing of medical devices. The company’s headquarters are in Mexico City where they employ 718 Mexican workers that produce healthcare technology for both public and private hospitals. Among the items that it produces in Mexico is a digital PET-CT solution that is capable of diagnosing cancer quickly and accurately. 
• Siemens Healthineers Siemens Healthineers, a division of Siemens AG, develops and manufactures medical devices and has a presence in Mexico. The company’s facility in Tijuana, Baja California, manufactures high-end components and equipment for radiotherapy. 
• Medtronic A global leader in medical technology, Medtronic has manufacturing operations in various locations worldwide, including Mexico. Today, Medtronic operates six facilities in Mexico including a large plant in Tijuana, Baja California. In total, the company employs 15,000 Mexican workers. 
• Becton Dickinson (BD) BD, a global medical technology company, manufactures and sells medical devices, instrument systems, and reagents. They have been known to have operations in Mexico. Becton Dickinson has a total of twelve manufacturing plants in Mexico. 
• Abbott Laboratories Abbott is a diversified healthcare company with a wide range of products, including medical devices. Abbott Laboratories de México SA de CV is located in Mexico City. It supports Nutritional Products, Medical, Pharmaceuticals, Vascular, Molecular, Diagnostics, and Diabetes Care. 
• Johnson & Johnson Johnson & Johnson, a diversified healthcare company, operates in Mexico and engages in the manufacturing of medical devices along with pharmaceuticals and consumer health products. Johnson & Johnson de México, S.A. de C.V. has a headquarters in Mexico City. 
• Boston Scientific Boston Scientific is a prominent medical device company that specializes in the development and manufacturing of innovative medical technologies, and they may have operations in Mexico. Its latest facility is a US 38.6 million dollar medication management manufacturing plant in Tijuana, Baja California.
• GE Healthcare General Electric's healthcare division, GE Healthcare, develops and manufactures medical devices and diagnostic equipment. The company operates a manufacturing facility in Monterrey, Nuevo León. 
• Cardinal Health Cardinal Health is a global manufacturer and distributor of medical and laboratory products, operating in over 30 countries. Cardinal Health employees about 5,500 people in the company’s five manufacturing facilities in Mexico. 
• Stryker Corporation Stryker is a leading medical technology company known for its products in orthopedics, medical and surgical, and neurotechnology. Mexico is home to two Stryker locations.  Its Mexico City headquarters supports several of Stryker's businesses including Medical, Surgical, Orthopaedics, Spine, and Neurotechnology. Its Tijuana manufacturing facility supports Stryker’s Sustainability Solutions. 
• Welch Allyn Welch Allyn is one of the largest medical companies in Tijuana. They are a global manufacturer of frontline medical products and solutions, specifically diagnostics devices, as well as patient monitoring systems and vital signs devices. They produce thermometers in their Tijuana facility.

Medical Device Manufacturing in Mexico

Mexico is an important importer of medical device equipment. Much of it used in regional supply chains and destined for the U.S. consumer market. In fact, Mexico is the world leader for the production of pacemakers, syringes, sutures, and surgical needles. Mexico is also home to the innovative, intravenous catheter known as the “butterfly”, which is used globally (ANAPS).

According to ANAPS, the National Association for Health Providers in Mexico, Mexico has become the world leader in the fabrication of medical supplies. It has a production cost 25% lower than the United States and 6% lower than China. There are many types of medical devices manufactured in Mexico, including:

• Diagnostic Equipment: Mexico is a key producer of diagnostic devices, encompassing imaging technologies, laboratory equipment, and rapid testing kits.
• Surgical Instruments: The country manufactures a range of surgical instruments, from basic tools to advanced robotic-assisted surgical devices.
• Implants and Prosthetics: Mexico has a strong presence in the production of orthopedic implants, dental implants, and other medical devices related to prosthetics.
• Electronic Monitoring Devices: With a focus on technological innovation, Mexico contributes to the production of electronic monitoring devices used in healthcare settings.
• Consumables: The manufacturing of medical consumables, such as syringes, catheters, and wound care products, is also a significant part of Mexico's medical device industry.

Mexico Trade Data by Type (2023) by Foreign Corporations in Mexico

Download the e-book to see the countries or origin and destination of the imports and exports by type.

Mexican Medical Device Regulatory Bodies

Mexico’s medical device industry is experiencing a boom, driven by its proximity to the United States market, skilled workforce, and competitive production costs. However, entering this market requires a thorough understanding of the regulatory landscape in Mexico. The Mexican regulatory framework for the medical and pharmaceutical sectors includes the following norms and registration requirements:

Mexican Official Standards. Compliance with Mexican Official Standards (Normas Oficiales Mexicanas or NOMs) is mandatory for all products sold in the Mexican territory.

Sanitary Registration. In addition to NOMs, companies register their medical devices (as well as pharmaceutical products) with COFEPRIS. Intellectual property protection is a separate process with a different government agency. Under the USMCA, COFEPRIS has established an equivalence procedure. This allows for market authorizers to streamline product approvals for devices and pharmaceuticals containing active ingredients that have not been commercialized before in Mexico. Industry sources have indicated that this process has not been as fast as expected. The USMCA states that the equivalence determination should take between five and six working days. However, the process currently takes between five and seven months. For the registration of generic drugs, there is a requirement to conduct the corresponding bioequivalence studies in Mexico. Only in some cases, such as personal use or research, are products exempted from being registered.

Import Permit. Once the product has obtained a sanitary registration code, the importer must file an import permit application with COFEPRIS to have access to the Mexican territory. This process also applies to the import of products for personal use or research exempted from sanitary registration.

Certificate of Origin. Products qualifying as North American under USMCA require a minimum set of nine data elements to prove origin and receive USMCA beneficial treatment. The importer, exporter, or producer may issue this certification. But it does not have to be validated or formalized. Only North American products, as defined by the rules of origin, are eligible for preferential tariff treatment. 

Opportunities for Medical Device Companies in Mexico

Many opportunities exist in Mexico that point to continued growth in the medical device sector. Mexico’s geographical location allows companies to respond to global demands and take advantage of shifting market needs by manufacturing close to the top global market, the United States.

Overall, Mexico’s domestic sector represents a great opportunity for foreign and domestic investors in the medical device sector. Expenditures or medical services are primarily consolidated in a public health system.

Total healthcare expenditure, including medical devices, accounts for about 5% of Mexico’s GDP (2022). Mexico continues to import a large quantity of required medical devices, further leaving opportunities for investment in domestic production. 

The Global Medical Device Industry: an Overview

The global medical device market was valued at $536 billion dollars in 2023, with a projection upwards of $800 billion by 2030. The North American market accounts for about 38% of that. Generally speaking, there are many reasons for this growth, mostly attributed to the advancements in healthcare that increase diagnostics and medical procedures. In fact, many of the industry’s top companies report increases in R&D spending.

Global population aged 60 years and over will more than double by 2050.

Despite these attractive prospects for growth, a relentless downward pressure in pricing continues. Governments around the globe are desperately trying to reduce the cost of healthcare. Additionally, many purchasing decisions have moved from clinical to economic buyers.

According to KPMG’s “Medical Devices 2030” report, value is the new byword for success, prevention the preferred clinical outcome and intelligence the new competitive advantage. Therefore the pathway to success in 2030 includes:

• Reinventing traditional business and operating models by integrating intelligence, delivering services beyond the device, and investing in enabling technology
• Repositioning for the future competitive landscape, to adapt to challenges presented by new entrants, new technologies, and new markets
• Reconfiguring your position in the value chain of the future, by connecting directly with patients and consumers (B2C), vertically integrating (B2B), and/or transforming into “one stop shops” for care.

Conclusion: Mexico's Contribution to the Medical Device Industry

Mexico has steadily increased its share of the global medical device manufacturing market. As of the last available data, the country accounted for a significant portion of the world's medical device production, with estimates suggesting a share of around 3-4%. This demonstrates Mexico's growing importance in meeting global healthcare demands and supplying medical devices to markets worldwide.

The medical device industry in Mexico also plays a crucial role in providing employment opportunities. With a skilled and specialized workforce, employed across various roles including engineers, technicians, quality control specialists, and assembly line workers. The industry's contribution to job creation further bolsters its significance within the broader Mexican economy.

The medical device industry in Mexico holds substantial economic importance for the country. While specific figures may vary, estimates suggest that the sector contributes 1.5% of all manufacturing gross domestic product (ANAPS). The per annum growth of the industry over the last several years has reached a rate of 3%. 

Mexico's medical device exports have seen consistent growth. This reflects both the competitiveness of its products and the increasing global demand for high-quality medical devices. The value of exports from the Mexican medical device industry contributes significantly to the country's overall export revenue, further highlighting its role in the international trade landscape.

The medical device industry in Mexico has evolved into a dynamic and indispensable player in the global healthcare landscape. Particularly, Mexico has diverse production capabilities, strategic clusters, a skilled workforce, and a commitment to innovation. This allows Mexico to continue to attract major multinational corporations seeking a competitive edge in the production of medical devices. In essence, the industry's economic contribution, job creation, and global market share underscore its pivotal role in Mexico's manufacturing sector and the broader international healthcare ecosystem.

The medical device industry in Mexico holds strategic importance for the country's economy. Additionally, the industry's presence has spurred the development of industry clusters in regions such as Tijuana, Mexicali, Guadalajara, and Mexico City. This fosters collaboration and knowledge-sharing. Overall, the medical device industry's impact extends beyond economic metrics. It influences healthcare infrastructure, technological advancements, and Mexico's role as a key player in the global healthcare market.

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