Medical Device Manufacturing: Start Producing in Mexico’s Growing Industry

The global medical devices industry is projected to reach USD 612.7 billion by 2025, a solid 30% increase between 2020 and 2025. With longer life expectancies, aging populations, and increased access to and developments in medical treatments, this rapid expansion means big opportunities for companies and increased competition to gain market share. More and more medical device manufacturing companies are expanding or relocating to Mexico to capitalize on its multiple benefits.

What is Medical Device Manufacturing?

Medical device manufacturing refers to the design, production, and assembly of equipment, instruments, and machines used in healthcare settings to diagnose, treat, and monitor medical conditions. This industry encompasses a wide range of products, from basic consumables such as syringes and surgical gloves to advanced medical technologies like pacemakers, imaging systems, and robotic surgical devices.

Benefits of Manufacturing Medical Devices in Mexico

• Mexico’s Proximity to the United States. Mexico is the leading exporter of medical equipment and devices to the United States, the 8th largest global manufacturer of medical devices, and home to over 2,500 companies specializing in medical device manufacturing. States with the most significant production include Chihuahua, Tamaulipas, and Baja California. Tijuana is home to the largest number of medical device manufacturing companies in North America. The city’s proximity to San Diego’s National Biotech Cluster, one of the top R&D megaregions in the US for medical investigation, and Tijuana’s productivity hub at the very border with the US have made Tijuana into a top-notch manufacturer of medical equipment.

• World-class quality. Medical device manufacturing in Mexico is globally recognized for its high quality by the world’s most prestigious medical device companies, including Medtronic, Johnson & Johnson, Cardinal Healthcare, Stryker, Medtronic, Becton Dickinson, Philips, GE Medical Systems, and Siemens, to name a few. These and other manufacturers produce FDA Class I, II, and III products, which are subject to the same safety regulations as products manufactured in the US, and meet USFDA standards, with facilities that are FDA, CE, and ISO 13485 certified. Furthermore, the updated USMCA trade agreement, which entered into effect in July of 2020, has promoted further growth and investment in the industry by providing greater certainty for investors. It added several provisions to foster growth in the medical devices industry by streamlining processes for importing medical and pharmaceutical production and harmonizing and enhancing regulatory compatibility.

• Average 20% savings on manufacturing costs compared to China. With the ongoing trend in manufacturing aimed at making supply chains more agile, diverse, and less dependent on China, companies are reshoring manufacturing operations to take advantage of Mexico’s competitive labor rates. In addition to the savings, Mexico’s workforce is also highly skilled. Its triple helix model, with cooperation between industry, academia, and government, means Mexico has thousands of students graduating each year in technical, undergraduate, and graduate programs related to Medical device manufacturing.

• Well-developed supply chain. Over recent decades, this significant growth in the sector has resulted in a well-developed and mature supply chain in the medical devices manufacturing industry in Mexico, meaning companies have access to industry hubs, highly integrated supply chains, and cutting-edge industrial facilities.

Medical Device Companies in Mexico

Conmed

Conmed, a global medical technology company, has been operating in Mexico for several years, specializing in surgical devices and equipment. With a strong presence in Chihuahua, the company benefits from Mexico’s skilled workforce and strategic location, enabling efficient distribution across North America. 

GC Dental

CG Dental focuses on developing and manufacturing high-quality dental technology and equipment, including solutions for dental restorations, prosthetics, and orthodontics. The company’s commitment to precision and durability ensures its products meet the highest industry standards. By establishing operations in Mexico, CG Dental optimizes production efficiency and expands its reach across North and Latin America, providing dental professionals with cutting-edge tools and materials.

Forefront Medical Technology

Forefront Medical Technology manufactures disposable medical devices and precision components globally. With a manufacturing facility in Ciudad Juárez, the company serves a diverse range of healthcare sectors, including respiratory care, drug delivery, and diagnostics. 

BVI

BVI, a global leader in ophthalmic surgical solutions, specializes in high-quality instruments and devices for eye surgery. The company offers a wide range of products, including surgical blades, cannulas, custom procedure packs, and other precision tools designed for ophthalmic procedures. By leveraging Mexico’s industrial infrastructure, BVI enhances its supply chain efficiency and strengthens its ability to serve North and Latin American markets with innovative and reliable surgical solutions.

Thuasne

Thuasne, a French medical device manufacturer specializing in orthopedics and compression therapy, has established operations in Mexico to serve North and Latin American markets. By leveraging Mexico’s industrial infrastructure, Thuasne enhances its supply chain efficiency and expands its global reach.

Medical Devices Manufactured in Mexico

Mexico has established itself as a global hub for medical device manufacturing, producing a wide range of essential healthcare products. The country’s strong industrial base, skilled workforce, and compliance with international quality standards make it an attractive location for manufacturing high-tech medical devices. 

Here are some of the primary medical devices produced in Mexico: 

Surgical and Orthopedic Devices

Mexico is a key producer of surgical instruments, orthopedic implants, and prosthetics. Companies manufacture precision surgical tools, artificial joints, and bone fixation systems, ensuring high-quality standards for global distribution. 

Disposable Medical Supplies

A significant portion of Mexico’s medical device manufacturing sector focuses on disposable healthcare products, including syringes, catheters, IV tubing, wound dressings, and surgical gloves. These products are in high demand for hospitals, clinics, and outpatient care. 

Cardiovascular and Vascular Devices

Mexico plays an essential role in producing cardiovascular and vascular devices, such as stents, pacemakers, and blood pressure monitoring equipment. These devices require advanced manufacturing techniques to meet strict global health regulations. 

Respiratory and Anesthesia Equipment

With a growing demand for respiratory care solutions, manufacturers in Mexico produce ventilators, oxygen masks, nebulizers, and anesthesia machines. The pandemic accelerated investment in this sector, reinforcing Mexico’s importance in global medical equipment supply chains. 

Diagnostic Equipment

Mexico’s medical device industry also includes the production of diagnostic imaging and laboratory equipment. This includes ultrasound machines, X-ray systems, blood analyzers, and point-of-care testing devices, which are crucial for early disease detection and treatment planning. 

Ophthalmic Devices 

The country is a major producer of ophthalmic surgical tools, intraocular lenses, and vision correction equipment, supporting both elective and essential eye care treatments worldwide. 

By manufacturing a diverse range of medical devices, Mexico continues to strengthen its position as a leader in the global healthcare supply chain. Its strategic location, cost-effective production, and adherence to international regulatory standards make it an ideal destination for companies looking to expand or relocate their medical device manufacturing operations.

Regulatory Bodies Overseeing Medical Device Manufacturing in Mexico

Medical device manufacturing in Mexico is subject to strict regulatory oversight to ensure compliance with international safety, quality, and efficiency standards. Several key organizations govern the industry, providing guidelines, approvals, and certifications that manufacturers must adhere to in order to operate within the country.

1. Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)

COFEPRIS is Mexico’s primary regulatory authority for medical devices. It is responsible for evaluating, approving, and monitoring medical products to ensure they meet safety and efficacy standards. The agency regulates the registration, import, manufacturing, and commercialization of medical devices, ensuring compliance with national health regulations. COFEPRIS also aligns its standards with international agencies like the U.S. FDA and the European Medicines Agency (EMA) to facilitate global trade.

2. Mexican Institute of Industrial Property (IMPI)

IMPI oversees intellectual property protection, including patents, trademarks, and industrial designs related to medical devices. Companies manufacturing in Mexico benefit from strong intellectual property protections, ensuring their innovations are safeguarded from unauthorized use or duplication.

3. General Directorate of Standards (DGN) – Secretariat of Economy

DGN is responsible for developing and enforcing Mexican Official Standards (NOMs) related to medical devices. These standards outline specific technical and safety requirements that manufacturers must follow, ensuring consistency and compliance with global regulatory expectations.

4. National Center for Health Technology Excellence (CENETEC-Salud)

CENETEC supports the development and evaluation of medical technologies in Mexico, providing technical guidance and regulatory recommendations. It collaborates with industry leaders, regulatory bodies, and healthcare institutions to enhance innovation in medical device production.

5. Customs and Trade Authorities (SAT & PROSEC Program)

The Mexican Tax Administration Service (SAT) and the Sectorial Promotion Program (PROSEC) facilitate the import and export of medical devices by reducing tariffs and streamlining trade operations. Companies participating in these programs benefit from lower costs and faster supply chain movement.

These regulatory bodies work together to maintain Mexico’s high manufacturing standards, ensuring that medical device companies comply with safety regulations, protect intellectual property, and gain competitive trade benefits. By adhering to these frameworks, manufacturers in Mexico can confidently produce and export high-quality medical devices to global markets.

Overview of the Medical Device Industry in Mexico

The evolving medical device manufacturing landscape in Mexico presents challenges and opportunities. Addressing the skills gap and advancing the sector are essential for continuous growth, ensuring it meets future demands and takes advantage of new developments.

In navigating Mexico's medical device manufacturing industry, a focused approach is essential for tapping into the sector's vast potential. Shelter services like those offered by American Industries play a vital role in providing comprehensive support such as legal guidance, regulatory compliance, and operational assistance. This partnership model significantly reduces entry barriers and operational risks, smoothing the pathway for expansion and allowing businesses to focus on their primary objectives.

If you're exploring the Mexican medical devices market, contact American Industries for a complimentary business case analysis to learn more about the benefits and investment opportunities Mexico offers.  Learn more about our medical device manufacturing services.