The Total Value of Medical Device and In-Vitro Diagnostic (IVD) Imports to Mexico Surged From $6.86 Billion in 2021 to $11.40 Billion in 2024, Marking a 12.6% Increase in The Final Year Alone

JERSEY CITY, N.J., Aug. 14, 2025 /PRNewswire/ -- According to the latest study from Pure Global, Mexico's Medical Device Import Market: A Data-Driven Analysis of Market Size, Key Segments, and Competitive Dynamics (2021-2024), Mexico's medical device and in-vitro diagnostic (IVD) import market is a dynamic and rapidly expanding landscape, presenting both significant opportunities and complex challenges for global manufacturers. Import data from 2021 to 2024 reveals a market characterized by robust overall growth, shifting competitive dynamics among global trade partners, and transformative regulatory reforms.

Competitive Landscape: A Shifting Global Balance

The competitive environment is defined by the enduring dominance of the United States, which remains the principal supplier to Mexico. In 2024, U.S. imports were valued at $5.78 billion, accounting for a 50.7% market share.

The primary challenger is Greater China (including the Mainland, Hong Kong, Macau, and Taiwan), as the second-largest supplier. In 2024, imports from this region reached $1.63 billion, capturing a 14.3% market share on the back of impressive 26.8% year-over-year growth.

European nations, particularly Germany and Italy, are also making significant gains. Germany, the third-largest partner, commanded a 7.9% market share in 2024 with imports of $898.2 million, following a massive 94.2% value surge in 2023. Italy has emerged as a particularly aggressive competitor, with its exports to Mexico growing by an explosive 70.9% in 2024 to reach $455.5 million.

Medical Specialty Segments: Key Growth Engines

The General & Plastic Surgery category is the undisputed foundation of the market, with imports reaching a staggering $5.19 billion in 2024 and showing steady 16.3% growth.

Beyond this core segment, several high-technology specialties are experiencing explosive growth:

• Ophthalmic Devices: This market saw imports accelerate dramatically, growing 49.0% in 2024 to reach $1.14 billion. This is fueled by an aging population, a high prevalence of diabetes-related eye conditions, and strong demand from medical tourists.
  
  
• Ear, Nose, & Throat (ENT) Devices: This segment has been a star performer, with import values surging 197.7% in 2023 and another 44.5% in 2024. This reflects rapid technological adoption in a specialized field.
  
  
• Radiology: Driven by a major public and private sector push to modernize healthcare infrastructure, imports in this category jumped 91.2% in 2023 to nearly $900 million.

Regulatory Modernization and Strategic Imperatives

Underpinning these market trends is a landmark regulatory transformation by Mexico's health authority, COFEPRIS. The most impactful change is the new COFEPRIS 2025 Abbreviated Regulatory Pathway, which will fast-track approvals for devices already cleared by major international bodies part of the IMDRF (Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, the United Kingdom, and the United States) or MDSAP (Australia, Brazil, Canada, Japan, and the United States) member states.

Report Q&A

Here are three key questions the report answers:

1. Who is the largest supplier of medical devices to Mexico by a significant margin?

• • Answer: The United States is the largest supplier, holding a 50.7% share of the import market in 2024.

2. Which specific medical specialty represents the largest segment of the import market?

• • Answer: General & Plastic Surgery is the largest segment by far, with imports valued at $5.19 billion in 2024.

3. Which high-tech specialty has shown the most dramatic growth acceleration in the most recent year?

• • Answer: Ophthalmic devices, which saw import growth accelerate to 49.0% in 2024, reaching a value of $1.14 billion.

Interesting Facts from the Report

1. The "Maquiladora Paradox": Mexico is a top-10 global exporter of medical devices, producing sophisticated products for the world. Yet, it simultaneously relies on imports for over 80% of the devices used in its own domestic healthcare system.
   
   
2. Extreme Tender-Driven Volatility: The market for Clinical Chemistry devices experienced an unprecedented value swing, dropping 94% in 2022 and then surging by 2,696% in 2023.
   
   
3. The Rise of ENT: While larger categories grew steadily, the specialized market for Ear, Nose, & Throat (ENT) devices experienced explosive growth, more than quadrupling in value from $68.5 million in 2022 to $294.9 million in 2024.

Download the FULL copy of this research report directly from Pure Global.

About Pure Global

Pure Global is the world's leading MedTech service provider for local representation and registration services, operating at the intersection of regulatory technology (RegTech), artificial intelligence (AI), and market intelligence. We streamline global access through representation and registration in over 30 markets, but our value extends to strategic growth. Every client benefit from exclusive market research reports, developed by ex-Wall Street analysts, that deliver actionable insights into the latest industry trends. This unique combination of regulatory and market expertise gives our clients an unparalleled advantage to succeed and lead in the MedTech space.

Contact

Pure Global
DJ Fang, Head of Global Market Research
[email protected]
For U.S.A. / Canada Call +1-888-768-1688

SOURCE Pure Global