Latin America Medical Device Regulatory Affairs Market Size & Outlook

The medical device regulatory affairs market in Latin America is expected to reach a projected revenue of US$ 446.2 million by 2030. A compound annual growth rate of 9.4% is expected of Latin America medical device regulatory affairs market from 2025 to 2030.
Revenue, 2024 (US$M)
$260.7
Forecast, 2030 (US$M)
$446.2
CAGR, 2025 - 2030
9.4%
Report Coverage
Latin America

Latin America medical device regulatory affairs market, 2018-2030 (US$M)

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Latin America medical device regulatory affairs market, 2018-2030 (US$M)

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Latin America medical device regulatory affairs market highlights

  • The Latin America medical device regulatory affairs market generated a revenue of USD 260.7 million in 2024.
  • The market is expected to grow at a CAGR of 9.4% from 2025 to 2030.
  • In terms of segment, outsource was the largest revenue generating service provider in 2024.
  • Outsource is the most lucrative service provider segment registering the fastest growth during the forecast period.
  • Country-wise, Argentina is expected to register the highest CAGR from 2025 to 2030.


Latin America data book summary

Market revenue in 2024USD 260.7 million
Market revenue in 2030USD 446.2 million
Growth rate9.4% (CAGR from 2025 to 2030)
Largest segmentOutsource
Fastest growing segmentOutsource
Historical data covered2018 - 2023
Base year for estimation2024
Forecast period covered2025 - 2030
Quantitative unitsRevenue in USD million
Market segmentationIn-house, Outsource


Other key industry trends

  • In terms of revenue, Latin America region accounted for 3.9% of the global medical device regulatory affairs market in 2024.
  • Globally, Asia Pacific is projected to lead the regional market in terms of revenue in 2030.
  • Asia Pacific is the fastest growing regional market and is projected to reach USD 4,590.5 million by 2030.

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Medical Device Regulatory Affairs Market Scope

Medical device regulatory affairs market segmentation & scope
In-house
Outsource
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Other Services
Diagnostics
Therapeutics

Medical Device Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

Latin America medical device regulatory affairs market outlook

The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to medical device regulatory affairs market will help companies and investors design strategic landscapes.


Outsource was the largest segment with a revenue share of 65.52% in 2024. Horizon Databook has segmented the Latin America medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.


Latin America's medical device regulatory affairs market is growing owing to rise in the number of new entrants venturing into the medical device market in the region. Brazil, Mexico, Colombia, Venezuela, and Argentina are driving the growth of the medical device market in Latin America.

The market is expected to showcase significant growth during the forecast period owing to an increase in the number of medical device companies venturing into this region, which is anticipated to drive the demand for regulatory and quality assurance, thereby contributing to the growth of the medical device regulatory affairs market. In addition, its geographic placement being strategically close to the U.S. market is another factor boosting market growth in this region.

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Horizon Databook provides a detailed overview of continent-level data and insights on the Latin America medical device regulatory affairs market , including forecasts for subscribers. This continent databook contains high-level insights into Latin America medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

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Latin America medical device regulatory affairs market size, by country, 2018-2030 (US$M)

Latin America Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)

Latin America medical device regulatory affairs market size, by country, 2018-2030 (US$M)

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