Brazil Medical Device Regulatory Affairs Market Size & Outlook
Brazil medical device regulatory affairs market, 2018-2030 (US$M)
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Brazil medical device regulatory affairs market highlights
- The Brazil medical device regulatory affairs market generated a revenue of USD 109.0 million in 2024 and is expected to reach USD 187.2 million by 2030.
- The Brazil 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.
Medical device regulatory affairs market data book summary
| Market revenue in 2024 | USD 109.0 million |
| Market revenue in 2030 | USD 187.2 million |
| Growth rate | 9.4% (CAGR from 2025 to 2030) |
| Largest segment | Outsource |
| Fastest growing segment | Outsource |
| Historical data | 2018 - 2023 |
| Base year | 2024 |
| Forecast period | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | In-house, Outsource |
Other key industry trends
- In terms of revenue, Brazil accounted for 1.6% of the global medical device regulatory affairs market in 2024.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
- In Latin America, Brazil medical device regulatory affairs market is projected to lead the regional market in terms of revenue in 2030.
- Argentina is the fastest growing regional market in Latin America and is projected to reach USD 67.9 million by 2030.
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Medical Device Regulatory Affairs Market Scope
Medical Device Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
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Brazil 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 65.6% in 2024. Horizon Databook has segmented the Brazil medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
Brazil is the largest medical device market in Latin America and the country is expected to dominate the medical device regulatory affairs market during the forecast period. Brazil is expected to be the target market for international medical device companies, thereby contributing to the demand for regulatory services during the forecast period.
Brazil’s National Health Surveillance Agency has included regulatory requirements that manufacturing services companies must attain a license as a medical manufacturing unit to maintain quality, safety, and performance parameters. This has made Brazil one of the favorable markets for various foreign manufacturers.
In addition, the growing demand for medical device outsourcing and presence of a stable regulatory system are expected to boost the growth of the region. Brazil follows a four-tier and risk-based classification system. Accurate classification of a product is essential to determine the proper ANVISA regulatory pathway, thereby providing a clear & systematic procedure for outsourcing partners.
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Our clientele includes a mix of medical device regulatory affairs market companies, investment firms, advisory firms & academic institutions.
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Horizon Databook provides a detailed overview of country-level data and insights on the Brazil medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into Brazil medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Brazil medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)
Brazil Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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