Medical Device Regulatory Services in LATAM

Medical Device Registration Overview

LATAM promises to be one of the most lucrative markets for Medical device registration for manufacturers. In LATAM, Brazil gets the ‘Most Promising Market’ tag with its growing economy and increasing demand for healthcare products. Other than the high localization of ROI, the Regulatory complexities, and differences in approach among member countries are the biggest bottlenecks for companies seeking to for Medical device registration  in the region. 

Freyr has a significant presence in the LATAM region with a widespread local Medical device Authorized Representative network. We cover the entire spectrum of Regulatory support services for Medical Device clients seeking to market products in this emerging market.

Our Presence


Freyr Expertise

  • Product Classification and Registration services 
  • QMS Compliance strategy 
  • Local representation services
  • Gap Analysis of technical documents & quality systems
  • Regulatory support for product development documents such as, design history files
  • Regulatory support for Technical File Compilation 
  • Regulatory and Market Intelligence support
  • Document and Labeling Translation support
  • Health Agency Liaising and support
Freyr Advantages


Freyr Advantages


Successful submissions for varied class of devices ranging from software to sutures


Local affiliate access to meet challenges of authority and language specific requirements


Dedicated personnel to provide Medical Devices and IVDs


Have successfully delivered device registration projects with utmost customer satisfaction


In-country or Legal representative support with a cost-effective model