Latin America (LATAM) promises to be one of the most lucrative markets for clients in the medical device industry. In the LATAM, Brazil gets the 'Most Promising Market’ tag with the growing economy and increasing demand for healthcare products. Other than the high localization of Return on Investment (ROI), the Regulatory complexities and differences in approach among member countries are the biggest bottleneck for companies seeking to do business in the region.
Freyr has a significant presence in the LATAM region with a widespread local affiliates network. We cover the entire spectrum of Regulatory support services for medical device clients seeking to market products in this emerging market.
- Product classification and registration services
- Quality Management System (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
- 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
- In-country or legal representative support with a cost effective model