Overcoming Brazil's market entry challenges
The Brazilian Health Regulatory Agency (ANVISA) has made significant strides in aligning its regulatory framework for in vitro diagnostic (IVD) devices with international guidelines. However, the ongoing regulatory changes represent unique challenges for IVD manufacturers, particularly small and mid-sized companies. To succeed in the dynamic Brazilian market, businesses must navigate complex requirements, including Brazil Good Manufacturing Practices (B-GMP) certification, while staying competitive amidst economic and political uncertainties.
The ANVISA regulatory landscape
This whitepaper provides an overview of ANVISA’s regulatory landscape highlighting key developments and offering practical strategies to overcome market entry challenges.
Download our white paper to learn:
The evolution of ANVISA’s Regulatory Framework
Challenges of B-GMP certification
Strategies to reduce market entry barriers
Overview of the IVD regulatory landscape in Brazil: ANVISA’s evolving approach to IVD oversight
1.83 MB
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