Brazil's ANVISA: The Portuguese Language Barrier for Korean MedTech

Medical Device Global Market Access · Jan 11, 2026 · 2m

This episode details the single most critical challenge for Korean medical device manufacturers entering Brazil: ANVISA's strict Portuguese-only documentation requirement. We explore why this is a major hurdle, how it differs from Korea's MFDS policies, and the significant risks of improper translation, including costly delays and registration failures. Key Questions: - Why is entering the Brazilian market uniquely challenging for Korean medical device companies? - What is ANVISA's strictest documentation requirement for all submissions? - How does Brazil's language policy for medical devices…