Korean MedTech in Brazil: Unlocking ANVISA Approval with a Brazilian Registration Holder (BRH)

Medical Device Global Market Access · Jan 9, 2026 · 2m

This episode explores the single most critical regulatory requirement for Korean medical device companies entering the Brazilian market: the mandatory appointment of a Brazilian Registration Holder (BRH). We delve into why foreign companies cannot register directly with ANVISA, contrast Brazil's system with Korea's MFDS, and outline the extensive legal and operational responsibilities of a BRH, from registration and GMP inspections to post-market surveillance. Learn why selecting the right local partner is essential for your success in Brazil. Key Questions: - What is a Brazilian Registration…