Brazil's INMETRO Certification: A Guide for Korean Electro-Medical Device Manufacturers

Medical Device Global Market Access · Jan 13, 2026 · 3m

This episode focuses on a critical regulatory hurdle for Korean medical device companies entering the Brazilian market: the mandatory INMETRO certification for electro-medical devices. We break down why this certification, which requires local testing in Brazil, is often an unexpected challenge for manufacturers accustomed to the MFDS system. We cover the specific devices affected, the typical timelines of three to twelve months, and the ongoing costs associated with maintenance audits, providing a clear overview of this significant market access barrier. Key Questions: - What is INMETRO…