Big opportunities come with complex regulations. But entering Brazil’s medical device market shouldn’t have to be complicated.
Foreign manufacturers need a legally established Brazilian Registration Holder to obtain and maintain ANVISA market authorizations. That’s where your journey into Brazil starts with MEDAGENT.
As your trusted local partner, we bridge the gap between international manufacturers and Brazilian regulatory authorities. From preparing documentation and managing ANVISA submissions to supporting ongoing compliance, we help you navigate the regulatory requirements with confidence.
What is a Brazilian Registration Holder?
The Brazilian Registration Holder is a legally established entity responsible for maintaining medical device authorizations with the Brazilian Health Regulatory Agency Agência Nacional de Vigilância Sanitária (ANVISA) and fulfilling applicable regulatory obligations throughout the product lifecycle.
Your regulatory pathway depends on the device’s intended purpose, risk classification, and applicable requirements under ANVISA RDC 751/2022. Class I and II devices generally follow the Notificação pathway, while Class III and IV devices require Registro. Depending on the product, additional requirements may include Brazilian Good Manufacturing Practices (BGMP) certification, INMETRO certification, and specific technical documentation.
The BRH also manages applicable post-market obligations, including regulatory amendments, vigilance reporting, and registration renewals where required.
