BRH

A Brazilian Registration Holder (BRH) is a Brazilian legal entity that serves as the local representative for foreign medical device manufacturers seeking to register and sell their products in Brazil. The BRH is legally responsible for the product in the Brazilian market.

Key responsibilities of a BRH:
- Holds the device registration (Cadastro or Registro) with ANVISA
- Serves as the official point of contact with Brazilian authorities
- Responsible for post-market surveillance and vigilance reporting
- Must maintain technical documentation in Brazil
- Handles regulatory submissions and renewals
- Manages product labeling compliance

Requirements for a BRH:
- Must be a legally established Brazilian company
- Must have a Technical Manager (Responsável Técnico) on staff
- Must maintain a valid Operating Authorization from ANVISA
- Should have experience in medical device regulatory affairs

Important considerations:
- The BRH owns the registration, not the foreign manufacturer
- Changing BRH requires transferring or re-registering the product
- Choose a BRH with relevant product experience
- Ensure clear contractual agreements about registration ownership

Difference from distributor: While a BRH can also be a distributor, these are separate roles. Some companies use one entity for both functions, while others separate regulatory (BRH) from commercial (distributor) relationships.