BRH (Brazilian Registration Holder) is eine brasilianische juristische Person, die erforderlich ist, um Medizinprodukteregistrierungen im Namen ausländischer Hersteller bei ANVISA zu halten.
Complete Guide to 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.
Related Terms
More Local Representatives
View allEine von Nicht-EU-Herstellern benannte juristische Person, die in ihrem Namen für die Einhaltung der EU-MDR handelt und als Kontaktstelle zu den Regulierungsbehörden dient.
Eine Einheit in der Lieferkette, die Medizinprodukte auf dem Markt bereitstellt, ohne deren Zweckbestimmung zu ändern.
Eine in der Europäischen Union ansässige juristische Person, die von einem Nicht-EU-Hersteller beauftragt wird, in regulatorischen Angelegenheiten gemäß EU-MDR in seinem Namen zu handeln.
Jede natürliche oder juristische Person in der Medizinprodukte-Lieferkette, die an der Bereitstellung von Produkten auf dem Markt beteiligt ist, einschließlich Hersteller, Bevollmächtigte, Importeure und Händler.
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