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Role of the Importer as Registration Holder

BR-unique

In Brazil, the importer typically holds the medical device registration (Registro/Cadastro/Notificação) in their own name — not the foreign manufacturer. This makes the Brazilian importer the legal registration holder and fully responsible for the product's compliance throughout its lifecycle in Brazil.

This is a fundamental difference from the EU (where the manufacturer holds the CE certificate), the US (where the foreign manufacturer registers directly with FDA via a US agent), Australia (where the sponsor holds the ARTG registration), and most other major markets.

What this means in practice​

As the registration holder, the Brazilian importer must:

  • Hold all product registrations in their own name and CNPJ;
  • Ensure the foreign manufacturer maintains GMP compliance (CBPF or equivalent);
  • Submit all post-registration change petitions and renewals;
  • Report all adverse events via NOTIVISA;
  • Manage all recalls on behalf of the foreign manufacturer in Brazil;
  • Maintain adequate product liability insurance; and
  • Be the primary point of contact for ANVISA in all regulatory matters.

This gives the Brazilian importer significant leverage in negotiations with foreign manufacturers — and significant liability if something goes wrong.

Official resources​

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.