Role of the Importer as Registration Holder
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
Verify all information against official ANVISA sources before making regulatory decisions.
The importer must maintain product liability insurance with minimum coverage typically of R$ 500,000 to R$ 5,000,000 depending on the device class and risk profile. The importer is jointly liable with the foreign manufacturer for adverse events, recalls, and regulatory non-compliance discovered during the device's lifecycle in Brazil.