BRH Representation: your registration holder in Brazil.

Overseas manufacturers need an authorised Brazilian company to hold their registration (BRH - Brazil Registration Holder) to access the market. We provide this regulatory representation with independence and technical responsibility.

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BRH Representation: your registration holder in Brazil.
What we deliver

We provide your local regulatory infrastructure, without the need to open a Brazilian subsidiary.

  1. Acting as registration holder (BRH) before ANVISA.

  2. Maintaining AFE and the authorisations required for regulatory importation.

  3. Managing the registration lifecycle (submissions, changes and renewals).

  4. Official liaison with ANVISA and a medical device vigilance contact in Brazil.

  5. Confidentiality and independence from distributors.

Deliverables

What you receive

A BRH representation agreement with defined responsibilities.
Registrations maintained in the Brazilian holder's name.
A local regulatory contact for ANVISA and the market.
Periodic regulatory status reports to the manufacturer.
References

Reference standards

  • ANVISA requirements for the national registration holder.
  • RDC 751/2022 (market authorisation) and regulatory importation requirements.
FAQ

Frequently asked questions

Let's talk

Are you a manufacturer based outside Brazil?

We can be your local registration holder with complete independence.

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