Brazil Registration Holder (BRH) & ANVISA Interface

Foreign manufacturers require a legally established Brazilian entity to hold the ANVISA notification or registration and interface with the Agency. The local holder is more than an address: it is central to submissions, changes, importation coordination, post-market reporting, field actions and access to the technical documentation that supports the product.

Discuss Brazil Registration Holder Support

When This Support Is Needed

The foreign manufacturer has no established commercial or legal entity in Brazil

A new Brazilian importer or registration holder is being appointed for market entry

The manufacturer seeks stronger governance over regulatory data, technical files, complaints, and changes

A transfer of registration ownership (transferência de titularidade) or local partner change is being planned

What We Challenge Before Submission

Who legally and commercially owns the master regulatory data and approved Brazilian labeling?

How quickly must the manufacturer notify the holder of design, supplier, manufacturing site, or software changes?

Can the holder independently access investigation and safety information when ANVISA requests it during an audit?

Are complaint, tecnovigilância, and field-action responsibilities contractually and operationally clear?

Does the holder legal identity match the Portuguese labeling, packaging artwork, and ANVISA database records?

Our BRH Support Includes

Brazilian Registration Holder (BRH) readiness assessment and legal qualification

Manufacturer-Holder Quality and Regulatory Interface Agreement drafting

Legal authorization documentation, consularization/apostille, and Power of Attorney (Procuração) coordination

Company Operating Authorization (AFE) and activity-scope alignment checks with ANVISA

Submission, petition, and variation communication pathway governance

Technical documentation and dossier access protocol establishment

Complaint, adverse-event, and tecnovigilância escalation workflows

Field-action, safety alert, and recall communication pathways under ANVISA rules

Lifecycle change-notification governance between manufacturer and Brazilian holder

Import, customs clearance, and distribution regulatory interface support

Regulatory Governance Model:

We establish a governance model between the manufacturer and the Brazilian holder. The key question is not only who submits the dossier, but whether the holder can access the information and decisions needed to meet ANVISA obligations throughout the lifecycle.

Establish Independent Brazil Registration Holder Governance

Our Brazilian regulatory consultants coordinate local representative agreements, maintain AFE alignments, and manage ANVISA communications.

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