Brazilian Registration Holder (BRH)
Under ANVISA rules (RDC 751/2022 and related), foreign manufacturers must appoint a Brazilian Registration Holder (Detentor de Registro / BRH). We provide compliant BRH services — registration, import compliance and post-market maintenance.
Why Do You Need a Brazilian Registration Holder?
Brazil's medical device market is regulated by ANVISA (Agência Nacional de Vigilância Sanitária). Foreign manufacturers cannot apply to ANVISA directly — they must act through a Brazilian Registration Holder (BRH) established in Brazil for registration and post-market maintenance.
The BRH is the legal holder of the registration certificate, responsible for registration maintenance, change management, import compliance and vigilance reporting. Devices follow either the Cadastro (lower risk classes) or Registro (higher risk classes) route; registration files must be submitted in Portuguese, and Portuguese labelling and instructions are mandatory.
- Applies to all foreign medical device and IVD manufacturers
- The registration is bound to the BRH — changing holders means a registration transfer
- Labels, instructions and registration files must be in Portuguese
Regulatory Basis
Our BRH services follow the current ANVISA regulatory framework.
Medical Device Regularization
Sets the registration routes for medical devices and IVDs: Cadastro (notification) for lower risk classes, Registro (technical review) for higher risk classes.
Brazilian Good Manufacturing Practices
ANVISA requires Brazilian GMP (BGMP) certification for applicable devices, which may include on-site audits of the foreign plant and certificate maintenance.
Post-Market Vigilance
Adverse events and field safety corrective actions must be reported to ANVISA through the BRH and recorded in the quality system.
Import & Commercialization
The BRH carries import-compliance duties: import licence support, distributor coordination and registration-data consistency management.
Our Services
Full-lifecycle BRH coverage, from route assessment to ongoing post-market maintenance.
BRH Registration Holder Service
Signed BRH agreement performing the statutory holder duties: registration maintenance, change management and ANVISA communication.
ANVISA Registration Assistance
Prepare Cadastro/Registro dossiers, organise Portuguese documents, file with ANVISA and track the review progress.
Brazilian GMP Support
BGMP certification applications, preparation for on-site audits of foreign plants and audit accompaniment.
Import & Customs Compliance
Import licence support, distributor coordination and registration/import data consistency management.
Portuguese Label & IFU Review
Review Portuguese labels, instructions and UDI-related requirements — compliant with ANVISA labelling rules before market placement.
Vigilance & Incident Reporting
Help determine reportable events, file vigilance reports with ANVISA through the BRH, and coordinate field safety corrective actions.
Change & Renewal Management
Registration changes, renewal applications and ANVISA fee management — keeping registrations from lapsing.
Ongoing Compliance Maintenance
ANVISA regulatory tracking, annual compliance review and support for new product registrations.
Our Process
A clear, predictable process — route assessment starts right after signing.
Needs Assessment
Confirm the risk class and registration route (Cadastro / Registro) with applicable requirements.
Agreement
Sign the BRH agreement with the authorized products and both parties' duties.
Registration Filing
Organise the Portuguese dossier, file with ANVISA and track the review.
Import & Launch
Complete label review and import arrangements; products enter the Brazilian market.
Ongoing Maintenance
Vigilance reporting, change management, renewals and annual compliance review.
Our Advantages
Local Brazilian Registration Holder
A compliant Brazilian entity performing the BRH duties — with local registration-maintenance and ANVISA communication capability.
Bilingual, Zero Time-Zone Friction
Direct communication with our Shenzhen-based team; Brazilian partners handle local matters. Portuguese files and ANVISA correspondence fully supported.
Multi-Market Bundling
EC-REP, US Agent and BRH under one roof — registration data and labelling requirements managed consistently, no duplicated onboarding.
Frequently Asked Questions
Who must appoint a BRH?
All manufacturers outside Brazil planning to sell medical devices or IVDs in Brazil must complete ANVISA registration through a Brazilian Registration Holder (BRH) established in Brazil.
How is a BRH different from an importer?
The BRH is the legal holder of the registration — responsible for registration maintenance, changes and ANVISA communication. The importer is the commercial import role. The duties differ and may be held by the same or different entities; the agreement should define the division clearly.
What is the difference between Cadastro and Registro?
Lower-risk-class devices follow Cadastro (a notification-based route with a faster process); higher-risk classes follow Registro (ANVISA technical review with a longer timeline). The applicable route follows ANVISA's risk classification — we confirm it during assessment.
Must labels and instructions be in Portuguese?
Yes. Portuguese labelling and instructions are mandatory for the Brazilian market, and registration files are also submitted in Portuguese. We organise Portuguese files and review labels for you.
Is Brazilian GMP (BGMP) certification required?
For applicable devices, ANVISA requires Brazilian GMP (BGMP) certification, which may include on-site audits of the foreign plant. We assist with certification applications, audit preparation and accompaniment.
What happens when I change the BRH?
The registration is bound to the BRH; changing holders involves a registration-transfer procedure and ANVISA approval, with real timelines and risks. Choose a long-term, reliable partner from the start.
How are the fees calculated?
Fees typically comprise a contracting assessment fee, a registration service fee and an annual maintenance fee, determined by the number of products and risk classes (ANVISA official fees are charged separately per the current schedule). Submit your product information via the contact page and we will quote within 24 hours.
Ready for the Brazilian market?
Submit your product information — receive a BRH proposal and quote within 24 hours.