Your Brazil Registration Holder for ANVISA Market Access
HSC Global acts as your independent Brazil Registration Holder (BRH), managing ANVISA registration for foreign manufacturers of medical devices and pharmaceuticals. You keep full ownership and control of your registrations. We handle the regulatory complexity.
Foreign Manufacturers Cannot Register Products Directly with ANVISA
Brazilian regulation requires that every medical device or pharmaceutical product registered with ANVISA be held by a company legally established in Brazil. If you manufacture outside Brazil, you need a local entity to act as your Brazil Registration Holder.
You have two options: register through your distributor, or appoint an independent BRH like HSC Global.
Whoever holds the registration controls your market
When your distributor holds your registration, they control your market access. Changing distributors means starting the registration process over, losing months or years of commercial presence.
Neutral registration, negotiate from strength
With HSC Global as your independent BRH, your registration stays neutral. You can work with multiple distributors, switch commercial partners freely, and negotiate from a position of strength.
Complete ANVISA registration and ongoing regulatory ownership. We manage the full lifecycle of your product in Brazil.
Regulatory Strategy and Classification. We define the correct regulatory pathway for your product under ANVISA rules, including risk classification, applicable RDCs, and registration route (Notificacao, Cadastro, or Registro).
ANVISA Registration Submission. We prepare, compile, and submit your complete technical dossier in Portuguese, manage all communications with ANVISA, and respond to technical demands (exigencias) until approval.
INMETRO Certification and BGMP. Where applicable, we coordinate INMETRO certification for electromedical devices and support Brazilian Good Manufacturing Practices (BGMP) certification for your manufacturing sites.
Import and Distribution Support. As the legal importer of record, we enable your products to enter Brazil and reach any distributor you choose.
Post-Market and Lifecycle Management. We manage registration renewals, variations, labelling updates, technovigilance reporting, and ongoing compliance so your products stay on the market without interruption.
A Regulatory Partner, Not Just a Legal Address
From First Contact to Market in Four Steps
Regulatory Assessment
We review your product portfolio, classify each product under ANVISA rules, and map the fastest viable registration pathway.
BRH Agreement
We formalise the Brazil Registration Holder agreement with clear terms protecting your ownership and transfer rights.
Dossier and Submission
We build your technical dossier, translate and adapt documentation, and submit to ANVISA, managing every interaction until approval.
Market Entry and Maintenance
Your product enters Brazil through our import structure. We maintain the registration and keep you compliant for as long as you sell in the market.
Beyond Registration: A Logistics Operation Built for Brazil
Getting ANVISA approval is only half the journey. Medical device and pharmaceutical logistics in Brazil demand far more than warehousing and transportation: regulatory compliance, traceability, temperature control, and specialised partners are mandatory to preserve product integrity and meet market requirements. HSC Global designs customised logistics projects for foreign manufacturers entering Brazil, and connects you to the most suitable logistics operator to execute them.
The result: a complete, implementation-ready logistics project paired with the ideal partner - reducing risks, optimising costs, and accelerating your market entry.
Frequently asked questions
Enter the Brazilian Market with Confidence
Brazil is the largest healthcare market in Latin America. The only thing between your product and 200+ million patients is the right regulatory partner.
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