Brazil Registration Holder: How Foreign Manufacturers Sell Medical Devices in Brazil Without a Local Entity

Brazil is the largest medical device market in Latin America, and one of the most demanding from a regulatory standpoint. For many international manufacturers, the first barrier appears before any technical documentation is even discussed: ANVISA does not accept registrations under a foreign company's name.

This means that without a legal entity in Brazil, there is no registration. And without a registration, there is no importation and no sales.

The good news: there is a well established model that solves exactly this problem, the Brazil Registration Holder.

What ANVISA requires from a registration applicant

To register a medical device in Brazil, the applicant company must:

• Be a legally established entity in Brazil with an active tax ID (CNPJ).
• Hold a Company Operating Authorization (AFE) issued by ANVISA covering importation and distribution activities.
• Maintain a qualified Technical Responsible professional.
• Comply with the applicable Good Storage and Distribution Practices.

None of these requirements can be met directly by a company based abroad. The obvious alternative would be opening a Brazilian subsidiary, but that involves significant costs, administrative structure, tax obligations, and a timeline that easily exceeds several months before the first operation.

For most manufacturers testing the Brazilian market, that investment is hard to justify at the market entry stage.

What a Brazil Registration Holder is

The Brazil Registration Holder (BRH), also known as the Registration Holder or local registration holder, is a Brazilian company duly licensed by ANVISA that registers the foreign manufacturer's product under its own name, assuming local regulatory responsibility.

In practice, the BRH acts as the manufacturer's regulatory representative in Brazil. It conducts the registration process, answers to ANVISA, keeps documentation up to date, and performs post-market surveillance obligations such as adverse event reporting and recalls.

The manufacturer keeps full intellectual property ownership and full control of the commercial strategy. Manufacturing stays in the country of origin, and distributor relationships are defined by the manufacturer itself.

How the operation works in practice

A typical market entry flow through a BRH follows these steps:

1. Regulatory classification. The BRH assesses the product's risk classification under RDC 751/2022 and defines the applicable pathway: notification for Class I and II or registration for Class III and IV.

2. Dossier preparation. The manufacturer's technical documentation is adapted to ANVISA requirements, including translations, Portuguese labeling, and instructions for use.

3. Submission and follow-up. The BRH files the application and manages any deficiency letters until the registration or notification is published.

4. Importation and distribution. Once the registration is published under the BRH's name, importation becomes possible. The manufacturer can operate with one or several authorized distributors.

5. Regulatory maintenance. The BRH handles renewals, registration amendments, and technovigilance obligations throughout the product's entire lifecycle in the market.

The most expensive mistake: letting your distributor hold the registration

This is the point that separates a well structured market entry strategy from a future problem.

In Brazil, the registration belongs to whoever holds it, not to the manufacturer. If the commercial distributor is also the registration holder, that distributor controls the manufacturer's access to the Brazilian market.

If the commercial relationship deteriorates, the manufacturer cannot simply switch distributors. The registration stays with the previous company, and transferring it depends on that company's agreement. Without an agreement, the only path is starting a brand new registration process from scratch, which can mean 12 to 24 months out of the market, plus the cost of a new dossier.

This scenario is more common than it looks, and it is the main reason experienced manufacturers choose an independent, neutral BRH with no commercial interest in distribution.

The advantages of an independent BRH

With an independent registration holder, the manufacturer:

• Switches distributors at any time without losing the registration.
• Works with multiple distributors simultaneously, segmented by region or channel.
• Keeps full control over pricing and positioning strategy.
• Reduces dependence on a single commercial partner.
• Preserves regulatory continuity even when the commercial operation changes.

What to evaluate before choosing a BRH

Not every company holding an AFE is prepared to act as a professional registration holder. Before signing, verify:

• Complete licensing. A valid AFE compatible with your product's risk class.
• Regulatory experience. A track record of registrations in your product category and familiarity with ANVISA requirements.
• Post-market structure. Established processes for technovigilance, complaint handling, and recall management.
• Contractual transparency. Clear clauses on registration transfer in case the manufacturer decides to change holders in the future.
• Commercial independence. No conflict of interest with the distribution of your products.

Conclusion

The Brazil Registration Holder model lets foreign manufacturers access the Brazilian medical device market with lower investment, shorter timelines, and full strategic control. Choosing the right holder, however, determines whether the registration becomes an asset of the manufacturer or a vulnerability in someone else's hands.

---

HSC Global Group acts as Brazil Registration Holder for international manufacturers, providing registration, importation, and ongoing regulatory compliance with no local entity required. Talk to our team and structure your entry into the Brazilian market with confidence.