Sobel Consult’s Independent Brazilian Registration Holder Service

Your device is ready for Brazil. You may already have a distributor, or several candidates. But before ANVISA accepts your submission, you need a local company to hold the registration. That choice will follow your product for as long as it is on the Brazilian market.

When manufacturers consider Sobel Consult for their Brazilian Registration Holder, the question we hear most is simple: if the registration holder does not import, who brings the product into Brazil?

The short answer: With Sobel Consult’s Brazilian Registration Holder service, you maintain your ANVISA registration independently of any distributor. The importer of record is the company you choose and authorise, and you can authorise more than one. Because your registration remains independent of any commercial partner, you retain full control over who sells your device.

This article explains how this model works in practice, why we built it this way and when it is the right choice for your company.

At a glance

How does Sobel Consult’s Brazilian Registration Holder service work?

Foreign manufacturers cannot hold an ANVISA registration in their own name. Under RDC 751/2022, a company established in Brazil must hold the registration or notification of a medical device. That company is the Brazilian Registration Holder, often called BRH, detentor do registro or titular.

With Sobel Consult, you sign one contract and work with one team. The registration is held by Sobel’s partner in Brazil, that acts only as registration holder. Sobel manages the rest of the process:

1. Holder designation. We arrange the formal designation of the registration holder for your device.
2. Submission and communication with ANVISA. We prepare the notification or registration dossier and manage all follow-up with the agency.
3. Vigilance and post-market duties. We manage technovigilance, complaints and field actions together with your team.
4. Lifecycle maintenance. We keep the registration active and aligned with ANVISA requirements, including changes and renewals, for as long as you wish.
5. Importer and distributor qualification. We check that the companies you choose to import and distribute your device meet ANVISA requirements before they are authorised.

The last point is important. As we explain below, it is what allows you to work with the commercial partners of your choice while the regulatory responsibility stays clear. You can read more about the service on our Brazilian Registration Holder page.

Why an independent holder, not an importer, protects your registration

In Brazil, the registration holder can also be the importer and the distributor. Many manufacturers start this way, because one partner seems simpler. The risk appears later.

When your distributor holds the registration, your market access depends on that commercial relationship. If sales fall short, if the partner changes its strategy or if you want a second distributor in another region, the registration is in the hands of the company you need to negotiate with. In our experience, this is one of the most common reasons why manufacturers lose time in Brazil after the registration is already approved.

An independent BRH separates the two roles:

• The regulatory role stays with the independent holder and Sobel: the registration, ANVISA communication, vigilance and lifecycle maintenance.
• The commercial role stays with the companies you choose: import, logistics, sales and customer relationships.

This is why neither Sobel nor the holder imports or distributes your device. It is a deliberate choice, not a gap. A holder with no commercial interest in your product has no reason to keep your registration from another importer, to favour one distributor over another or to use the registration in a negotiation.

The independent model is not the only valid option. If you want one company to hold the registration and import the product, and you are comfortable with that dependency, a combined holder and importer can work. The point is to choose consciously, before the registration is filed, because changing the holder later always takes more effort than choosing well at the start.

How do importers work under your ANVISA registration?

The importer of record does not need to be the registration holder. RDC 81/2008, the ANVISA resolution on the import of regulated products, allows a third company to import a registered device when two conditions are met:

• the importer has an operating licence from ANVISA (Autorização de Funcionamento, AFE) that covers the import of medical devices; and
• the registration holder issues a declaration authorising that company to import the product (Declaração do Detentor da Regularização do Produto Autorizando a Importação por Terceiro).

The declaration is linked to the registration number. If you want to work with two or three importers, for example one per region or one per customer segment, each of them receives its own authorisation under the same registration.

There is one point manufacturers should know. In Sobel’s regulatory interpretation, the holder remains accountable for the products imported under its registration. For this reason, Sobel qualifies each importer before the declaration is issued and keeps the authorisations up to date. This protects you, the importer and the registration.

Is this you?

• Does your current contract say what happens to the registration if the distributor partnership ends?
• Do you plan to sell in Brazil through more than one importer or distributor, now or in the next few years?
• Has a Brazilian distributor offered to register your device in its own name?

If any of these questions is hard to answer, it is worth defining the holder and importer roles before your next step.

Can you change distributors or your BRH without losing the registration?

Changing or adding distributors: yes. With an independent holder, the registration stays where it is. Sobel qualifies the new importer and arranges the new authorisation and, where needed, the withdrawal of the old one. Your registration number, your technical file and your vigilance history do not change.

Changing your BRH: this is also possible, but it requires regulatory updates with ANVISA, and the steps depend on the type of regularisation and on the cooperation of the current holder. This is exactly why the choice of holder matters so much at the start. Whoever you appoint, make sure the BRH contract describes how the registration will be handed over if the relationship ends.

In practice: A European manufacturer of Class II orthopaedic instruments enters Brazil with a distributor based in São Paulo. Through Sobel’s service, the registration is held independently, and this distributor is authorised as importer. Two years later, the manufacturer wants a second partner to serve hospitals in the South of the country. Sobel qualifies the new company, and a second import authorisation is issued under the same registration. The first distributor continues to operate. No new registration is needed, and the manufacturer does not have to renegotiate its market access with anyone.

The same scenario with a distributor as registration holder would look very different. The second partner would need the agreement of the first, which is also a competitor.

Does Sobel Consult only work in Brazil?

No. Brazil is where Sobel is based, but it is not the only market we cover. Sobel Consult supports medical device, IVD and cosmetics manufacturers in Brazil, the European Union, the United Kingdom, the United States and Canada. In the EU, for example, we act as Authorised Representative for manufacturers outside the Union and support the full EUDAMED process, as described in our article on the EUDAMED deadline.

For a manufacturer, this has three practical advantages:

• One regulatory strategy. Your technical documentation, risk management and biological evaluation can be planned once and adapted to each market, instead of being rebuilt by a different provider in each country.
• Consistent post-market data. Complaints and vigilance events from different markets reach one team, which makes trends easier to detect and report.
• Clear sequencing. We help you decide which market to enter first, based on your certificates, your evidence and your commercial plan.

In Brazil, the BRH service is available with or without INMETRO, depending on whether your device falls under INMETRO certification. Where needed, we also coordinate INMETRO and ANATEL certification and the ANVISA registration or notification itself. Our team works in Portuguese, English and German, and Sobel was recognised as a Top Medical Device Regulatory Consultant in Latin America 2025 by Healthcare Business Review.

How to choose your Brazilian Registration Holder in 4 steps

1. First, decide whether you want the regulatory and commercial roles in one company or in two.
2. Next, list the importers and distributors you plan to work with now and in the next three years.
3. Then, check whether your device falls under INMETRO or ANATEL certification.
4. Finally, review the BRH contract: who holds the registration, whether that company also sells medical devices, how importers are authorised and how a change of holder would work.

How Sobel can help

Sobel Consult provides an end-to-end Brazilian Registration Holder service for foreign manufacturers. Your registration is held independently of any distributor, and we manage the submission, ANVISA communication, vigilance and the qualification of the importers you choose. If your plan includes other markets, the same team can support you in the EU, the UK, the US and Canada.

If you are deciding who will hold your registration in Brazil, we would be glad to talk. Get in touch with us.

Frequently asked questions

Is Sobel Consult an importer in Brazil?

No. Sobel Consult provides a Brazilian Registration Holder service in which neither Sobel nor the holder imports or sells your device. Importation is done by companies you choose, authorised under your ANVISA registration.

Who holds my ANVISA registration with Sobel Consult?

The registration is held by Sobel’s partner in Brazil, that acts only as registration holder. Your contract and day-to-day contact are with Sobel, which manages the service from start to finish.

Can more than one company import my device under one ANVISA registration?

Yes. Each importer needs an AFE that covers the import of medical devices and a declaration from the registration holder authorising the import, as provided in RDC 81/2008.

Can I change my distributor without losing my registration?

Yes. With an independent holder, the registration is not linked to the distributor. A new importer can be authorised, and the old authorisation withdrawn, under the same registration.

Can I change my Brazilian Registration Holder later?

Yes, but it requires regulatory updates with ANVISA, and the steps depend on your case. For this reason, it is better to choose the holder carefully before the first submission.

Does Sobel Consult only work in Brazil?

No. Sobel Consult supports manufacturers in Brazil, the European Union, the United Kingdom, the United States and Canada.

Can a foreign manufacturer hold its own ANVISA registration?

No. The registration must be held by a company established in Brazil, which acts as the Brazilian Registration Holder.

Official sources

• RDC 751/2022: classification and registration of medical devices (AnvisaLegis)
• RDC 81/2008: import of goods and products subject to health surveillance (ANVISA)

This article is for information only. It does not replace an assessment of your specific device and regulatory situation.