Three holder structures for a Brazilian registration

1. Key takeaways

Brazilian law requires only that the holder be a legal entity established in Brazil; using a subsidiary, a distributor or an independent third party is a business choice, not a legal requirement. The three structures differ in control, cost of exit and transferability, and the transfer window is only 180 days. The price of choosing the wrong structure usually appears at the moment of changing channels, when it is already too late to change it cheaply. In GRZAN’s experience, the structure question is settled in a spreadsheet rather than in a regulation. GRZAN therefore treats structure selection as a project decision with its own analysis, not as a formality settled by whichever partner shows up first.

2. Legal basis

• Classification, Notification and Registration of Medical Devices and the Requirements for Labels and Instructions for Use — RDC No. 751/2022, resolution of September 15, 2022, in force as of March 1, 2023; Article 4, item VIII, Articles 6, 7 and 11
• Transfer of ownership and cancellation of product registrations — RDC No. 903/2024, adopted on September 6, 2024, published in the DOU on September 9, 2024; Articles 6, 26, 28 and 29 [practical estimate, subject to what ANVISA publishes]
• Operating conditions for companies subject to health licensing — Decreto No. 8.077/2013, of August 14, 2013; Article 2 and Article 3

3. Expert insights

The GRZAN view: the three structures do not differ in compliance threshold; they differ in whether the registration and the goods are tied to the same hand. A wholly owned subsidiary gives the strongest control, at the highest set-up cost and lead time, but at exit the registration is already in one’s own hands. Distributor-held registrations merge the regulatory role with the commercial interest, and once a channel dispute arises, the entire negotiating leverage sits on the other side of the table. An independent third-party holder separates the regulatory role from the channel, so changing distributors does not touch the registration itself. Because the statutory threshold is the same for all three, the comparison should be run entirely on commercial variables rather than on compliance arguments.

The second point: the cost of exit should be folded into the initial pricing. The registration is valid for 10 years, and changing channels within that period may cost transfer negotiations under RDC 903/2024 or even a fresh submission, which for Class I and II products is the only route. Putting those two costs side by side with the fixed cost of establishing a subsidiary, in one table, usually produces a clearer conclusion than intuition does, and it produces it before the decision is made rather than after.

Third, whichever structure is chosen, the AFE and the import arrangement must be designed separately. Holding the registration does not mean being able to import; the actual importer must hold an operating authorization that includes the import activity. GRZAN has seen arrangements in which a subsidiary held the registration while a distributor performed the imports, and once the authorization chain broke, neither side could move the goods. The distinction matters in daily operations as well: the holder appears on the registration certificate and on the label, the importer appears in the customs chain, and a change in either role must be checked against the other before it is executed.

The fourth point concerns vigilance responsibility: a structure can decouple commerce, but it cannot decouple statutory duties. The holder remains the first responsible party for vigilance response, and choosing an independent third-party holder does not shift that responsibility back to the manufacturer, however the service contract describes the division of work.

The fifth point concerns how the costs are measured. The costs of a subsidiary-held structure are explicit and visible from day one; the costs of distributor and third-party holding are implicit, surfacing mainly in exit negotiations and re-filing. Once the implicit costs are weighted by their probability of occurring and expressed as expected values, the ranking of the three structures frequently changes, which is precisely why a probability-weighted comparison is worth the effort before signing anything. As a practical estimate, price the exit scenario first and the set-up scenario second, because the exit numbers carry the uncertainty.

4. Practical recommendations

GRZAN recommends choosing according to channel stability. Where a long-term exclusive partner already exists and no change is contemplated, a distributor-held structure can be acceptable; where the plan is multi-brand and multi-channel distribution, a subsidiary or an independent third party should be preferred from the outset.

At signing, lock in three things: ownership of the registration, the duty to cooperate in transfers, and the named person with Portuguese capability responsible for vigilance response. These three determine the true running cost of the structure and deserve more negotiation time than the one-time service fee, which is easy to compare and comparatively unimportant over a 10-year registration life.

For third-party holder arrangements, also prepare a backup plan: agree that on termination of the service the holder cooperates unconditionally in the transfer, and pre-assemble a set of ready-to-file document templates that mirror what RDC 903/2024 requires for a double filing, so a real transfer can start without new drafting. The value of the backup is not only the fallback itself; it is one more option on the negotiating table, and it signals to the counterparty that replacing them is neither traumatic nor expensive.

One further GRZAN reminder: the structure choice should be read together with the product portfolio. If the same company carries both Class III/IV and Class I/II products, the former can transfer and the latter must be re-filed, so the actual workload of an exit depends on the ratio between the two, and that ratio should be calculated at project initiation rather than discovered during the exit.

5. Verification checklist

• □ Is the holder a legal entity established in Brazil and clearly named in the agreement
• □ Can the registration follow a change of channel (Class I/II cannot)
• □ Do the operating authorization and the import arrangement match the holder structure
• □ Is the vigilance response duty assigned to a named, Portuguese-capable person

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN supports manufacturers entering the Brazilian market across the full holder and import chain: holder-structure design, AFE and operating authorization planning, importer qualification, vigilance readiness and official fee budgeting. For tailored support on Brazilian license holders, import qualifications and fee budgets, contact info@grzanglobal.com.