The DDR in Brazil: how a registration holder authorizes a third party to import a medical device

The question usually comes a few weeks after the ANVISA registration is published. The manufacturer has a distributor or a hospital ready to buy, the first shipment is booked, and someone asks the holder for “the authorization letter.” In Brazil that request has a precise regulatory meaning. If the company clearing the device through customs is not the registration holder, ANVISA expects a specific document on the import file: the Declaração do Detentor da Regularização do Produto Autorizando a Importação por Terceiro, which everyone calls the DDR. If it’s missing, the import is rejected outright.

I am Julio Martinez-Clark, CEO of bioaccess®. We act as the in-country registration holder for medical device manufacturers in Latin America, and this question keeps coming up. This page covers what the DDR is, what the rules require, how it differs from a commercial authorization letter, what changes when the device is still investigational, and the checklist I use so the first commercial shipment doesn’t sit at the port.

One-sentence answer

When anyone other than the ANVISA registration holder imports a registered device into Brazil, each import file must include a DDR on ANVISA’s own template, linked to one importer and to the products on that import license, valid for no more than 90 days and signed by the holder’s legal representative and its technical responsible. The holder stays legally responsible for the product in Brazil.

What the rules actually require

The import regulation: ANVISA RDC 81/2008

Brazil’s technical regulation on imported goods under health surveillance is RDC 81 of 5 November 2008. ANVISA’s legislation database lists it as in force with amendments. The import-file rules quoted here were rewritten by RDC 208/2018, and the regulation was amended again in 2025. Chapter VII covers outsourced (“terceirizada”) imports:

• Who counts as a third-party importer. Item 1 covers imports between companies that hold ANVISA operating authorization (AFE) to import, or to import and manufacture; imports by predetermined intermediation (the “encomenda” and “conta e ordem” models); and imports by public health bodies and multilateral international organizations.
• The holder keeps the obligations. Item 5 puts the following on the holder of the product’s ANVISA regularization: compliance with the import rules at every step from shipment abroad to health clearance in Brazil, good practices in transport, handling and storage, and responsibility for the information on the import, even when a third party supplied it. Item 5.2 adds that the third-party importer still has to follow the regulation itself.
• The fee follows the holder. Item 6 says the health surveillance inspection fee (TFVS) is set by the size of the legal entity that holds the regularization, not by the importer’s size.
• The DDR, on every import. Item 7 says a third-party import goes ahead with the health authority’s consent, and that each import must include the clearance petition and a declaration from the holder authorizing the import. Under item 7(b), that declaration must (i) be tied to one single, exclusive legal entity, with any onward transfer of the authorization prohibited; (ii) be legally valid for no more than 90 days from signature; (iii) be signed by the holder’s legal representative and its technical responsible; and (iv) state the commitment to follow health legislation and acknowledge the penalties under Law 6.437/1977. For predetermined intermediation, item 7(c) also requires the authorization form in Chapter VIII.

For medical devices specifically, Procedure 4 in Chapter XXXIX makes device imports subject to an import license (LI) in SISCOMEX and health inspection before customs clearance (item 33). Item 36 lists the documents for the import file: the clearance petition, the commercial invoice, the bill of lading, proof of sterility for sterile products, and the declaration from the holder authorizing import by a third party.

Who the “holder” is: RDC 751/2022

ANVISA’s device registration rule, RDC 751/2022, defines the holder (Art. 4, VIII) as the public or private legal entity, manufacturer or importer, that is responsible for the device in Brazil and holds the marketing concession issued by ANVISA. The DDR is how that entity lets another company bring the product in without handing over that responsibility.

What ANVISA says about the template

• Two official models. ANVISA publishes the DDR for third-party importers on its forms page and a separate DDR for imports by health facilities. According to ANVISA’s notice on the current models, the first applies to companies that only do outsourced importing. The second applies to hospitals and health facilities that import directly for their own therapeutic or diagnostic use, and those products may not be passed on to another facility or sold.
• Tied to the import license. The same notice says the models now cite the import license that covers the products. A DDR that lists products outside the license under review is not allowed.
• Responsibility doesn’t move. ANVISA describes the DDR as the document that shows the holder knows all obligations for the product in Brazil are its own, and that they can’t be transferred to another company.

ANVISA’s manual for reviewing device import files (PAFPS, version 2, July 2018), section 8.1.4, adds the practical rules reviewers apply:

• The DDR is mandatory whenever the importer is not the holder.
• Only the model on ANVISA’s website may be used. No changes to its form or wording are allowed.
• File one DDR per import license, listing only the products on that license. A DDR with products not on the license goes into an “exigência” (a request for correction).
• The legal and technical responsible may sign by hand or digitally. A digitally signed document that was printed, scanned and attached is not accepted, because the signature can’t be verified. An e-CNPJ certificate validates only the legal representative’s signature, so the technical responsible has to sign another accepted way.
• A missing DDR leads to summary rejection of the import.

Sections 8.1.5 and 8.1.6 of the manual cover two related documents. The Chapter VIII responsibility form applies only to “encomenda” and “conta e ordem” imports. It is signed by the holder’s legal representative and technical responsible and by the importer’s legal representative. A complementary fee is due when the importer is a smaller company than the holder, which follows from item 6 above.

DDR versus a “commercial authorization letter”

This is where most first shipments go wrong. A commercial authorization letter (distributor appointment, territory, exclusivity) is a private document between the manufacturer, the holder and the distributor. It may be very useful for tenders or customers, but it isn’t the DDR, and ANVISA won’t accept it in place of one. The DDR has no commercial terms. It is a fixed regulatory template that ties one importer to the products on one import license for a period of up to 90 days. When someone asks for “the letter,” my first question is which of the two they need. For a first import, it is almost always the DDR, sometimes both.

Why it matters if you use an independent holder

Many manufacturers keep their registration with a neutral holder so they can add or change distributors without re-registering. I explained why on our page about keeping the license separate from the channel. The DDR is what makes that model work day to day. Every distributor that imports needs its own DDR, and the authorization can’t be passed on. Each DDR lasts at most 90 days and covers only the products on one import license, so a distributor importing every month needs a steady flow of DDRs from the holder. The holder still carries the obligations under item 5. So a good holder reviews each request: whether the importer has the right authorization, whether the products and presentations match the registration, and whether there is an open field action or complaint that should hold the shipment. That review protects the manufacturer. It is not red tape.

If the plan is to move the registration itself to a new company, that is a different process, covered in how to transfer a device registration to a new holder. The DDR leaves the registration where it is and authorizes imports under it.

What changes in a first-in-human or early feasibility study

An investigational device has no registration yet, so there is no holder and no DDR. In Brazil, devices for clinical investigation are imported under the Clinical Investigation Dossier (DICD) set out in RDC 837/2023:

• Art. 70: the import is subject to health inspection through a clearance petition in SISCOMEX, and the importer must put the number of the Official Gazette (DOU) resolution approving the DICD in the product description.
• Art. 71: the file needs the bill of lading and the commercial invoice. If someone other than the DICD holder imports, a document delegating import responsibilities, signed by both parties, is required. That is the trial-side counterpart of the DDR.
• Arts. 72 to 75: the outer packaging must show the DICD resolution number, storage conditions and a lot or serial number. Products or quantities not covered by the DICD may not enter. The products may not be sold, and the purpose of the import may not change.

I plan both paths together. The importer of record you choose for the study (see importer of record for clinical trial devices) and the unit-level trail you keep (see investigational device accountability) are often what sets up the commercial structure later, once the device is registered.

How I set it up

1. Name the import model first. Is it a third-party importer buying for its own resale, an “encomenda” or “conta e ordem” import (which adds the Chapter VIII form), or a hospital importing for its own use (the health-facility DDR)? Each uses a different document set.
2. Check the importer before signing. Chapter VII, item 1.1 covers imports between companies with ANVISA operating authorization to import. Get the importer’s CNPJ and AFE details at the start, because the Chapter VIII form asks for them as well.
3. Build the DDR from the import license. The product list on the DDR should match the license line for line. Nothing extra and nothing missing.
4. Use the current ANVISA template as published. Download it fresh. Don’t reformat it, translate it or add a letterhead that changes the text.
5. Sort out signatures early. You need both the legal representative and the technical responsible, in a format ANVISA can verify. Don’t print and scan a digitally signed file, and don’t rely on e-CNPJ alone for the technical responsible.
6. Track the 90-day clock. I keep a register of every DDR issued: importer, import license, products, signature date and expiry. That way nothing expires in transit, and the holder can show who it authorized.
7. Check the fee. If the importer is smaller than the holder, have the complementary fee paid and attached before the file is finally filed.

Common mistakes

• Sending a commercial authorization letter where ANVISA expects a DDR.
• Issuing one open-ended DDR for “all products, all shipments,” or one that names two importers.
• Letting the distributor’s customs broker reuse a DDR issued to another company.
• Signatures that ANVISA can’t verify, or a missing technical responsible.
• Listing presentations or models that are on the registration but not on the import license under review.
• Assuming the DDR moves product responsibility to the importer. ANVISA says it can’t. The holder stays responsible.

How bioaccess® runs this

When bioaccess® is the Brazil registration holder, we handle DDR requests ourselves. We confirm the import model, check the importer’s authorization, prepare the ANVISA template from the import license, collect the legal and technical signatures and keep the register. The manufacturer’s distributors deal with us, so the holder’s controls and contact details stay in one place. The same approach applies across the countries on our market access page, and the Brazil specifics are on our ANVISA registration holder page.

FAQ

Is the DDR needed if the holder imports the device itself?

No. ANVISA’s import manual says the DDR is required whenever the importer is not the holder. If the holder is also the importer on the license, no DDR is needed.

How long is a DDR valid?

No more than 90 days from signature, under RDC 81/2008, Chapter VII, item 7(b)(ii). In practice it is also tied to the specific import license it cites.

Can one DDR cover two distributors?

No. Item 7(b)(i) ties it to one single, exclusive legal entity and prohibits passing the authorization on.

We are only running a clinical study. Do we need a DDR?

No. Investigational devices are imported under the DICD rules in RDC 837/2023. If the importer is not the DICD holder, you need the signed delegation of import responsibilities instead.

Sources: ANVISA RDC 81/2008 (as amended, including by RDC 208/2018), Chapter VII, items 1, 5, 6 and 7, Chapter VIII, and Chapter XXXIX, Procedure 4, items 33 and 36; ANVISA RDC 751/2022, Art. 4, VIII; ANVISA RDC 837/2023, Arts. 70 to 75; ANVISA, “Novos modelos de DDR já estão disponíveis” (published 4 July 2022); ANVISA DDR forms pages (third-party importer and health facility); ANVISA, Manual de Análise de Processo de Importação de Produtos para Saúde, PAFPS, version 2 (July 2018), sections 8.1.4 to 8.1.7.