ANVISA Moves Class I/II Foreign Manufacturer Records to Solicita

Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has moved the cadastro of international legal manufacturers and manufacturing sites for risk classes I and II, including in vitro diagnostic (IVD) devices, onto the Solicita electronic petitioning system. The 14 August 2026 notice states that companies may already file these requests and that they must use subject code 80326.

The cadastro is the step that generates the Código Único de Fabricante Internacional (unique international-manufacturer code). ANVISA says that code provides origin traceability and must be indicated in regularization filings for imported products. The operational change is therefore not a new product class or a new registration pathway. It is the electronic process for the manufacturer-identity record that those imported-product filings must indicate.

Class III and IV manufacturer cadastro is unchanged. ANVISA says that procedure continues to run together with petitioning for Certificação de Boas Práticas de Fabricação (CBPF).

What ANVISA put exclusively into Solicita 80326

ANVISA’s notice says that requests to create, alter, and inactivate the cadastro of international manufacturers in classes I and II, including IVDs, are now made exclusively through Solicita under subject 80326. The stated purpose is to modernize handling and to protect the integrity and reliability of cadastral data.

The accompanying instruction PDF, published the same day, tells the interested Brazilian company (the interessada) to check first whether a Código Único already exists:

• in Solicita, by unique code, country, or company name, searching a fragment of the legal name to improve the match; and
• on ANVISA’s consultation portal at Consultas Empresas Internacionais.

ANVISA will not grant requests that arrive with incomplete documentation or unsigned forms.

Documents required to create a cadastro

To request a new cadastro, the interested company must open subject 80326 in Solicita and attach:

1. The Formulário de Solicitação de Cadastro/Inativação de Fabricante Internacional e Unidade Fabril Internacional (Dispositivos Médicos e IVD - Classe de Risco I e II), available from the subject consultation in Solicita.
2. A manufacturer declaration in Portuguese, English, or Spanish authorizing the Brazilian company to represent it. The declaration must identify the foreign company (legal name and complete manufacturing-site addresses) and include authorization text in this form: the manufacturer authorizes the named Brazilian company and CNPJ to request cadastro in ANVISA’s database and to be its representative in Brazil for notification of products manufactured by that company. A letter of authorization may be used if it contains similar information.
3. A competent-authority document evidencing the manufacturer’s or manufacturing site’s legal name and address. ANVISA’s examples are a Certificate of Free Sale, a Certificate of Registration (CR), ISO 13485, or an MDSAP certificate.

Those examples are illustrations in the instruction PDF, not an exhaustive list of acceptable evidence.

Inactivation is the same Solicita flow, with a hard limit

Inactivation of an existing Código Único for medical devices and IVDs also runs electronically through Solicita on the same cadastro flow. The form must be completed and signed, including a detailed Field 3 justification. ANVISA says additional supporting documents and manufacturer authorization letters are not required for inactivation.

The limit is operational: ANVISA will inactivate a manufacturer’s or manufacturing site’s unique code only if no active notification or registration is linked to that cadastro in ANVISA’s system.

Keep the two alteration statements separate

The news page and the instruction PDF do not use identical language for updates.

• The news page says creation, alteration, and inactivation of Class I/II international-manufacturer cadastro now run exclusively through Solicita subject 80326.
• The PDF’s final paragraph says that altering or updating unique-cadastro data requires an alteration petition for each active product process linked to that manufacturer in ANVISA’s system.

Pure Global is not collapsing those two statements into a single invented procedure. Until ANVISA publishes a clearer reconciliation, teams that need to change unique-code data should treat both instructions as in force: use the Solicita 80326 cadastro flow described in the notice, and do not assume that a manufacturer-level 80326 filing replaces product-level alteration petitions where the PDF requires them.

How to follow a filed request

ANVISA says petition status can be checked in Situação de Documentos Técnicos. If the request is granted, the new unique code can be consulted on the international-companies portal or on the product-petitioning screen.

If 10 working days have passed from the protocol date, the code is still unavailable, and the company has not received an ofício explaining a rejection, ANVISA directs the user to official support channels, including the electronic service form. That 10-working-day mark is a follow-up trigger, not a statutory approval deadline and not a promise that a complete file will be granted in 10 days.

ANVISA did not publish a new fee, a new Class I/II product dossier list, or a transition window for this cadastro change. The notice presents the Solicita flow as already operating.

What manufacturers and Brazil holders should do now

Pure Global’s recommended work sequence, derived from the notice and instruction PDF:

1. Inventory every foreign legal manufacturer and manufacturing site used in current or planned Class I/II, including IVD, import regularizations. Record whether a Código Único already exists.
2. Search before filing. Use Solicita and Consultas Empresas Internacionais so a second cadastro is not opened for a company that already has a unique code.
3. Prepare the 80326 pack for any missing Class I/II site: signed form, manufacturer declaration or equivalent authorization letter, and name/address evidence from a competent authority.
4. Do not inactivate a live site. Confirm that no active notification or registration is linked before using the inactivation flow.
5. Treat unique-code data updates as product-linked until ANVISA says otherwise. Map each manufacturer to every active product process that would need an alteration petition under the PDF’s last paragraph.
6. Leave Class III/IV on the CBPF-linked procedure. This notice does not move those manufacturer records onto subject 80326.

For Brazil classification, registration, and local representation context, see Pure Global’s ANVISA glossary entry, Brazil market overview, and ANVISA medical device regulations.