Brazil Anvisa Medical Device Registration Service

Scope and evidence must be confirmed before any paid tests or filings.

ANVISA medical device filing is an execution project, not a certificate ordered from a consultant. The Brazilian applicant must qualify to petition, the manufacturer must supply defensible product evidence, and the chosen petition must match the device and its intended use. Filing assistance can coordinate those dependencies; ANVISA alone decides the administrative outcome.

1. Choose the petition before assembling the package

Gate	ANVISA route	What the filing team must verify
Non-IVD medical device, risk class I or II	Notificação (notification), under RDC 751/2022	Intended purpose and classification rule; correct notification form and subject code; technical dossier retained and available to ANVISA. Notification has no prior technical assessment, but is not an exemption from compliance.
Non-IVD medical device, risk class III or IV	Registro (registration), under RDC 751/2022	Full technical dossier and prescribed attachments; applicable ANVISA Good Manufacturing Practices certification (CBPF) and product-specific conformity evidence. Approval is a substantive authority decision.
In-vitro diagnostic device (IVD)	Separate framework, RDC 830/2023	Confirm IVD-specific classification, forms, tests and route before opening any case. Detailed IVD filing is addressed separately.

Scope stop-check. Before choosing a code, distinguish routine commercial products from exceptions. IVD devices (including IVD instruments) follow RDC 830/2023; personalized/custom-made devices are governed by their specific framework, RDC 925/2024 (which replaced RDC 305/2019); used or reconditioned devices are addressed separately under RDC 579/2021. A device intended exclusively for an authorized clinical investigation can be exempt from this commercial notification/registration route, but that does not authorize general sale or other uses. Establish product status and intended destination before using the class I–IV table.

This page concentrates on performing a non-IVD ANVISA filing, rather than presenting a country-wide market-access classification guide. Risk class is not determined by the overseas certificate or the marketing name alone. A standalone software device may also need the specific SaMD rules of RDC 657/2022. For a complex classification or evidence strategy, consult the ANVISA registration advisory page; for diagnostic tests, use the IVD filing service page.

2. Who files: the Brazilian holder is not the foreign factory

ANVISA does not grant a foreign manufacturer a Brazilian product authorization directly. A legally established Brazilian applicant/holder (detentor) must be designated and properly registered for its regulated activities. Check its CNPJ, ANVISA company registration, relevant AFE authorization, local sanitary licence where applicable, and authorized system users before starting the petition.

Party	Operational responsibility	Evidence to hand over
Foreign legal manufacturer	Confirms intended use, models and sites; supplies risk, performance, clinical, quality and labeling evidence; signs authorization documents.	Approved technical-file version, manufacturer/site identifiers, applicable foreign marketing document and signed authorization.
Brazilian applicant / future holder	Has legal responsibility in Brazil; selects and submits the correct petition, pays regulatory fee and receives ANVISA correspondence.	CNPJ and company permissions, access to Solicita, correct petition code, signed forms and submission records.
Filing coordinator	Maps the dossier against the exact ANVISA checklist, controls translations/versions, tracks missing documents and drafts responses for holder/manufacturer review.	Document register, gap log, release checklist and dated correspondence tracker; it cannot issue ANVISA approvals.

August 2026 operational check: for imported class I–II devices, ANVISA moved foreign-manufacturer code requests to Solicita, subject code 80326. This manufacturer registration/unique code is a separate dependency from the device notification. ANVISA says class III–IV manufacturer-code handling remains linked to the GMP-certification petition. Verify the manufacturer's status early, rather than discovering the gap at submission.

Manufacturer-code release check. The 80326 petition is a request to create or change the foreign manufacturer record, not itself the issued Unique Foreign Manufacturer Code. Confirm the accepted code in ANVISA consultations or the product filing screen; if none appears after ten working days and no rejection notice was received, ANVISA directs the applicant to its official support channel. Do not replace the issued identifier with a filing receipt.

3. Pre-submission dossier: six concrete checks

Regulatory identity: intended purpose, classification rule, manufacturer, production sites, product names, model list and permissible grouping (single product versus family). ANVISA does not allow converting an approved single-product registration into a family registration, or vice versa.
Applicant eligibility: Brazilian holder's CNPJ, applicable AFE and sanitary licensing status, authorized signatories and system access; a distributor's commercial contract alone does not replace these checks.
Technical dossier: device description, variants, design and manufacture, risk management, verification and validation, applicable safety/performance evidence under RDC 848/2024, clinical support where necessary, and consistent labeling/instructions for use. For notification, required technical evidence must still be available to ANVISA even where not routinely submitted for advance technical review.
Imported class III–IV registration papers: check RDC 751/2022 art. 14 for the manufacturer's authorization to represent/commercialize and proof of registration/free sale or equivalent. Check the document's age, language, apostille/consular formalities and any applicable exceptions against the actual petition; do not assume an informal distributor letter suffices.
Conditional gates: for classes III–IV, verify the ANVISA GMP certificate or qualifying certification application protocol, noting that a protocol is not the same as a final certificate. Determine whether mandatory INMETRO conformity certification, an economic-information report or another product-specific attachment applies.
Submission metadata: current ANVISA código de assunto, its mandatory checklist, filing form, tax (TFVS), planned attachments, filenames and consistent Brazilian Portuguese product-facing information. Do not reuse a code merely because a previous product used it.

Separate GMP workstreams. Even though ANVISA unified CBPF subject codes in February 2026, RDC 497/2021 article 19 still requires separate CBPF petitions for the medical materials/equipment line and the IVD line. A manufacturer supplying both categories must not combine them in a single certification petition. This distinction concerns GMP certification, not the non-IVD device filing on this page.

Imported class I–II notifications have a separate mandatory manufacturer-authorization gate under RDC 751/2022, art. 13: obtain a properly authenticated statement from the legal manufacturer expressly authorizing the Brazilian applicant to represent and market the device. It must identify both parties (legal names and full addresses) and state the manufacturer’s awareness of, and compliance with, the applicable Brazilian GMP requirements. Under arts. 13–14, an authorization statement without an express validity period must have been signed within the preceding two years. For class III–IV registration, the foreign marketing/free-sale evidence has a corresponding two-year issuance rule when it states no validity period. Do not confuse these two document routes: art. 13 does not impose the art. 14 foreign free-sale document on every class I–II notification.

RDC 751/2022, art. 10 requires application forms, labeling models and instructions for use/manuals in Portuguese. Other dossier documents may be supplied in Portuguese, English or Spanish subject to specific rules; the manufacturer statement and, where applicable, the foreign authorization/free-sale document need a sworn translation if in another language. Check the accepted consular/certification or apostille route for each document instead of assuming a universal apostille or Portuguese translation requirement.

Release rule: no petition is filed until the holder confirms its authorizations and every mandatory item in the selected checklist has a named owner and a verified file. A missing mandatory document or incomplete form can lead to summary refusal rather than an opportunity to repair through a technical request.

4. Submission sequence and authority interactions

Lock scope: approve the intended-use statement, product grouping, class, petition route and the Brazilian entity that will hold the record.
Clear upstream blockers: confirm company permissions; collect manufacturer authorizations and foreign-market documentation where required; start applicable GMP and conformity-evaluation workstreams before the product petition if their status affects acceptance.
Build a filing index: align each form field and technical annex with the current petition-code checklist; verify cross-document model numbers and legal names; have the legal and technical signatories approve the final version.
Petition through the active official channel: the Brazilian account holder uses ANVISA's Solicita workflow, selects the appropriate initial petition and handles the applicable TFVS payment. Follow the current code's instructions for document delivery; older webpages may describe legacy postal stages.
Track the case: retain the protocol/reference, payment proof, final attachments and version history. Monitor Situação de Documentos, ANVISA's electronic communications and any formal technical request; route questions to the responsible evidence owner and respond within the deadline stated by ANVISA.
Verify the decision: check the official decision and publication in Diário Oficial da União (DOU) and ANVISA's product register. An application receipt, imported-product certificate or GMP filing is not the product's marketing authorization.

The public government registration service provides category-dependent legal analysis periods; these are not promised delivery dates. Completeness, technical questions, certification status and ANVISA's decision can affect the actual timetable. IN 290/2024 offers an eligible, documented reliance-based optimized assessment route for certain high-risk devices already authorized by recognized foreign regulators; it is not automatic recognition of an FDA or other foreign approval.

5. Delay and refusal register: fix the cause, not just the format

Warning sign	Likely consequence	Preventive filing control
Intended use differs across IFU, clinical evidence and form	Classification or evidence questions	Approved intended-use master and line-by-line claim reconciliation before signing.
Holder/foreign manufacturer names or unique manufacturer code do not reconcile	Wrong applicant record or administrative hold	Legal-entity and plant mapping; complete 2026 foreign-manufacturer registration where applicable.
Imported registration letter or free-sale evidence lacks required authentication, validity or translation	Inadmissible or deficient attachment	Country-by-country document formalities review against RDC 751 art. 14 and the live checklist.
Incomplete mandatory checklist; GMP or INMETRO dependency treated as an optional afterthought	Summary refusal, technical request or approval hold	Checklist sign-off and separate certification tracker with no unsupported approval assumptions.

A technical request is not permission to invent data, change a product's intended use silently or miss ANVISA's stated reply deadline. Escalate substantive gaps to the manufacturer and Brazilian holder, document each answer's source and submit only approved replacements.

6. Keep the authorization usable after publication

For classes III–IV, ANVISA states the registration is valid for ten years from publication. The renewal petition is generally filed between 12 and 6 months before expiry; renewal and a substantive product change are distinct petitions. Class I–II notifications do not require periodic revalidation, but compliance and changes remain controlled. Plan holder-managed change petitions for changes to approved information, and continue appropriate quality, vigilance and records obligations. Whether a particular change needs prior ANVISA action must be determined under the applicable change rules, not assumed from a manufacturer's internal change notice.

For post-market changes, RDC 751/2022, art. 16 distinguishes changes requiring ANVISA approval, changes eligible for immediate implementation and non-reportable changes. The holder must classify the exact change, use the applicable petition where required and retain non-reportable changes in its quality system; not every editorial or administrative update needs a fresh ANVISA petition.

7. Scope of a filing-coordination assignment

A practical service brief defines three outputs: (a) a route-and-holder readiness memo, (b) an indexed submission package with signed document checklist, and (c) a protocol/decision tracker with responsibility for responses and a post-decision action list. The client supplies real technical evidence; the Brazilian authorized applicant performs the regulated submission. No consultant can guarantee approval, a fixed ANVISA date or an exemption not supported by the rules.

To start, provide the device's intended-use/IFU draft, model list, manufacturer and factory details, proposed Brazilian holder, current AFE status, existing technical file, and foreign approvals. For broader Brazilian product regimes see Brazil market-access coordination; for a separately applicable equipment conformity workstream see INMETRO certification execution.

Frequently asked questions about ANVISA filings

Can a foreign manufacturer submit directly without a Brazilian company?

No. ANVISA identifies the Brazilian company as the accountable applicant/holder. The foreign manufacturer provides the evidence and authorizations; confirm the holder's legal and operational eligibility before filing.

Can I treat class II notification as an automatic product approval?

No. Notification normally avoids prior technical evaluation, but still requires a compliant petition, appropriate technical records and the official publication/regularization. The product cannot be marketed merely because a draft was created or a fee paid.

Is an FDA clearance or EU CE certificate enough for class III registration?

No. Foreign authorization is not a substitute for Brazilian regularization. IN 290/2024 may support optimized ANVISA assessment where its specific authority, product-identity and documentation conditions are met; the decision remains with ANVISA.

May a class III registration be filed before ANVISA issues GMP certification?

RDC 751/2022 allows qualifying proof of a GMP-certification application in the registration dossier. That does not mean ANVISA can grant the final product authorization without the applicable GMP certificate being issued. Review the manufacturing sites and the current petition status.

What if we want to add models or switch distributors after approval?

Check whether additional models fit the authorized family and which change petition applies. An approved single-product registration cannot simply become a family registration. Distributor changes and transfer of the Brazilian holder are different legal/operational questions; do not implement them as silent dossier edits.