Brazil Anvisa Medical Device Registration Service For IVD Device

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

An IVD filing in Brazil is a regulated product-specific submission, not a single certificate sold by an intermediary. The safe starting point is the intended use, test/analyte, specimen, user, product variants and Brazilian filing holder. ANVISA Resolution RDC 830/2023 governs IVD notification and registration, including IVD instruments.

This page covers execution: the petition type, complete submission set, who signs and holds it, authority questions, publication and subsequent changes. A service provider may coordinate these steps, but only ANVISA determines the regulatory outcome.

Choose the IVD filing route before building the packet

RDC 830/2023 applies classification rules to the manufacturer’s intended purpose; where multiple rules apply, use the highest resulting class. The term “registration” is often used commercially for both paths, but the legal procedures differ. Do not classify by assay name alone.

Verified starting case	Correct petition path	Release gate
Class I IVD	Notification (notificação); keep the full required technical file available, although a Class I technical dossier is not submitted with the initial notification.	Obtain publication of the notification number before routine supply.
Class II IVD	Notification; include the Class II technical dossier required by Article 13, together with labels, instructions and relevant annexes.	Publication of the notification number; notification is not a substantive premarket technical approval.
Class III or IV IVD	Registration (registro); submit the full class-appropriate dossier and GMP certificate or proof of CBPF application.	ANVISA decision/publication; a valid published CBPF is required for approval.

First exclude genuinely out-of-scope items (for example, research-use-only products or products solely for instrument servicing). A claimed exemption does not authorize clinical commercial claims. For an existing legacy product, re-check status: ANVISA cancelled affected notifications in 2025 where required reclassification petitions had not been lodged.

Route-specific exceptions to check before filing

Lay-user self-tests: RDC 830/2023 Article 10 restricts supply to lay users for specified test purposes, including particular infectious-agent, blood-typing, genetic, cardiac/tumour-marker and drug assays. Check the precise wording, its genital-infection exception and any specific RDC before making a self-test claim; the assay name or risk class alone is insufficient.
Non-embedded IVD-related SaMD: RDC 657/2022 regulates SaMD. ANVISA guidance identifies IVD petition subjects 80298/80299 for certain dedicated, non-embedded SaMD accessories to individual IVD products. That guidance says such software cannot be bundled as an accessory within an IVD family filing; check the separate SaMD route (subjects 80272–80274, as applicable) and live checklists before filing.
Used or refurbished IVD instruments: RDC 830/2023 Article 2(2) directs these to RDC 579/2021. New-device notification or registration by itself does not establish permission to import, sell or donate a used unit.

Allocate the applicant, manufacturer and review responsibilities

Foreign manufacturers cannot obtain ANVISA product authorization directly. A legally established Brazilian company must be the applicant/holder (detentor). Allocate the record owner before signing letters or paying filing fees.

Before appointing the Brazilian holder, verify that its ANVISA company operating authorization (AFE), where required, covers the regulated activities it will perform, particularly importation. Confirm its registration details and authorized signatories; appointing a consultant alone does not make that consultant the product authorization holder.

Party	Must supply or control	Critical responsibility
Legal manufacturer	Exact intended use, models, manufacturing sites, design/performance and stability records, labels and risk file.	Issue authorization for the Brazilian applicant and keep claims consistent across the dossier.
Brazilian applicant / holder	Company regulatory authorization, filing-system access, signed forms, official fee payment and product records.	Submit the petition; respond to ANVISA; maintain current regularization after publication.
Legal / technical responsible persons	Review of statements, product evidence and signed submission.	Article 56 assigns responsibility for information and documents to these designated persons.
Filing coordinator	Gap log, indexed packet, draft forms, query register, decision trail and handover.	Coordinate only; cannot replace the holder or promise approval.

Compile the correct IVD dossier and supporting evidence

Use the live checklist for the chosen petition subject, RDC 830/2023 Articles 13–14 and the class-specific Annex II dossier matrix. Prepare one version-controlled device identity across every document.

Packet component	What must be checked before filing
Identity and route	Intended purpose, analyte, specimen, professional/self-test use, clinical context, all models and combinations, risk rule, technical name and family-eligibility reasoning.
Administrative proof	Correct petition form, Brazilian company identifiers and authorized signatories; for imports, manufacturer authorization letter legalized/apostilled under Article 13 or 14 and its currency, names and addresses.
Product evidence	Risk management, technical descriptions, manufacturing-site map, performance evidence (analytical and clinical where applicable), controls/calibrators and traceability, stability/transport evidence, safety and performance compliance.
Product images for notification	For Class I/II notification, Article 13 also calls for images of the product, its parts and accessories. Do not confuse these images with the separate primary/secondary label images; check the subject-code checklist.
Brazilian-facing information	Portuguese labels and instructions for use, packaging images, intended-user warnings and ANVISA/holder identification; check special restrictions for self-tests and electronic instructions.
Conditional proof	For Class III/IV: ANVISA CBPF or petition protocol at filing; valid published CBPF before approval. Check any mandatory conformity certificate for IVD instruments and any INCQS prior analysis.

Under Article 63, petition forms, labels, IFUs and user/operator manuals submitted to ANVISA must be in Portuguese. Other petition documents may be presented in Portuguese, English or Spanish, subject to the applicable rules; the imported-manufacturer authorization letter has the specific Article 13/14 language and authentication conditions.

Digital-only instructions are not universally acceptable: Article 55 prohibits exclusively non-printed IFUs for self-tests, PoCT, instruments intended for home use and instruments operated by laypeople. Verify the format for the exact model and user.

IVD family grouping now follows IN 320/2024, which expressly repealed IN 3/2015 even though some older RDC 830/2023 cross-references still cite it. Under IN 320/2024 Article 12, an already published single-product filing cannot subsequently be converted into a family; decide eligible grouping before the first filing.

An apostilled manufacturer letter is not interchangeable with a generic distributor contract. RDC 830/2023 prescribes its authorization content, accepted languages and the two-year recency rule when the document has no explicit validity. Verify grouping under the current applicable rules instead of assuming all reagents, controls and instruments belong in one family.

Separate mandatory requirements from supporting material: RDC 848/2024 sets essential safety and performance principles for IVDs; technical standards can provide supporting evidence but do not by themselves replace applicable law. ANVISA manuals are non-binding filing guidance, while a mandatory conformity certificate is required only where a specific rule applies.

Sequence the submission and record each checkpoint

Use a gated sequence: do not advance a deficient file merely to secure a protocol number.

Freeze scope. Sign off one product/model matrix, intended-purpose wording, risk class, grouping and Brazilian holder.
Validate prerequisites. Check applicant credentials, legal/technical signatories, factory identifier where applicable, manufacturer letter, CBPF status and conditional laboratory/certification requirements.
Lock dossier. Cross-check labels, instructions, performance summaries, manufacturer/site names and evidence versions against the selected regulatory subject code.
File and pay. Select the live ANVISA petition subject in the applicable electronic system; generate/pay the official TFVS fee as required; transmit the prescribed documentation and retain protocol evidence.
Handle authority traffic. Log ANVISA communications and technical requests, assign evidence owners, respond with controlled revisions and keep a dated audit trail.
Confirm publication. Verify actual notification or registration number and product details in the official publication/consultation; do not treat submission or fee payment as permission to market.

Operational 2026 checkpoint: for imported Class I/II devices, including IVDs, ANVISA now uses Solicita subject 80326 for the international manufacturer identifier process; Class III/IV factory identification remains linked to CBPF petitioning. Confirm the live system and code immediately before filing.

Prevent avoidable rejection and technical delays

RDC 830/2023 Article 11 permits summary refusal for specified incomplete or obsolete materials, rather than offering a guaranteed opportunity to repair. Pre-file triage is therefore substantive work.

Frequent stop	Pre-submission response
Misclassified assay or assumed family	Document the intended-use classification rule; test each model and family eligibility, including the 2024–2025 reclassification legacy.
Names, authorization or labels conflict	Reconcile legal-manufacturer address, local holder, signatures, translated/authorized letter and Portuguese label/IFU across documents.
Performance/stability evidence does not match claims	Make an analyte/specimen/claim-to-report index; identify missing real-time stability and clinically relevant validation.
CBPF or specialist laboratory gate missed	Track CBPF application versus published certificate separately; check whether the specific IVD triggers INCQS prior analysis or instrument conformity evidence.
Authority request missed or treated as approval	Keep portal and correspondence monitoring, dated response ownership, submission receipts and a separate publication check.

Keep the published IVD authorization valid

Publication starts ongoing work, not the end of the service. A registro lasts 10 years from its Official Gazette publication and can be renewed; a notificação does not require renewal. Neither status excuses safety/performance, GMP and post-market obligations.

Change control. Categorize a planned change as prior-approval, immediate-implementation filing or non-reportable under RDC 830/2023 and the applicable petition rules; a major change is not effective until the required ANVISA decision.
Current file. Maintain current technical evidence, Portuguese IFU/labels, factory details and traceable versions; Class I files remain available for inspection even when not submitted initially.
Monitoring. Keep an ANVISA query and re-evaluation contact process and the company’s complaint/field-action escalation.
Expiry and transitions. Calendar the registro renewal and CBPF; for historical notifications verify any reclassification cancellation before treating an old number as valid.

What our filing-coordination work produces

An execution mandate should identify the product, petition route and holder, then define tangible deliverables rather than a promised approval date:

Signed route and model/family decision sheet.
Document request list with named owner, missing-evidence log and normalized dossier index.
Brazilian labels/IFU consistency review and import authorization-letter check.
Filed petition reference, official-fee receipt, ANVISA correspondence tracker and responses.
Publication verification plus change-control/renewal handover.

Related work that is outside this IVD filing

For broad classification strategy rather than executing one IVD petition, see

This page stays focused on an IVD-specific submission; generic medical-device regime maps and country-wide market-access summaries are separate tasks.

Primary regulatory sources

Primary law and authority guidance (check the latest version before submitting):

IVD filing questions

Can a US or EU IVD manufacturer file directly with ANVISA?

No. A Brazilian legal entity serves as the applicant/authorization holder; the foreign manufacturer supplies a compliant authorization letter and underlying product evidence.

Is notification a faster version of full ANVISA technical approval?

No. Class I/II notificação is a different regime without routine premarket technical assessment. The required publication and continuing technical-file duties still matter.

Can we submit a Class III test while Brazilian GMP certification is pending?

RDC 830/2023 permits the CBPF application protocol at petition and analysis stage, but registration approval depends on publication of a valid ANVISA CBPF and satisfaction of other requirements.

May a self-test or combined assay use the same route as a professional single-analyte kit?

Not automatically. The declared user and intended purpose, highest applicable risk rule, self-test restrictions and permitted family grouping must each be assessed.

What if our existing IVD notification dates from before RDC 830/2023?

Review the new class and current database status. ANVISA reported cancellations in 2025 for affected products whose required notification-to-registration reclassification petitions were not submitted on time.