ANVISA · structured requirements

🇧🇷 Brazil medical device regulatory data

Explore the medical device requirements currently available for Brazil, organized by topic and linked to official sources.

52 facts24 dimensions23 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Mandatory alert advertising

advertising.alert-advertising-anuencia

Fact-level verified

When products on the market prove harmful or non-compliant, the responsible company is obliged to broadcast alert advertising to the population, within the deadline and conditions set by the sanitary authority, subject to a fee for examination and prior approval (anuência prévia) of the content.

Conditions

Lei 9.782/1999 Art. 41-B.
Implemented for health-product field actions by RDC 551/2021 Art. 8 (mass-media alerts); RDC 743/2022 Anexo provides a 30-day analysis deadline for 'Anuência para Veicular Publicidade Contendo Alerta à População'.

Advertising concordance rule

advertising.concordance-registration

Fact-level verified

Every communication or advertisement of a device placed on the market must be in strict concordance with the information presented by the notification/registration holder to ANVISA (RDC 751/2022 Art. 32 for devices; RDC 830/2023 Art. 32 identically for IVDs).

Conditions

No prior advertising authorization is required for ordinary device advertising; the rule is concordance with the registration, backed by sanctions in Lei 6.360/1976 Arts. 58, 59 and 67 I.

Effective from 2023-03-01

RDC 830/2023 Art. 32 (IVDs): 'Toda comunicação ou publicidade de dispositivo médico para diagnóstico in vitro veiculada no mercado de consumo deve guardar estrita concordância com as informações apresentadas pelo detentor de notificação ou registro à Anvisa.'

No device-specific advertising RDC in force

advertising.regime-no-specific-rdc

Fact-level verified

ANVISA's official advertising-legislation page lists, under 'Produtos para saúde', only RDC 185/2001 - which was revoked by RDC 751/2022 - so no device-specific advertising RDC currently appears in that index; the operative rules are the concordance clauses (RDC 751/830 Art. 32) and Lei 6.360/1976.

Conditions

Top-level legislation on the page: Lei 6.437/1977, Decreto 79.094/1977, Lei 6.360/1976.

Sanctions: Lei 6.360/1976 Art. 67 I - 'rotular os produtos sob o regime desta Lei ou deles fazer publicidade sem a observância do disposto nesta Lei e em seu regulamento ou contrariando os termos e as condições do registro'.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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IVD registration validity

authorization.duration

Fact-level verified

IVD registrations are likewise valid for 10 years counted from publication in the Diário Oficial da União.

Conditions

RDC 830/2023 Art. 12; IVD notifications exempt from revalidation (Art. 28).

Effective from 2024-06-01

Automatic revalidation at lapse

authorization.lapse

Fact-level verified

If ANVISA has not decided the revalidation petition by the registration expiry date, the registration is automatically revalidated, regardless of a decision.

Conditions

RDC 250/2004 Art. 1º (same provision as the filing window).

Revalidation filing window

authorization.renewal

Fact-level verified

Registration revalidation must be requested between 12 months (maximum) and 6 months (minimum) before the registration expiry date.

Conditions

RDC 250/2004 Art. 1º, as amended; RDC 751/2022 Art. 27 §2º and RDC 830/2023 Art. 27 §2º refer revalidation to this rule.
Separate track: CBPF certificate renewal is filed between 270 and 180 days before expiry (RDC 497/2021 Art. 37).

Device registration validity

approval.registration-validity-years

Fact-level verified

Device registrations are valid for 10 years from the date of publication in the Diário Oficial da União (DOU) and may be successively revalidated for equal periods.

Conditions

RDC 751/2022 Art. 11; notifications (class I/II) are exempt from revalidation (Art. 28).

Effective from 2023-03-01

Registro FAQ Q8 confirms the count runs from DOU publication.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.anvisa-mandate

Fact-level verified

ANVISA (Agência Nacional de Vigilância Sanitária) is the federal competent authority for medical devices and IVDs: a special-regime autonomous body (autarquia sob regime especial) linked to the Ministry of Health.

Conditions

Applies to all device classes.
Established by Lei 9.782/1999 Art. 3º.

Art. 7º assigns ANVISA the powers to authorize company operation (inciso VII) and grant product registrations (inciso IX).

Statutory product scope

authority.anvisa-product-scope

Fact-level verified

Medical devices fall within ANVISA's statutory scope via Lei 9.782/1999 Art. 8º §1º VI, which covers medical-hospital, dental and hemotherapy equipment and materials and laboratory and imaging diagnostics.

Conditions

Devices now regulated in detail by RDC 751/2022; IVDs by RDC 830/2023.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Post-change packaging run-out

change.available-outcomes

Fact-level verified

Following an alteration, packaging, labels and instructions for use are subject to a 120-day period counted from publication of the alteration (run-out/use of previously approved materials), per ANVISA's official RDC 751 Q&A.

Conditions

Change outcomes are tiered by RDC 751/2022 Art. 16 and IN 74/2020: some changes implement immediately (Class I/II), others require prior approval; RDC 743/2022 Anexo sets 150-day analysis for alterations requiring approval and 30 days (tacit) for immediate-implementation notifications.

New-technology triggers refusal of alteration

change.new-application-triggers

Fact-level verified

Products with innovative technology or indication are treated distinctly: the Registro FAQ states that for such products the missing items lead to non-approval (não anuência) or summary refusal of the petition, i.e. innovation outside an existing registration requires proper application, not a simple alteration.

Conditions

Context: Registro FAQ Q5 on checklist/economic-report requirements (RDC 478/2021 economic report).

Prior authorization for changes

change.prior-authorization

Fact-level verified

Any modification of formula, composition elements or quantities, or addition, subtraction or innovation introduced in the making of a registered product requires prior and express authorization.

Conditions

Lei 6.360/1976 Art. 13, applied to devices via the RDC 751/830 alteration framework and IN 74/2020.

Registro FAQ Q7 cites Art. 13 of Lei 6.360 for device changes.

Classification rules

What local class follows from which rules and decisive product facts?

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Classes requiring registration

registration.required-classes

Fact-level verified

Classes: III
IV
Route: registration

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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DICD before class III/IV investigation

clinical-investigation.dicd-scope

Fact-level verified

The Dossiê de Investigação Clínica de Dispositivo Médico (DICD) must be submitted to ANVISA before conducting a clinical investigation involving a class III or IV device.

Conditions

RDC 837/2023 Art. 7º; Art. 4º sets the requirement for class III/IV devices without registration (§1º includes new indications).
RDC 848/2024 Art. 19 lists mandatory clinical-investigation triggers (innovative design/raw material/indication regardless of class; class III/IV with unique nature).

Effective from 2023-12-15

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Medical device definition

scope.medical-device-definition

Fact-level verified

RDC 751/2022 Art. 4º X defines 'dispositivo médico (produto médico)' broadly: any instrument, apparatus, equipment, implant, IVD, software, material or other article intended by the manufacturer for use in humans, alone or in combination.

Conditions

Full definition includes the intended medical purposes set out in the article.

Effective from 2023-03-01

Software is expressly within the definition.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Dossier structure and checklist

dossier.required-checklist

Fact-level verified

Registration dossiers follow the IMDRF Market Authorization Table of Contents (RDC 751/2022 Art. 57 and Anexo II); petitions with incomplete checklists or missing documents face summary refusal (indeferimento sumário).

Conditions

Registro FAQ Q5: petitions must be filed under the correct subject code with the checklist; missing items lead to indeferimento sumário.
Manufacturer declarations/certificates issued abroad must be no older than 2 years and apostilled (RDC 751/2022 Arts. 13-14).
Certain equipment additionally requires INMETRO certification (IN 116/2021 / RDC 549/2021) and the Economic Information Report (RDC 478/2021) per Registro FAQ Q5.

Effective from 2023-03-01

RDC 830/2023 Arts. 58 and Anexo II apply the IMDRF IVD MA ToC (N13 Edition 3 2019) for IVDs.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Local establishment authorization (AFE)

market-entry.local-role

Fact-level verified

Companies manufacturing, distributing or importing products under ANVISA's scope require ANVISA authorization to operate (Autorização de Funcionamento de Empresa - AFE), under Lei 9.782/1999 Art. 7º VII, in addition to state/local sanitary licensing.

Conditions

For custom-made devices, RDC 925/2024 Art. 5º expressly requires AFE from ANVISA plus local sanitary licensing.

Foreign manufacturers therefore act through a Brazilian holder (detentor) that holds AFE.

Holder/representative changes effective on publication

market-entry.representative-change

Fact-level verified

Alterations of an approval (including holder-related changes processed under the alteration framework and IN 74/2020) take effect only after the final decision is published in the Diário Oficial da União.

Conditions

Stated for IVDs in RDC 830/2023 Art. 21; equivalent rule for devices in RDC 751/2022 alteration provisions.
RDC 743/2022 Anexo lists 'Transferência de titularidade' with a 150-day analysis deadline.

Effective from 2024-06-01

Registration holder (detentor)

market-entry.registration-holder

Fact-level verified

The 'detentor (de notificação ou de registro)' must be a legal entity, public or private, manufacturer or importer, responsible for the device in the national territory, holding the marketing concession issued by ANVISA.

Conditions

Definition in RDC 751/2022 Art. 4º VIII; equivalent rule for IVDs in RDC 830/2023.

Effective from 2023-03-01

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Custom-made establishment licences

establishment.custom-made-licences

Fact-level verified

Manufacturers or importers of custom-made devices must hold an Autorização de Funcionamento (AFE) from ANVISA and sanitary licensing (licenciamento sanitário) from the local sanitary-surveillance authority, under Lei 6.360/1976.

Conditions

Custom-made route under RDC 925/2024 (in force on publication, DOU 24/09/2024).

Effective from 2024-09-24

Fees

What regulator fee applies to this class, route, event, and date?

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TFVS prepayment rule

fees.tfvs-prepaid

Fact-level verified

The TFVS surveillance fee (instituted by Lei 9.782/1999) must be paid before petitioning any request to ANVISA, such as registration applications; payment is by GRU, valid for 30 days from emission.

Conditions

Fee-exemption/stop-clock-type rule not expressible in the fee dataset.
TFVS values are porte-based (company revenue bands) with statutory reductions (15-95%) in Lei 9.782/1999 Anexo II Notas; exemptions include export certificates and certain petitions (TFVS page).

Collection regulated by RDC 222/2006 (amended by RDC 76/2008) per the same page; Registro FAQ Q4 cites Portaria Interministerial 701/2015.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Portuguese language requirement

language.label-and-ifu

Fact-level verified

Information on labels and in instructions for use must be written in Portuguese.

Conditions

RDC 751/2022 Art. 46 I for devices (in force from 1 March 2023); RDC 830/2023 Art. 46 I mirrors the rule for IVDs.

Effective from 2023-03-01

e-IFU is permitted with conditions (RDC 751/2022 Art. 33 §§5º-6º: SIUD upload within 30/180 days); petition labeling documents must be in Portuguese (Art. 63).

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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Current device regulation

legal-basis.rdc751-device-regulation

Fact-level verified

RDC 751/2022 is the operative medical-device regulation in force from 1 March 2023; it revoked, among others, RDC 185/2001 (Art. 66).

Conditions

Petitions governed by transition provisions of RDC 751/2022.

Effective from 2023-03-01

Art. 66 lists the revoked acts, including RDC 185/2001.

Current IVD regulation

legal-basis.rdc830-ivd-regulation

Fact-level verified

RDC 830/2023 is the operative IVD regulation (risk classification, notification/registration regimes, labeling and IFU), in force from 1 June 2024; it revoked RDC 36/2015 and other prior IVD acts (Art. 69).

Conditions

Applies to IVDs and their instruments.

Effective from 2024-06-01

Art. 69 revokes RDC 36/2015, RDC 211/2018, RDC 270/2019, RDC 340/2020, RDC 403/2020, RDC 431/2020, RDC 27/2008, IN 30/2019 and others.

Essential requirements regulation

legal-basis.rdc848-essential-requirements

Fact-level verified

RDC 848/2024 sets the essential safety and performance requirements for medical devices and IVDs; conformity is verified by the sanitary-surveillance authority at GMP inspection, at registration/notification, or at sanitary surveillance.

Conditions

In force 180 days after publication (Art. 88); revoked RDC 546/2021 (Art. 86).

Published in DOU on 8 March 2024; in force 180 days later. Art. 19 lists triggers for mandatory clinical investigation (innovations in design/raw materials/indication regardless of class; class III/IV with unique characteristics).

Primary registration statute

legal-basis.registration-requirement-statute

Fact-level verified

Under Lei 6.360/1976 Art. 12, no product subject to the law, including imports, may be manufactured, offered for sale or delivered for consumption before being registered with the Ministry of Health (functionally ANVISA).

Conditions

Base statute for all product categories under sanitary surveillance.

Art. 12 §3º (added by Lei 13.411/2016) sets a 90-day statutory decision clock (see review-clocks fact).

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Technovigilance system duty

pms.technovigilance-system

Fact-level verified

The registration holder of a health product must structure and implement a technovigilance system in its company, providing the resources for its operation (RDC 67/2009 Art. 6º, items I-XII: designated responsible staff, records of complaints and adverse events, evaluation, corrective and preventive actions).

Conditions

RDC 67/2009 remains the operative technovigilance rule for devices; RDC 925/2024 Art. 15 reaffirms RDC 67/2009 and RDC 551/2021 for custom-made devices.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Submission portal

submission.primary-system

Fact-level verified

Product petitions are filed electronically through ANVISA's Sistema de Peticionamento, identifying the applicable subject code (Código de Assunto); TFVS is paid by GRU before filing and petition status is tracked via Consulta à Situação de Documentos.

Conditions

Registro FAQ Q4 cites Portaria Interministerial nº 701/2015 for TFVS collection; ANVISA's TFVS page cites RDC 222/2006 (amended by RDC 76/2008) for the value table.

Electronic deficiency letters (exigências) are answered through the Solicita system.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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CBPF limited to class III/IV

qms.cbpf-class-iii-iv

Fact-level verified

CBPF (GMP certificate) certification is not available for class I and II health products; only class III/IV products are certifiable, so CBPF conditions class III/IV registrations.

Conditions

RDC 497/2021 Art. 18 §2º.
For IVD registration, RDC 830/2023 Art. 14 VIII accepts the CBPF petition for filing but conditions deferment on a valid certificate.

MDSAP-based certificates valid 4 years (Art. 8º §1º, RDC 850/2024).

GMP quality system (BPF)

qms.manufacturer-system

Fact-level verified

Each manufacturer must establish and maintain a quality system under RDC 665/2022, which incorporates MERCOSUL GMC Resolution 20/2011 into Brazilian law and applies to manufacturers, distributors, warehousers and importers.

Conditions

RDC 665/2022 in force from 2 May 2022; revoked RDC 16/2013 and IN 8/2013.

Effective from 2022-05-02

Art. 1º §2º: 'Esta Resolução incorpora ao ordenamento jurídico nacional a Resolução do Grupo Mercado Comum (GMC) MERCOSUL nº 20, de 17 de novembro de 2011'.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Field action trigger

fsca.field-action-trigger

Fact-level verified

The registration holder must initiate a field action as quickly as possible whenever there are sufficient indications or confirmation that a health product does not meet the applicable essential safety and efficacy requirements.

Conditions

RDC 551/2021 Art. 4; applies to health products under ANVISA registration.

Field action notification deadlines

fsca.notification-deadlines

Fact-level verified

The registration holder must notify ANVISA of field actions per RDC 551/2021 Art. 9: 3 dias corridos for actions communicated through mass media and for serious threat to public health; 10 dias for serious risk; 30 dias for other actions.

Conditions

Art. 8: alert messages via mass media require prior ANVISA anuência under Art. 41-B of Lei 9.782/1999, with a 5-dias-corridos parameter in RDC 551/2021.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Notification vs registration

pathways.notificacao-registro-split

Fact-level verified

Two market routes: class I and II devices are subject to notification (notificação) and class III and IV to registration (registro). Notifications have no technical analysis and are processed within 30 days.

Conditions

Class I/II: notification per Art. 6º; class III/IV: registration per Art. 7º.
Same split for IVDs under RDC 830/2023 Arts. 6º-7º.

Effective from 2023-03-01

RDC 751/2022 Art. 10 §§5º-6º: no technical analysis for notification petitions; notification processed within 30 days of filing.

Family/system/kit grouping

registration.grouping-options

Fact-level verified

ANVISA grants notification or registration for families, systems and sets (kits) of medical devices; grouping follows the rules of the regulation.

Conditions

Models in a family must meet the family requirements; no limit on number of models per family (Registro FAQ Q3); single-product and family processes cannot be converted after grant.

Effective from 2023-03-01

TFVS fee for family registration is higher than for a single product (Registro FAQ Q3).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Brazil approvals and evidence in other markets (14 records)

CanadaNMPA · US FDA · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS · Singapore HSA · Brazil ANVISA

Regulatory reference

Recognized foreign regulators (incorporated list)

reliance.list-of-regulatory-agencies

Fact-level verified

Health Canada maintains a List of Regulatory Agencies (around 40 authorities including US FDA, ANVISA, TGA, MHRA, PMDA/MHLW, COFEPRIS, MFDS, HSA, Swissmedic and NMPA) incorporated by reference into MDR ss.61.2 and 68.3; decisions of these agencies trigger Canada's 72-hour foreign risk notification duty.

Conditions

Applies to Class II-IV licence holders and importing MDEL holders.
Class I authorization holders excluded.

Page issued 2024-01-03, modified 2024-01-24.

ColombiaBrazil ANVISA

Prior approval / evidence record

ANVISA (Brazil)

Authority: ANVISA (Brazil)
Accepted: No
Benefit: Brazil is not on the INVIMA reference-country list and there is no device mutual recognition agreement in force
Timeline Savings: None

Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)INVIMA medical devices and biomedical equipment procedures — Formato Único numerals by risk class and the Decreto 3275/2009 homologation for reference countries

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

CubaIMDRF member authorities

Regulatory reference

Prior registration in origin/IMDRF country exempts listed evidence

reliance.imdrf-evidence-exemption

Fact-level verified

Per Article 47 of the Reglamento (acápite 3.2.4), devices with prior registration in their country of origin or in another country with a device regulatory program based on the same essential safety/efficacy requirements as the Cuban program (such as IMDRF members) are exempt from presenting: software validation report, biological pre-clinical evidence, safety/environmental/parametric test reports, raw-material certificates of analysis, and stability study. In lieu they present the Certificate of Registration of the origin country or an internationally recognized regulatory program; where the device circulates under manufacturer responsibility without registration, a manufacturer declaration plus evidence of circulation suffices.

Conditions

Foreign registration must be current at the time of the Cuban application (Proceder B requirement).

Effective from 2016-07-29

Reinforced by E 132-25 epígrafe 3.8: the CECMED will, as appropriate, take into account decisions of other regulatory authorities and regional/international bodies.

EcuadorIMDRF member authorities

Regulatory reference

IMDRF recognition for simplified registration

reliance.imdrf-simplified

Fact-level verified

From 28 January 2027, the simplified procedure requires registration from an authority that satisfies BOTH high-vigilance status and IMDRF membership (Article 31). Article 32 additionally requires device marketing in an IMDRF Management Committee country, device-scope authorisation and ARCSA risk classification I-IV. IMDRF membership alone is not sufficient, and NMPA eligibility is not established by this general rule.

Conditions

Apply both authority conditions together; the route is not in force before 2027-01-28.
Maximum 100 references for DMI/DMNI/DMA and 50 for IVD; the remaining requirements in Articles 33-34 still apply.

Effective from 2027-01-28

Recognition opens a simplified procedure; it is not a full reliance approval.

EcuadorIMDRF member authorities

Regulatory reference

Accepted Certificate of Free Sale sources

reliance.clv-sources

Fact-level verified

For imported devices, a Certificate of Free Sale (CLV) or equivalent is accepted from the country of manufacture or export, from a high-vigilance agency, or from an IMDRF member country; if the CLV or the product-owner authorization states no validity date, ARCSA considers it valid for a maximum of two years from issuance. Electronic CLVs are accepted without apostille when verifiable on the issuing authority's website.

Conditions

Applies to imported devices; CLV must state commercial name, product codes/references, manufacturer and manufacturing sites.

Effective from 2027-01-28

Current regime already requires a CLV/Certificate of Exportation for imports (2016 Art. 16.a).

MexicoNMPA · US FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS · Singapore HSA · Brazil ANVISA · IMDRF member authorities · MDSAP · WHO

Prior approval / evidence record

Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)

Name: Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
Description: The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Timeline Reduction: Resolution within a maximum of 30 working days
Eligibility: Prior authorisation by a Reference Regulatory Authority in one of the twelve IMDRF Management Committee jurisdictions: Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom, the United States
MDSAP full members are recognised for the good-manufacturing-practice certificate
Filed under homoclave COFEPRIS-04-050 rather than the ordinary COFEPRIS-04-060 registration
Post-market surveillance or technovigilance evidence from the reference market, translated into Spanish under RIS Art. 153

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)COFEPRIS ARR equivalence Lineamientos (DOF 18-07-2025) — 30 working days COFEPRIS reliance briefing — abbreviated pathway in force 30 working days after the 18-07-2025 DOF publication, ARR list, 30-working-day resolution, device homoclaves Acuerdo Anexo Uno (July 2025) — low-risk registration 20 working days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration or Equivalency

Official Timeline

Min: 35
Max: 35
Unit: days

Verification Status

official-verified

Official Source

Title: RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url: https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date: 2026-08-25

Realistic Timeline

Min: 15
Max: 31
Unit: months

With Prior Approval

Min: 8
Max: 16
Unit: months

Prior Approval Benefits

FDA 510(k)
Health Canada
Japan PMDA
IMDRF Committee Members
MDSAP

Notes

RIS Art. 179: Clase II resolved within 35 calendar days (15 days with a favourable Tercero Autorizado dictamen)
ARR equivalence route (COFEPRIS-04-050, Lineamientos DOF 18-07-2025): maximum 30 working days
Equivalency route much faster if FDA approved

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

highest

Pathway

Registration or Equivalency

Official Timeline

Min: 60
Max: 60
Unit: days

Verification Status

official-verified

Official Source

Title: RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url: https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date: 2026-08-25

Realistic Timeline

Min: 15
Max: 31
Unit: months

With Prior Approval

Min: 8
Max: 16
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA
Health Canada
Japan PMDA
IMDRF Committee Members
MDSAP

Notes

RIS Art. 179: Clase III resolved within 60 calendar days (15 days with a favourable Tercero Autorizado dictamen)
ARR equivalence route (COFEPRIS-04-050): maximum 30 working days
Equivalency pathway best option with FDA

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoIMDRF member authorities · MDSAP

Regulatory reference

Reference regulators for the abreviada route

reliance.arr-definition-devices

Fact-level verified

For medical devices, COFEPRIS recognizes as Autoridades Regulatorias de Referencia (ARR): countries that are members of the IMDRF Management Committee, and full members of the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practice certificates. Device registrations can be obtained through equivalence with prior ARR approvals via trámite COFEPRIS-04-050.

Conditions

Device and approval must fall within the current Lineamientos scope; local application and decision retained by COFEPRIS.

Effective from 2025-07-19

Effective date assumed day after DOF publication (18-07-2025) per standard transitorio wording of this type of Acuerdo; the mechanism is also described on the COFEPRIS reliance page.

PeruUS FDA · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration

Official Timeline

Min: 66
Max: 66
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA
EU CE Mark
ANVISA

Notes

TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
Technical file review required

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 44
Max: 44
Unit: working-days

Verification Status

official-verified

Official Source

Title: DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods
Url: https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 8
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

FDA 510(k)
EU CE Mark
ANVISA

Notes

TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)
CAN harmonization applies

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruBrazil ANVISA

Prior approval / evidence record

ANVISA (Brazil)

Authority: ANVISA (Brazil)
Accepted: No
Benefit: Brazil is neither a high-surveillance country under art. 9 nor a member of the Andean Community, so neither the documentary route nor CAN harmonisation applies to a Brazilian registration.
Timeline Savings: None

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods Peru D.S. 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (arts. 7 and 9, as amended)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

South AfricaAustralia TGA · Health Canada · Japan MHLW / PMDA · Brazil ANVISA · WHO

Regulatory reference

Recognised reference jurisdictions

reliance.recognised-jurisdictions

Fact-level verified

SAHPRA recognises six reference jurisdictions for reliance purposes: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification of IVDs. For Class C and D devices listed in Certificate of Free Sale applications, evidence of pre-market approval/registration or emergency use authorisation from at least one of the six jurisdictions (or WHO PQ) is required.

Conditions

Used for Class C and Class D medical devices and IVDs.
SAHPRA retains the final decision based on South African regulations.

The SAHPRA Medical Devices page confirms reliance pathways will use registrations in these recognised jurisdictions or WHO PQ.

United StatesAustralia TGA · Health Canada · Japan MHLW / PMDA · Brazil ANVISA · MDSAP

Regulatory reference

MDSAP qms audit reliance

reliance.reliance-edge-mdsap-network-qms-reuse-program-mdsap-united-states-of-america

Fact-level verified

FDA (with TGA Australia, ANVISA Brazil, Health Canada, and MHLW/PMDA Japan) participates in the Medical Device Single Audit Program and may accept MDSAP audit reports as a substitute for routine Agency inspections; firms with Electronic Product Radiation Control (EPRC) activities remain subject to direct FDA inspection for those activities.

MDSAP official documents moved to the TGA-managed MDSAP website (FDA update of 2025-12-18).

Prior approvals and evidence for Brazil (18 records)

BrazilEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: No
Benefit: Not an AREE under IN 290/2024 Art. 6
Timeline Savings: None

ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)ANVISA IN 290/2024 — optimized analysis of Class III and IV device registration petitions using an equivalent foreign regulator (AREE)ANVISA RDC 687/2022 — criteria for granting and renewing the Brazilian GMP certificate for medical devices ANVISA RDC 850/2024 — amends RDC 497/2021 Art. 8 to give MDSAP-based device GMP certificates four years of validity

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilJapan MHLW / PMDA

Prior approval / evidence record

Japan MHLW

Authority: Japan MHLW
Accepted: Yes
Benefit: Recognised AREE for IN 290/2024, evidenced by the Shonin pre-market approval
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilHealth Canada

Prior approval / evidence record

Health Canada

Authority: Health Canada
Accepted: Yes
Benefit: Recognised AREE for IN 290/2024, evidenced by the Medical Device Licence
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilUS FDA · MDSAP

Prior approval / evidence record

Class IV

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

Registration

Official Timeline

Min: 250
Max: 320
Unit: days

Verification Status

official-verified

Official Source

Title: ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date: 2026-08-25

Realistic Timeline

Min: 1
Max: 11
Unit: months

With Prior Approval

Min: 10
Max: 14
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA (via IN 290/2024)
MDSAP for B-GMP

Notes

RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days
Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice
Clinical evidence mandatory
10 year validity

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilSource authority not specified

Regulatory reference

Effect of reliance

reliance.anvisa-final-decision

Fact-level verified

Reliance does not bind ANVISA: ANVISA decides the Brazilian petition independently of the decision issued by the reference authority (AREE).

Conditions

Applies to the optimized procedure under RDC 741/2022.

Effective from 2022-09-01

BrazilJapan MHLW / PMDA

Regulatory reference

Reference authority: Japan MHLW

reliance.aree-japan-mhlw

Fact-level verified

Japan Ministry of Health, Labour and Welfare (MHLW) pre-market approval (Shonin) is the accepted Japanese reference authorization under the optimized review procedure.

Conditions

Requires authorization by at least one listed AREE and essentially identical device/indications (IN 290/2024 Art. 7º).
Applies to class III/IV primary registration petitions (IN 290/2024 Art. 2º).

Effective from 2024-06-03

Correction: the official IN 290/2024 list names only 'Japan Ministry of Health, Labour and Welfare (MHLW) - Pre-market approval (Shonin)'. PMDA and the Ninsho category are not named in the Brazilian list.

BrazilNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

Statement: ANVISA's optimized (reliance) review for Class III/IV device registration under RDC 741/2022 is available only for devices previously authorized by an AREE listed exhaustively in IN 290/2024 Art. 6: TGA (ARTG), Health Canada (Medical Device Licence), US FDA (510(k)/PMA/De Novo) and Japan MHLW (Shonin). China's NMPA is not listed, so an NMPA registration certificate gives no access to the optimized procedure and the ordinary route (RDC 751/2022 / RDC 830/2023) applies.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: brazil
China Classes In Scope: NMPA Class II/III certificates and Class I filings; target: ANVISA Class III/IV registration (optimized procedure)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Art. 7 I: device must be authorized by at least one AREE listed in Art. 6
Art. 7 II: AREE document must refer to an essentially identical device
Art. 13: ANVISA retains independent decision
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2024-06-03

Source passage: Art. 6º Para fins de adoção do procedimento otimizado de análise são consideradas as seguintes AREE e respectivas comprovações de registro ou autorização: I - Austrália: Australia Therapeutic Goods Administration (TGA) - Australian Register of Therapeutic Goods (ARTG); II - Canadá: Health Canada (HC) - Medical Device Licence; III - Estados Unidos da América (EUA): US Food and Drug Administration (US FDA) - 510(k) Clearance, Premarket Approval (PMA) ou 513(f)(2) "De Novo"; e IV - Japão: Japan Ministry of Health, Labour and Welfare (MHLW) - Pre-market approval (Shonin).

BrazilUS FDA · MDSAP

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration

Official Timeline

Min: 250
Max: 320
Unit: days

Verification Status

official-verified

Official Source

Title: ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date: 2026-08-25

Realistic Timeline

Min: 1
Max: 11
Unit: months

With Prior Approval

Min: 8
Max: 12
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA (via IN 290/2024)
MDSAP for B-GMP

Notes

RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days
Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice
B-GMP certificate mandatory
10 year validity

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilMDSAP

Prior approval / evidence record

MDSAP B-GMP validity extension (RDC 850/2024)

Name: MDSAP B-GMP validity extension (RDC 850/2024)
Description: RDC 497/2021 Art. 8 gives a Brazilian GMP certificate two years. RDC 850/2024 added a first paragraph doubling that to four years where the certificate was granted through MDSAP, conditional on the manufacturer staying in MDSAP for the whole certificate period.
Timeline Reduction: 4 years of B-GMP validity instead of 2, so one renewal cycle removed
Eligibility: Manufacturer participates in MDSAP
Participation maintained throughout the validity of the certificate

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilNMPA

Prior approval / evidence record

NMPA-ANVISA cooperation MoU (2020): no recognition effect

reliance.china-nmpa-bilateral-programme

Pending verification

Statement: NMPA Commissioner Jiao Hong and ANVISA Director-President Antonio Barra Torres signed a Memorandum of Understanding on cooperation on 26 November 2020 covering information exchange in the regulation of drugs, medical devices and cosmetics. ANVISA's official cooperation page lists the 'Memorando de Entendimento entre Anvisa e NMPA' under China, and a separate BRICS regulators' MoU. Neither instrument creates recognition of NMPA registrations; they are information-exchange frameworks.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: brazil
China Classes In Scope: All device classes (framework MoU; no product-level effect)
Edge Type: Cooperation Mou
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Information exchange only; no reliance or mutual recognition of registrations
ANVISA also lists a BRICS (RU/IN/CN/ZA) regulators' MoU
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2020-11-26

Source passage: The National Medical Products Administration (NMPA) Commissioner Jiao Hong signed a memorandum of understanding (MoU) on cooperation with Antonio Barra Torres, head of the Brazilian health regulatory agency ... on Nov 26. ... have agreed to further strengthen information exchanges in regulation of drugs, medical devices and cosmetics under the framework of the MoU

BrazilMDSAP

Regulatory reference

MDSAP audit reuse (GMP)

reliance.mdsap-cbpf-validity

Fact-level verified

GMP reliance: a CBPF certificate based on an audit performed under the Medical Device Single Audit Program (MDSAP) is valid for 4 years, versus 2 years for the standard certificate.

Conditions

RDC 497/2021 Art. 8º §1º, inserted by RDC 850/2024 (20 March 2024).
ANVISA's Confiança Regulatória page additionally lists MDSAP auditing organizations and MERCOSUL member-state authorities as reference authorities for GMP.

Effective from 2024-03-20

CBPF renewal petition window: between 270 and 180 days before certificate expiry (Art. 37), with renewal granted automatically if ANVISA does not decide (Arts. 38-39).

BrazilAustralia TGA

Regulatory reference

Reference authority: Australia TGA

reliance.aree-au-tga

Fact-level verified

Australia Therapeutic Goods Administration (TGA) listing on the Australian Register of Therapeutic Goods (ARTG) is accepted under the optimized review procedure for class III/IV device registration.

Conditions

Requires authorization by at least one listed AREE and essentially identical device/indications (IN 290/2024 Art. 7º).
IN 290/2024 Art. 2º: applies to class III/IV primary registration petitions.
ANVISA decides independently (RDC 741/2022 Art. 13).

Effective from 2024-06-03

Framework: RDC 741/2022 (in force 1 September 2022) + IN 290/2024 (in force 3 June 2024).

BrazilMDSAP

Prior approval / evidence record

MDSAP

Authority: MDSAP
Accepted: Yes
Benefit: Audit reports substitute for the inspection report at B-GMP certification and extend the certificate to 4 years, but RDC 687/2022 Art. 14 keeps ANVISA free to inspect on site at any time, including during the certificate validity
Timeline Savings: Removes the wait for an ANVISA inspection slot

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilUS FDA

Regulatory reference

Reference authority: US FDA

reliance.aree-us-fda

Fact-level verified

US FDA marketing authorizations accepted under the optimized review procedure: 510(k) Clearance, Premarket Approval (PMA), or 513(f)(2) De Novo.

Conditions

Requires authorization by at least one listed AREE and essentially identical device/indications (IN 290/2024 Art. 7º).
Applies to class III/IV primary registration petitions (IN 290/2024 Art. 2º).
ANVISA decides independently (RDC 741/2022 Art. 13).

Effective from 2024-06-03

BrazilHealth Canada

Regulatory reference

Reference authority: Health Canada

reliance.aree-health-canada

Fact-level verified

Health Canada Medical Device Licence is accepted under the optimized review procedure for class III/IV device registration.

Conditions

Requires authorization by at least one listed AREE and essentially identical device/indications (IN 290/2024 Art. 7º).
Applies to class III/IV primary registration petitions (IN 290/2024 Art. 2º).
ANVISA decides independently (RDC 741/2022 Art. 13).

Effective from 2024-06-03

BrazilUS FDA

Prior approval / evidence record

FDA 510(k)/PMA/De Novo

Authority: FDA 510(k)/PMA/De Novo
Accepted: Yes
Benefit: Recognised AREE for IN 290/2024 optimized analysis of Class III and IV registrations
Timeline Savings: None published — Art. 10 preserves queue position

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilUS FDA · Australia TGA · Health Canada · Japan MHLW / PMDA · Brazil ANVISA

Prior approval / evidence record

Optimized analysis (procedimento otimizado, IN 290/2024)

Name: Optimized analysis (procedimento otimizado, IN 290/2024)
Description: ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.
Timeline Reduction: No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
Eligibility: Class III and IV primary registration petitions only, medical devices and IVDs (Art. 2)
Prior authorisation by one of the four recognised AREE: TGA via the ARTG, Health Canada via a Medical Device Licence, US FDA via 510(k), PMA or De Novo, or Japan MHLW via Shonin (Art. 6)
The device must be essentially identical to the one the AREE authorised, down to composition, indications, manufacturer and manufacturing process (Art. 5 II)
Excluded if the AREE itself granted the authorisation through an abbreviated route similar to ANVISA optimized analysis (Art. 4)
Filed as a secondary aditamento petition; omit it and the registration is analysed by the ordinary route (Art. 11)
ANVISA keeps the right to revert to ordinary analysis with reasons (Art. 9) and to decide differently from the AREE (Art. 13)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BrazilAustralia TGA

Prior approval / evidence record

TGA (Australia)

Authority: TGA (Australia)
Accepted: Yes
Benefit: Recognised AREE for IN 290/2024, evidenced by the ARTG entry
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Statutory registration clock

clocks.statutory-90-days

Fact-level verified

Statutory rule (Lei 6.360/1976 Art. 12 §3º, added by Lei 13.411/2016): registration must be granted within a maximum of 90 days from filing of the request, save cases of non-compliance (deficiencies).

Conditions

Operative case-by-case deadlines are set by RDC 743/2022 (Anexo) for devices/IVDs; notifications are processed in 30 days without technical analysis.

Tacit approval rule

clocks.tacit-approval

Fact-level verified

If ANVISA does not issue a conclusive manifestation by the regulatory deadline for an act whose outcome releases ANVISA from responsibility, the act is tacitly approved, except for the situations listed in the Anexo of RDC 743/2022 (e.g. initial registration of risk III materials is expressly excluded from tacit approval).

Conditions

RDC 743/2022 Art. 2º parágrafo único and Anexo.
Tacit renewal of registrations exists separately via RDC 250/2004 Art. 1º.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Custom-made anuência lead time

special-access.custom-made-first-device-lead-time

Fact-level verified

The ANVISA anuência for manufacturing/importing a custom-made device must be requested at least 30 days in advance.

Conditions

RDC 925/2024 Art. 9 §1º.

Effective from 2024-09-24

Custom-made route

special-access.custom-made-route

Fact-level verified

Custom-made devices do not require registration under RDC 751/2022 but remain subject to prior sanitary control through ANVISA anuência to manufacture/import and to manufacture/import notification.

Conditions

RDC 925/2024 Art. 4; in force on publication (DOU 24/09/2024); revoked RDC 305/2019 and RDC 562/2021.
Class III/IV custom-made devices additionally require CBPF (RDC 925/2024 Art. 7).

Effective from 2024-09-24

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Administrative appeal structure

appeals.recurso-anvisa

Fact-level verified

From acts practiced by ANVISA an appeal (recurso) lies to the Diretoria Colegiada, with suspensive effect, as the last administrative instance (Lei 9.782/1999 Art. 15 §2º); the appeal is filed within 30 days of publication/intimação (§3º) and decided within 90 days, prorrogable (§4º). Under RDC 266/2019 the second instance is the Gerência-Geral de Recursos (GGREC) and the last is the Diretoria Colegiada - Dicol.

Conditions

The general federal rule of Lei 9.784/1999 Art. 59 is 10 days for administrative appeals; the ANVISA-specific 30-day rule governs.
Per the Recursos FAQ (Q15), the final decision of each appellate instance on filing is published within a maximum of 90 days, prorrogable once for an equal period with justification.

Recursos FAQ: 'recurso administrativo à Gerência-Geral de Recursos – GGREC, no prazo de 30 (trinta) dias após a ciência do indeferimento, conforme preceitua a RDC nº 266/2019'. Device recurso subject codes: 883 (material), 80038 (equipamento), 8412 (IVD).

Deficiency response deadline

submission.exigencia-120-days

Fact-level verified

Technical deficiency letters (exigência técnica) under RDC 204/2005 must be answered within 120 days, non-extendable, counted from confirmation of receipt of the exigência; non-compliance results in refusal (indeferimento) of the petition (Art. 11).

Conditions

30 days, non-extendable, for petitions related to import processes (Art. 6º §2º).
RDC 205/2017 item VI: compliance within 30 days after reading the notification, for certain procedures (clinical-trial anuência, CBPF, registration of medicines for rare diseases).
Missing checklist documents are not exigência-eligible and lead directly to indeferimento (Art. 2º, per the Exigência FAQ).

The clock runs from reading the notification in the Sistema de Peticionamento/Caixa Postal; non-attendance of any formal requirement leads to archiving under Lei 9.784/1999 Art. 40 ('implicará arquivamento do processo').

Electronic exigência channel (Solicita)

submission.exigencia-solicita

Fact-level verified

Since 17 February 2021, electronic deficiency letters that would previously be answered in the Sistema de Peticionamento Eletrônico must be answered through the Solicita system.

Conditions

Delivery via Caixa Postal Eletrônica and registered e-mail; no partial compliance is accepted (Exigência FAQ).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

UDI assignment and issuing entities

udi.premarket-assignment

Fact-level verified

Manufacturers must ensure UDI assignment to all devices manufactured by them or on their behalf (RDC 591/2021 Arts. 8º-9º); UDIs are assigned by the issuing entities GS1, HIBCC and ICCBBA (Art. 11 parágrafo único), and UDI data must accompany notification/registration petitions.

Conditions

Custom-made devices are outside the UDI scope (Art. 2).
RDC 591/2021 Art. 10: UDI required in adverse-event/technical-complaint/field-action notifications.

Effective from 2022-01-10

UDI system components

udi.system-components

Fact-level verified

The UDI is a standards-based unique device identifier (converted using AIDC and, where applicable, HRI), whose UDI-DI is also linked to a UDI database (SIUD).

Conditions

RDC 591/2021 Art. 7º; in force from 10 January 2022.

Effective from 2022-01-10

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Incident reporting deadlines

vigilance.reporting-deadlines

Fact-level verified

Under RDC 67/2009 Art. 8º (consolidated text, as amended): death, serious threat to public health, or counterfeiting associated with a product registered in the holder's name must be reported within 72 hours (corridas); other occurrences, including serious adverse events not resulting in death and technical complaints with potential for death or serious adverse event, within 10 days (corridas); technical complaints within 30 days; events occurring abroad involving foreign-registered products within 10 days.

Conditions

Deadlines run from knowledge of the occurrence; reports via ANVISA's electronic system (Art. 11).

Related structured datasets

Classification systems · 1 record

Open Risk classes I through IV for general devices and IVDs. →

brazil:medical-device

Jurisdiction Id

brazil

Domains

medical-device
ivd

Name

Risk classes I through IV for general devices and IVDs.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
high
Id
iv
Label
Class IV
Normalized Risk Level
highest

Regulator

ANVISA

Official Domains

gov.br
anvisa.gov.br

Source Status

official-source-verified

Source Title

ANVISA RDC 751/2022 English translation

Source Url

https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf

Verified On

2026-08-13

Source Supports

class-axis
classification-rules
ivd-class-axis
ivd-classification-rules

Notes

Devices classify via 22 rules in Anexo I of RDC 751/2022 (IMDRF/GHTF-derived); IVDs classify into classes I-IV via 8 rules in Anexo I of RDC 830/2023 (Art. 5º). Classes I/II route to notification and III/IV to registration (Arts. 6º-7º RDC 751/2022). Re-confirmed 2026-08-25 against the ANVISA legislative text (anvisalegis.datalegis.net).

Registration pathways, prior approvals and planning · 1 record

Open Brazil registration →

Country

Brazil

Jurisdiction Id

brazil

Country Code

Flag

🇧🇷

Regulator

Agência Nacional de Vigilância Sanitária

Regulator Abbrev

ANVISA

Region

americas

Tier

Risk Classification

4-class (I, II, III, IV)

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Notification
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date
2026-08-25
Realistic Timeline
Min
1
Max
1.5
Unit
months
Notes
Notificação decided within 30 days (RDC 743/2022 Anexo)
No ANVISA review of technical merit
Unlimited validity
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-ii
Class Name
Class II
Risk Level
medium
Pathway
Notification
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date
2026-08-25
Realistic Timeline
Min
1
Max
1.5
Unit
months
Notes
Notificação decided within 30 days (RDC 743/2022 Anexo)
Unlimited validity
INMETRO certification adds 3-12 months if required
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-iii
Class Name
Class III
Risk Level
high
Pathway
Registration
Official Timeline
Min
250
Max
320
Unit
days
Verification Status
official-verified
Official Source
Title
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date
2026-08-25
Realistic Timeline
Min
1
Max
11
Unit
months
With Prior Approval
Min
8
Max
12
Unit
months
Prior Approval Benefits
FDA 510(k)/PMA (via IN 290/2024)
MDSAP for B-GMP
Notes
RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days
Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice
B-GMP certificate mandatory
10 year validity
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-iv
Class Name
Class IV
Risk Level
highest
Pathway
Registration
Official Timeline
Min
250
Max
320
Unit
days
Verification Status
official-verified
Official Source
Title
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date
2026-08-25
Realistic Timeline
Min
1
Max
11
Unit
months
With Prior Approval
Min
10
Max
14
Unit
months
Prior Approval Benefits
FDA 510(k)/PMA (via IN 290/2024)
MDSAP for B-GMP
Notes
RDC 743/2022 Anexo: equipment registration 250 days, materials Risk III registration 320 days (no tacit approval for Risk III materials), IVD 365 days
Lei 6.360/1976 Art. 12 §3º separately binds ANVISA to 90 days for health-product petitions — RDC 743 subject-specific clocks govern in practice
Clinical evidence mandatory
10 year validity
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes

Expedited Pathways

Name
Optimized analysis (procedimento otimizado, IN 290/2024)
Description
ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.
Timeline Reduction
No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
Eligibility
Class III and IV primary registration petitions only, medical devices and IVDs (Art. 2)
Prior authorisation by one of the four recognised AREE: TGA via the ARTG, Health Canada via a Medical Device Licence, US FDA via 510(k), PMA or De Novo, or Japan MHLW via Shonin (Art. 6)
The device must be essentially identical to the one the AREE authorised, down to composition, indications, manufacturer and manufacturing process (Art. 5 II)
Excluded if the AREE itself granted the authorisation through an abbreviated route similar to ANVISA optimized analysis (Art. 4)
Filed as a secondary aditamento petition; omit it and the registration is analysed by the ordinary route (Art. 11)
ANVISA keeps the right to revert to ordinary analysis with reasons (Art. 9) and to decide differently from the AREE (Art. 13)
Name
MDSAP B-GMP validity extension (RDC 850/2024)
Description
RDC 497/2021 Art. 8 gives a Brazilian GMP certificate two years. RDC 850/2024 added a first paragraph doubling that to four years where the certificate was granted through MDSAP, conditional on the manufacturer staying in MDSAP for the whole certificate period.
Timeline Reduction
4 years of B-GMP validity instead of 2, so one renewal cycle removed
Eligibility
Manufacturer participates in MDSAP
Participation maintained throughout the validity of the certificate

Prior Approvals

Authority
FDA 510(k)/PMA/De Novo
Accepted
Yes
Benefit
Recognised AREE for IN 290/2024 optimized analysis of Class III and IV registrations
Timeline Savings
None published — Art. 10 preserves queue position
Authority
EU CE Mark
Accepted
No
Benefit
Not an AREE under IN 290/2024 Art. 6
Timeline Savings
None
Authority
MDSAP
Accepted
Yes
Benefit
Audit reports substitute for the inspection report at B-GMP certification and extend the certificate to 4 years, but RDC 687/2022 Art. 14 keeps ANVISA free to inspect on site at any time, including during the certificate validity
Timeline Savings
Removes the wait for an ANVISA inspection slot
Authority
TGA (Australia)
Accepted
Yes
Benefit
Recognised AREE for IN 290/2024, evidenced by the ARTG entry
Timeline Savings
None published
Authority
Health Canada
Accepted
Yes
Benefit
Recognised AREE for IN 290/2024, evidenced by the Medical Device Licence
Timeline Savings
None published
Authority
Japan MHLW
Accepted
Yes
Benefit
Recognised AREE for IN 290/2024, evidenced by the Shonin pre-market approval
Timeline Savings
None published

Key Requirements

Brazil Registration Holder (BRH) - mandatory for foreign manufacturers
B-GMP certificate (Class III & IV)
Portuguese labeling and IFU
Clinical evidence (Class III & IV)
UDI (phased: Class IV Jul 2025, Class III Jan 2026)
Post-registration clocks: revalidação decided within 180 days (silence = approval); alteração (changes) within 150 days

Local Rep Required

Yes

Local Rep Name

Brazil Registration Holder (BRH)

Mdsap Accepted

Yes

Mdsap Benefit

MDSAP audit reports stand in for the inspection report when ANVISA grants or renews the B-GMP certificate, and RDC 850/2024 extends that certificate to 4 years for as long as the manufacturer stays in the programme. It is not an inspection waiver: RDC 687/2022 Art. 14 lets ANVISA inspect on site at any time, and refusing an inspection cancels the certificate.

Registration Validity

Unlimited (Class I-II), 10 years (Class III-IV)

Verification Status

official-verified

Official Sources

Title
ANVISA RDC 743/2022 — analysis deadlines per subject and act (Anexo)
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000743&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_modulo=310&cod_menu=9434
Accessed Date
2026-08-25
Title
ANVISA IN 290/2024 — optimized analysis of Class III and IV device registration petitions using an equivalent foreign regulator (AREE)
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=INM&numeroAto=00000290&seqAto=000&valorAno=2024&orgao=DC/ANVISA/MS&cod_menu=1696&cod_modulo=134
Effective Date
2024-06-03
Accessed Date
2026-08-30
Title
ANVISA RDC 687/2022 — criteria for granting and renewing the Brazilian GMP certificate for medical devices
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000687&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&cod_menu=1696&cod_modulo=134
Effective Date
2022-06-01
Accessed Date
2026-08-30
Title
ANVISA RDC 850/2024 — amends RDC 497/2021 Art. 8 to give MDSAP-based device GMP certificates four years of validity
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000850&seqAto=000&valorAno=2024&orgao=RDC/DC/ANVISA/MS&cod_menu=1696&cod_modulo=134
Effective Date
2024-04-01
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

brazil

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Device Classification
Description
Classify device under ANVISA RDC 751/2022 (Class I, II, III, or IV).
Duration
2-4 weeks
Icon
🏷️
Step
2
Title
Appoint BRH
Description
Foreign manufacturers must appoint a Brazil Registration Holder (BRH) for registration.
Duration
4-8 weeks
Icon
🏛️
Step
3
Title
GMP Certificate
Description
Obtain ANVISA B-GMP certificate or MDSAP certificate covering Brazil. Facility audit required.
Duration
6-12 months
Icon
🏭
Step
4
Title
Technical Documentation
Description
Prepare ANVISA-compliant technical dossier. Portuguese translation required.
Duration
2-4 months
Icon
📋
Step
5
Title
ANVISA Submission
Description
BRH submits registration application to ANVISA via electronic system.
Duration
1-2 weeks
Icon
📤
Step
6
Title
ANVISA Review
Description
ANVISA conducts technical review. IN 290/2024 offers faster pathway with FDA/EU/TGA approval.
Duration
6-18 months
Icon
⚙️
Step
7
Title
Registration
Description
ANVISA issues registration. Valid 10 years (or 5 years without MDSAP).
Duration
2-4 weeks
Icon
✅

Government fee schedules · 1 record

Open Brazil fees →

Jurisdiction Id

brazil

Country

Brazil

Country Code

Authority

ANVISA

Low Risk Local

Min: 175.72
Max: 3514.32
Currency: BRL
Per Product: Yes

High Risk Local

Min: 780.96
Max: 49641.2
Currency: BRL
Per Product: Yes

Details

Id
notification-class-i-ii
Item
Class I/II notification (fato gerador 752)
Currency
BRL
Amount Local
3514.32
Amount Local Min
175.72
Amount Local Max
3514.32
Amount Local Formatted
BRL 175.72–3,514.32
Frequency
Per notification
Notes
Exact payable amount depends on the ANVISA-recognized company-size group.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
registration-medium-small-device
Item
Class III/IV registration — medium/small device (731)
Currency
BRL
Amount Local
15619.2
Amount Local Min
780.96
Amount Local Max
15619.2
Amount Local Formatted
BRL 780.96–15,619.20
Frequency
Per registration
Notes
Single device; range is microenterprise through Group I large enterprise.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
registration-medium-small-family
Item
Class III/IV registration — medium/small family (733)
Currency
BRL
Amount Local
21274.8
Amount Local Min
1063.74
Amount Local Max
21274.8
Amount Local Formatted
BRL 1,063.74–21,274.80
Frequency
Per family registration
Notes
Range is microenterprise through Group I large enterprise.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
registration-large-device
Item
Class III/IV registration — large equipment (730)
Currency
BRL
Amount Local
39048
Amount Local Min
1952.4
Amount Local Max
39048
Amount Local Formatted
BRL 1,952.40–39,048.00
Frequency
Per registration
Notes
Large diagnostic or therapeutic equipment; range depends on company size.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
registration-large-family
Item
Class III/IV registration — large-equipment family (732)
Currency
BRL
Amount Local
49641.2
Amount Local Min
2482.06
Amount Local Max
49641.2
Amount Local Formatted
BRL 2,482.06–49,641.20
Frequency
Per family registration
Notes
Range is microenterprise through Group I large enterprise.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
renewal-medium-small-device
Item
Registration renewal — medium/small device (735)
Currency
BRL
Amount Local
14057.28
Amount Local Min
702.86
Amount Local Max
14057.28
Amount Local Formatted
BRL 702.86–14,057.28
Frequency
Per renewal
Notes
The Annex already includes the renewal discount and company-size reductions.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
renewal-medium-small-family
Item
Registration renewal — medium/small family (736)
Currency
BRL
Amount Local
19147.32
Amount Local Min
957.37
Amount Local Max
19147.32
Amount Local Formatted
BRL 957.37–19,147.32
Frequency
Per family renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
renewal-large-device
Item
Registration renewal — large equipment (734)
Currency
BRL
Amount Local
35143.2
Amount Local Min
1757.16
Amount Local Max
35143.2
Amount Local Formatted
BRL 1,757.16–35,143.20
Frequency
Per renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
renewal-large-family
Item
Registration renewal — large-equipment family (737)
Currency
BRL
Amount Local
44677.08
Amount Local Min
2233.85
Amount Local Max
44677.08
Amount Local Formatted
BRL 2,233.85–44,677.08
Frequency
Per family renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
post-registration-change
Item
Post-registration change or inclusion (738)
Currency
BRL
Amount Local
3514.32
Amount Local Min
175.72
Amount Local Max
3514.32
Amount Local Formatted
BRL 175.72–3,514.32
Frequency
Per petition
Notes
Labeling/instructions-only changes under fact generator 742 are exempt.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
cbpf-brazil-mercosur
Item
GMP certification — Brazil or Mercosur site (726)
Currency
BRL
Amount Local
26593.5
Amount Local Min
1329.68
Amount Local Max
26593.5
Amount Local Formatted
BRL 1,329.68–26,593.50
Frequency
Per site and production line
Notes
Company-size discounts apply.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25
Id
cbpf-other-country
Item
GMP certification — site outside Mercosur (727)
Currency
BRL
Amount Local
72804.9
Amount Local Formatted
BRL 72,804.90
Frequency
Per site and production line
Notes
RDC 857/2024 excludes non-Mercosur GMP certification from company-size discounts.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Source Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Source Effective Date
2024-06-03
Verified On
2026-08-25

Notes

RDC 857/2024 Annex I publishes six exact TFVS amounts for each applicable fact generator: Group I/II large, Group III/IV medium, small, and microenterprise.
The displayed range is the official microenterprise-to-Group-I range, not an estimate. Without accepted proof of size, ANVISA assigns Group I and charges the maximum.
Registration and GMP certification are separate charges; foreign-site GMP is manufacturer/site-level rather than per device.
Statutory basis: Lei 9.782/1999 Anexo II (MP 2.190-34/2001) items 7.1-7.7 — AFE fabricante R$ 10,000 / distribuidora-importadora R$ 8,000 / varejista R$ 5,000; CBPF and CBPD/A R$ 15,000/ano; registro grande porte R$ 20,000 per 5 years and outros R$ 8,000; família grande porte R$ 28,000 and outros R$ 12,000; alteração R$ 1,800; certificado de exportação exempt; statutory porte reductions of 15/30/60/90/95% by company size. ANVISA’s TFVS page states collection follows RDC 222/2006 (amended by RDC 76/2008) Anexo I, so the Anexo II figures are the statutory basis rather than necessarily the currently collected values. GRU must be paid before petitioning and is valid 30 days.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
ANVISA RDC 857/2024, Annex I TFVS fee matrix
Url
https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&codTipo=&cod_menu=1696&cod_modulo=134&desItem=&desItemFim=&numeroAto=00000857&orgao=RDC%2FDC%2FANVISA%2FMS&pesquisa=true&seqAto=000&tipo=RDC&valorAno=2024
Effective Date
2024-06-03
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Brazil certifications →

Slug

brazil

Market

Brazil

Confidence

high

Schemes

Id
inmetro-sbac-conformity-certificate
Name
INMETRO/SBAC conformity certificate
Category
Medical Electrical Safety
Status
Mandatory If Feature
Object
Covered Electromedical Or Listed Product
Note
ANVISA Registro FAQ Q5 directs to INMETRO IN 116/2021 and RDC 549/2021 for compulsory certification of certain electromedical equipment (electrical safety).
Source Urls
https://www.gov.br/inmetro/pt-br/acesso-a-informacao/perguntas-frequentes/avaliacao-da-conformidade/equipamentos-sob-regime-de-vigilancia-sanitaria/como-certifico-um-produtos-sob-vigilancia-sanitaria
Source Binding
candidate
Id
anatel-certification-and-homologation
Name
ANATEL certification and homologation
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Or Telecommunications Product
Source Urls
https://www.gov.br/anatel/pt-br/regulado/certificacao-de-produtos
Source Binding
candidate
Id
inmetro-legal-metrology-type-approval-verification
Name
INMETRO legal-metrology type approval/verification
Category
Legal Metrology
Status
Mandatory If Feature
Object
Regulated Measuring Instrument
Source Urls
https://www.gov.br/inmetro/pt-br/assuntos/vigilancia-de-mercado/fiscalizaveis/instrumentos-de-medicao
Source Binding
candidate
Id
ansn-cnen-radiation-import-transfer-use-authorization
Name
ANSN/CNEN radiation import/transfer/use authorization
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Radiation Equipment Source And Use Site
Source Urls
https://www.gov.br/ansn/pt-br/servicos/instalacoes-radioativas/requerimentos-e-tlc
Source Binding
candidate
Id
anvisa-sbac-product-specific-conformity
Name
ANVISA/SBAC product-specific conformity
Category
Product Specific Conformity
Status
Mandatory If Feature
Object
Listed Product Category
Note
RDC 848/2024 Art. 1 §3: essential safety and performance requirements are verified by the sanitary authority at GMP inspection, registration/notification or surveillance; labelling may use ABNT NBR ISO 15223 symbols (RDC 830/2023 Art. 46 VI).
Source Urls
https://www.gov.br/anvisa/en/regulation-of-products/medical-devices
Source Binding
candidate

Official Sources

Authority
ANVISA
Topic
medical devices and compulsory conformity
Url
https://www.gov.br/anvisa/en/regulation-of-products/medical-devices
Authority
INMETRO
Topic
health-surveillance equipment certification
Url
https://www.gov.br/inmetro/pt-br/acesso-a-informacao/perguntas-frequentes/avaliacao-da-conformidade/equipamentos-sob-regime-de-vigilancia-sanitaria/como-certifico-um-produtos-sob-vigilancia-sanitaria
Authority
ANATEL
Topic
telecommunications product certification
Url
https://www.gov.br/anatel/pt-br/regulado/certificacao-de-produtos
Authority
INMETRO
Topic
legal metrology instruments
Url
https://www.gov.br/inmetro/pt-br/assuntos/vigilancia-de-mercado/fiscalizaveis/instrumentos-de-medicao
Authority
ANSN/CNEN
Topic
radiation installation and equipment requests
Url
https://www.gov.br/ansn/pt-br/servicos/instalacoes-radioativas/requerimentos-e-tlc
Authority
ANVISA
Topic
product registration FAQ INMETRO IN 116/2021 and RDC 549/2021 checklist
Url
https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/registro/registro-de-produtos

Need to apply Brazil's requirements to a product?

Confirm the current ANVISA pathway, evidence, and local-role details for the actual device before filing.

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