ANVISA · Americas

Brazil medical device regulatory resources

Every Brazil dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

100,149 registration records14 free resources24/25 topics with records16 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official ANVISA device registration records.

ANVISA RDC 751 registration form filler

Paste company and product facts and download an AI-prepared copy of the official Class III and IV registration Word form.

ANVISA classification form filler

Prepare a draft of ANVISA Ficha de Enquadramento V2 from pasted company and product information.

ANVISA model list spreadsheet filler

Extract commercial models from pasted portfolio text and populate ANVISA’s official Excel template.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official ANVISA regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current ANVISA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely ANVISA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent ANVISA policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary ANVISA risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Brazil requirements.

AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 52 source-linked facts →

24 of 25 research dimensions currently covered · 32 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: 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…
Statutory product scope: 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 imag…

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

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

4 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical device definition: 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 manufac…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I through IV for general devices and IVDs.: Class I, Class II, Class III, Class IV

1 maintained scheme · 1 related fact

Checked 2026-08-24

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D05

Registration pathways

Verified

Notification vs registration: 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 process…
Family/system/kit grouping: ANVISA grants notification or registration for families, systems and sets (kits) of medical devices; grouping follows the rules of the regulation.

2 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Effect of reliance: Reliance does not bind ANVISA: ANVISA decides the Brazilian petition independently of the decision issued by the reference authority (AREE).
Reference authority: Australia TGA: 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 regi…

8 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Local establishment authorization (AFE): 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…
Holder/representative changes effective on publication: 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 Of…

3 source-linked facts

Checked 2026-08-26

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D08

Establishment, import & distribution

Verified

Custom-made establishment licences: 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 survei…

1 source-linked fact

Checked 2026-08-25

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D09

Dossier requirements

Verified

Dossier structure and checklist: 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 ref…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

Submission portal: 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 pet…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

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

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

CBPF limited to class III/IV: 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.
GMP quality system (BPF): 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, distri…

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

INMETRO/SBAC conformity certificate: Electrical safety
ANATEL certification and homologation: Wireless / radio
INMETRO legal-metrology type approval/verification: Metrology

5 maintained overlays

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D14

Fees

Verified

Class I/II notification (fato gerador 752): BRL 175.72–3,514.32
Class III/IV registration — medium/small device (731): BRL 780.96–15,619.20

12 maintained fee lines · 1 related fact

Checked 2026-08-25

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D15

Review clocks

Verified

Class I · Notification: 30 days
Class II · Notification: 30 days
Class III · Registration: 250-320 days

4 maintained pathways · 2 related facts

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

IVD registration validity: IVD registrations are likewise valid for 10 years counted from publication in the Diário Oficial da União.
Automatic revalidation at lapse: If ANVISA has not decided the revalidation petition by the registration expiry date, the registration is automatically revalidated, regardless of a decision.

4 source-linked facts

Checked 2026-08-26

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Lifecycle & post-market

D17

Change control

Verified

Post-change packaging run-out: 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)…
New-technology triggers refusal of alteration: 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 ref…

3 source-linked facts

Checked 2026-08-26

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D18

UDI, listing & traceability

Verified

UDI assignment and issuing entities: 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 (…
UDI system components: 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).

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

DICD before class III/IV investigation: 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.

1 source-linked fact

Checked 2026-08-25

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D20

Special access & derogation

Verified

Custom-made anuência lead time: The ANVISA anuência for manufacturing/importing a custom made device must be requested at least 30 days in advance.
Custom-made route: 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 notif…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Technovigilance system duty: 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…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Incident reporting deadlines: 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 report…

1 source-linked fact

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Field action trigger: 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 esse…
Field action notification deadlines: 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…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Mandatory alert advertising: 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 th…
Advertising concordance rule: 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…

3 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Administrative appeal structure: 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 fi…
Deficiency response deadline: 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 r…

3 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (12 lines) →

ANVISA registration fees in BRL · reviewed 2026-08-25

Fee line	Amount	Provenance
Class I/II notification (fato gerador 752)	BRL 175.72–3,514.32	Verified
Class III/IV registration — medium/small device (731)	BRL 780.96–15,619.20	Verified
Class III/IV registration — medium/small family (733)	BRL 1,063.74–21,274.80	Verified
Class III/IV registration — large equipment (730)	BRL 1,952.40–39,048.00	Verified

8 more fee lines on the full schedule · 12 of 12 rows source-verified

Registration timeline

Full registration timeline →

Agência Nacional de Vigilância Sanitária (ANVISA) review clocks and planning ranges · 4-class (I, II, III, IV) classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Notification)	30 days	1-1.5 months	Verified
Class II(Notification)	30 days	1-1.5 months	Verified
Class III(Registration)	250-320 days	1-11 months	Verified
Class IV(Registration)	250-320 days	1-11 months	Verified