ANVISA market accessResearch ANVISA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Brazil medical device resource.
Search official ANVISA device registration records.
Paste company and product facts and download an AI-prepared copy of the official Class III and IV registration Word form.
Prepare a draft of ANVISA Ficha de Enquadramento V2 from pasted company and product information.
Extract commercial models from pasted portfolio text and populate ANVISA’s official Excel template.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official ANVISA regulations and guidance documents.
Compare official and realistic approval times by device class and pathway.
Review current ANVISA application, review, and renewal fees.
Estimate the likely ANVISA pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent ANVISA policy, guidance, and compliance updates.
Describe your device and get a preliminary ANVISA risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Brazil requirements.
Describe a device and find comparable products in the ANVISA registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
25 of 25 research dimensions currently covered · 31 official sources · latest verification 2026-09-07
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 |
Agência Nacional de Vigilância Sanitária (ANVISA) review clocks and planning ranges · 4-class (I, II, III, IV) classification
Newest official ANVISA headlines from the daily-refreshed feed — every row links directly to the authority publication.
BrazilAug 27ANANVISASmart Rings Should Not Be Used to Diagnose Diseases, ANVISA WarnsBrazilAug 25ANANVISAAnvisa Orders Seizure of Counterfeit Collagen BiostimulatorsBrazilAug 25ANANVISAAnvisa Releases Guidance Manuals for Medical Device Registration and NotificationBrazilAug 14ANANVISARegistration of international manufacturers of medical devices (Risk I and II) is now electronicBrazilOfficial ANVISA rules and guidance · 16 of 16 documents linked to official sources
Computed from 100,149 official ANVISA registration records · data as of 2026-08-26
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Brazil work.
Connect the ANVISA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against ANVISA administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to ANVISA evidence, notification, timing, and implementation questions.
Assess a current ANVISA update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Brazil (ANVISA).
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