Typical timeline
6–18 months
Class III/IV devices requiring a BGMP inspection typically take longer than Class I/II.
Brazil
ANVISA Registration
Brazil's medical device registration system, requiring a local Brazilian Registration Holder.
Overview
What ANVISA is and why it matters
Brazil's health regulator, ANVISA (Agência Nacional de Vigilância Sanitária), classifies devices under RDC 751/2022 into four risk classes. Class III and IV devices require Brazilian Good Manufacturing Practices (BGMP) certification in addition to product registration, and every device requires a Brazilian Registration Holder acting as the local legal representative.
Requirements
What you'll need
The documentation and evidence a complete submission is normally built from.
- Brazilian Registration Holder (local legal representative) appointed
- Device classification per RDC 751/2022
- Brazilian Good Manufacturing Practices (BGMP) certificate for Class III/IV
- Technical dossier submitted via ANVISA's Solicita platform
- Periodic registration renewal
Planning ranges
Typical timeline and estimated cost
Ranges illustrate general market patterns for this pathway — they are not a quote for a specific product.
Estimated cost
$10k–$80k
BGMP inspection travel/logistics for Class III/IV devices is a meaningful share of total cost.
Timelines and costs above are typical ranges illustrating general market patterns, not a quote or regulatory conclusion for your specific product. Actual figures depend on device classification, target country, and applicant readiness — professional review is required before relying on this for a business decision.
Where this applies
Applicable countries
Jurisdictions that recognise this certification. Scope and conditions still vary by product classification.
Brazil
Related
Regulatory Pathways
FAQ
Frequently asked questions
Can a foreign company register a device in Brazil directly?
No — a Brazilian Registration Holder, a locally established legal entity, must hold the registration and act as the regulatory point of contact with ANVISA.
Related
Related Certifications
Reviewed packages
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Market Entry Sprint from $2,500 · Strategy Session $500 · Pathway Brief $1,800. Professional review required before business use. No patient data on public forms.
Reviewed launch planning
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ANVISA pathway briefs start at $1,800. Or book a $2,500 Market Entry Sprint that includes regulatory pathway outline, evidence flags, and a review call.
Professional review is required before business use.