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
- 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
Typical timeline
6–18 months
Class III/IV devices requiring a BGMP inspection typically take longer than Class I/II.
Estimated cost
$10k–$80k
BGMP inspection travel/logistics for Class III/IV devices is a meaningful share of total cost.
Where this applies
Applicable countries
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 launch planning
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