Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
ANVISA
Register your medical device in Brazil.
Register your medical device with ANVISA through Notification (Classes I/II) or Registration (Classes III/IV), with a local Registration Holder and certified GMP.
Speak to a specialistThe authority
Agência Nacional de Vigilância Sanitaria
ANVISA
Since 1999
Brazil
An autonomous federal agency linked to the Ministry of Health, responsible for the sanitary control of health-related products and services in Brazil.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, simplified Notification | Gauze, bandages, non-surgical masks |
| Class II | Medium risk, Notification | Basic infusion pumps, electronic thermometers |
| Class III | High risk, Registration and GMP | External pacemakers, electrical surgical equipment |
| Class IV | Highest risk, full Registration and GMP | Cardiac implants, valves, haemodialysis equipment |
Registration process
How we manage your project
- 01
Registration Holder2-3 months
Establish a Brazilian company with AFE (Operating Authorisation)
- 02
Product classification2 weeks
Classify the product in accordance with RDC 751/2022
- 03
GMP (Classes III and IV)6-12 months
Obtain a Good Manufacturing Practices Certificate under RDC 665/2022
- 04
Technical dossier3-5 months
Prepare the application in Portuguese according to the class requirements
- 05
Submission and assessment6-12 months
Notification: immediate release. Registration: technical assessment of 6-12 months
- 06
Publication in the DOU1-2 weeks
Registration number published in Brazil's Official Gazette (Diário Oficial da União)
Total timeframeNotification: 3-6 months. Registration: 12-24 months including GMP
Local representativeRegistration Holder (Brazilian company with AFE)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | VIGIMED technovigilance and Notivisa for adverse events |
| Renewal | 10 years, renewable |
| Required QMS | ANVISA GMP RDC 665/2022 or ISO 13485 (internationally recognised) |
How HSC helps
Your company in Latin America's largest market within 12 to 24 months.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about ANVISA
Next step
Ready to start your project in Brazil?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist