Notification or registration with ANVISA through a Brazilian Registration Holder.
Classification, notification or registration, Brazilian GMP certification, and INMETRO certification where it applies.
Key facts
Pathways
- Class I and II: notification (notificação)
- Class III and IV: registration (registro)
- INMETRO certification for certain electromedical devices
- Brazilian GMP certification by ANVISA for Class III and IV manufacturers
What you will need
- Technical dossier per ANVISA requirements
- Labelling and IFU in Portuguese
- Brazilian GMP certificate (Class III and IV)
- INMETRO certificate where required
Sequence and decision points
- 01ClassifyApply RDC 751/2022 or RDC 830/2023 rules.
- 02Appoint a BRHA local holder with ANVISA company authorisation.
- 03CertifyBrazilian GMP and INMETRO where required.
- 04SubmitNotification or registration dossier.
- 05Market and monitorTechnovigilance and renewals.
Brazilian GMP (RDC 665/2022). ANVISA certification is required for Class III and IV and can draw on MDSAP audit reports.
A Brazilian Registration Holder, a local company with ANVISA authorisation, must hold the notification or registration.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
ANVISA fees depend on class and company size. GMP certification and INMETRO can be the longest lead items.
After market entry
- Technovigilance reporting to ANVISA
- Field actions and recalls
- Registration renewal for Class III and IV
- Change notifications
How we help
- Classification and pathway strategy
- Brazilian GMP readiness and MDSAP alignment
- Dossier preparation support
- BRH coordination
- Technovigilance support
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about Brazil
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Can MDSAP help with Brazilian GMP?
Yes. ANVISA participates in MDSAP and can use MDSAP audit reports in its GMP certification process.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.