| Regulatory Authority | The Brazilian Health Regulatory Agency (ANVISA) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, II, III, IV |
| Medical Device Regulations | Medical Device Regulation | Click Here |
| IVD Classification | I, II, III, IV |
| In Vitro Diagnostics Regulations | Rules on medical devices for in vitro diagnosis | Click Here |
| Device Classification Guidelines |
Refer to Attachment I or Annex 1: Medical Device Risk Classification Rules | Click Here |
| Registration Process | Product Registration | Click Here |
| Registration Timeline | Class 1 and II: 1 monthClass III and IV: 8 to 14 months |
| Requirement of Authorized Representative | YES |
| Language Requirement | Registration of a Medical EquipmentRegistration of a Medical Equipment InfographicLabels must be in Portuguese |
| Clinical Trials Information |
Clinical Evaluation of Medical Device | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | Registration is valid for 10 years, throughout the national territory. |