| Regulatory Authority | National Authority of Medicines and Health Products (INFARMED) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Medical Devices Regulation | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Registration Process | Registration Instructions | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Portuguese Language |
| Database | SIDM | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | The Information System for Medical Devices (SIDM) is the responsibility of INFARMED, IP, as the Competent Authority responsible for monitoring the medical devices market. SIDM allows an integrated view of the medical device circuit in the national market, from the manufacturer to distributors, supporting the different market surveillance activities for medical devices. |