Point-of-Care & Near-Patient IVDs
POC IVDs are classified under RDC 36/2015 based on risk and intended use. Examples include: self-test blood glucose monitors (typically Class II–III), self-test HIV tests (typically Class IV), pregnancy tests (typically Class II), and rapid antigen tests (Class III or IV depending on clinical context and confirmatory testing requirements).
Additional requirements for self-test IVDs
| Requirement | Detail |
|---|---|
| Usability testing | Performance studies with representative lay users |
| Simplified IFU | Plain Portuguese at appropriate reading level |
| Labelling | Clear warning about confirmatory testing where appropriate |
| Lay-use performance | Clinical performance demonstrated under non-laboratory conditions |
Verify all information against official ANVISA sources before making regulatory decisions.
Lay-use performance studies should demonstrate that the device achieves at least 95% sensitivity and 99% specificity, or device-specific performance targets, when used by lay persons without professional laboratory training. ANVISA may request additional studies in vulnerable populations (e.g., elderly, low literacy) depending on intended user characteristics.