Point-of-Care & Near-Patient IVDs
POC IVDs classified under RDC 36/2015: self-test blood glucose monitors (Class II–III), self-test HIV tests (Class IV), pregnancy tests (Class II), rapid antigen tests (Class III or IV depending on use).
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 |
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.