Guidance Documents — By Device Type
ANVISA publishes guidance specific to device types and technology categories. This page indexes key guidance by device type.
Medical devices
| Device type | Guidance available |
|---|---|
| Active implantable devices (pacemakers, defibrillators) | Nota Técnica on clinical evidence requirements |
| Orthopaedic implants | Classification catalogue entries; biocompatibility guidance |
| Diagnostic imaging equipment | RDC 56/2001; CNEN radiation requirements |
| Dialysis equipment | Specific essential requirements; water quality standards |
| Surgical instruments | Classification catalogue; sterilisation guidance |
| Wound management | Classification catalogue entries |
| Software / SaMD | ANVISA digital health framework guidance |
IVDs
| IVD type | Guidance available |
|---|---|
| Infectious disease IVDs (HIV, Hepatitis) | ANVISA Nota Técnica on performance requirements |
| Blood banking IVDs | Class IV requirements; reference laboratory data |
| Self-test IVDs | Usability testing requirements; lay-user labelling |
| Molecular diagnostics (PCR, NAT) | Performance evaluation guidance |
| Point-of-care IVDs | ANVISA Q&A; performance under lay-use conditions |
Finding device-specific guidance
Search the ANVISA portal by device type name in Portuguese. ANVISA's technical teams also respond to consultas de enquadramento (classification inquiries) and pre-submission consultations for novel devices.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.