Classification Rules — ANVISA Catalogue
Two-step process
Step 1 — Search the ANVISA Classification Catalogue (Instrução Normativa)
Step 2 — Apply classification rules (RDC 751/2022 Annex I)
| Factor | Options |
|---|---|
| Duration of contact | Transient (< 60 min) / Short-term (< 30 days) / Long-term ( > 30 days) |
| Invasiveness | Non-invasive / Invasive / Surgically invasive / Implantable |
| Active vs passive | Does the device require energy to function? |
| Critical anatomy | Contact with central circulation, CNS → higher class |
| Sterility | Devices supplied sterile → minimum Class II |
| Drug/biologic component | Typically Class IV |
Worked example
Device: Single-use, sterile, non-powered surgical suture needle.
- Transient contact, surgically invasive, non-active, supplied sterile, no CNS/cardiac contact.
- Result: Class II → Cadastro pathway.
When to request a consulta de enquadramento
Submit via ANVISA's Peticionamento Eletrônico when the device is novel, not in the catalogue, or rules produce an ambiguous result.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.