Cadastro — Class II Devices
The Cadastro pathway applies to Class II devices. Requires abbreviated technical documentation and ANVISA simplified review (3–6 months).
Required documentation
| Document | Notes |
|---|---|
| Device description and intended use | Including photographs and diagrams |
| Classification justification | Catalogue reference or rules analysis |
| Essential requirements checklist | Against RDC 751/2022 Annex II |
| Risk management summary | ISO 14971 approach |
| Labelling and IFU (Portuguese) | Compliant with RDC 754/2022 |
| CBPF GMP certificate | From manufacturer |
| FSC (Free Sale Certificate) | Required for imported devices |
Cadastro registration is valid for 10 years from the date of approval. Material post-registration changes (design, manufacturing site, intended use expansion) require submission of a Petição de Alteração; minor labeling or contact information changes may be reported via simplified procedures.
Verify all information against official ANVISA sources before making regulatory decisions.
For Class II devices via Cadastro, a clinical summary or evidence of substantial equivalence is required. This may take the form of: (a) a 3–10 page literature review (systematic search of PubMed, regulatory submissions) summarizing safety/performance; (b) substantial equivalence demonstration comparing technical, clinical, and biological dimensions to a marketed predicate; or (c) manufacturer technical file extract if the device is a line extension of an already-registered device. This may include peer-reviewed publications, regulatory submissions, or manufacturer technical files demonstrating safety and performance.
The risk management summary should include: hazard identification, risk analysis (probability and severity matrices), risk control measures implemented, residual risk assessment, and verification/validation data supporting risk control effectiveness. For Class II devices, a summary of ISO 14971 compliance (typically 5–15 pages) is acceptable; full formal risk management file is not required for Cadastro but must be maintained by manufacturer for inspection.
For Class II devices via Cadastro, a literature-based clinical summary or evidence of substantial equivalence to a comparator device is required. This may include peer-reviewed publications, regulatory submissions, or manufacturer technical files demonstrating safety and performance.