Forms, Templates & Checklists
ANVISA provides official forms, templates and checklists for many regulatory processes. These are available via the Peticionamento Eletrônico portal and the ANVISA website.
Key forms and templates
| Document | Purpose |
|---|---|
| Essential Requirements Checklist | Template for demonstrating compliance with RDC 751/2022 Annex II |
| CBPF inspection checklist | Self-assessment against GMP requirements before an ANVISA inspection |
| Petição de Alteração form | Post-registration change petition |
| NOTIVISA report form | Adverse event and technical complaint reporting |
| AFE application form | Company operating authorisation |
| FSC (CFG) request form | Free Sale Certificate (Certificado de Exportação) |
| Technical file index template | Recommended structure for the registration dossier |
Industry-developed templates
In addition to ANVISA's official forms, industry associations (ABIMO, SBCTA) and regulatory consultancies provide templates for:
- Risk management plan (ISO 14971)
- Clinical evaluation report (CER)
- PMS plan
- CAPA form
- Supplier audit checklist
These industry templates are not official ANVISA documents but are widely used and generally accepted by ANVISA when they address all required content.
- ANVISA — Peticionamento Eletrônico
- ABIMO — Associação Brasileira da Indústria de Artigos e Equipamentos Médicos e Odontológicos
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.