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.
The Technical File Index is mandatory and must be submitted with all Class III and IV device registrations; a template is available on the ANVISA portal.