Auto-declaração (Self-Declaration) for Lower-Risk Devices

BR-unique

For some lower-risk device categories (primarily Class I and some Class II), ANVISA permits auto-declaração (self-declaration) of GMP compliance — similar in concept to the EU MDR's Class I self-declaration — rather than requiring a full CBPF inspection before the product registration is granted.

Under auto-declaração, the manufacturer or importer:

• Declares in the Registro/Cadastro/Notificação submission that the manufacturer complies with the GMP requirements of RDC 752/2022 (or equivalent international standard);
• Provides evidence of GMP compliance (e.g., ISO 13485 certificate, internal audit reports); and
• Accepts that ANVISA may conduct a verification inspection at any time.

ANVISA's post-market surveillance programme includes random inspections of companies that have used auto-declaração to verify that the declaration was accurate.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.