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Draft RDCs Open for Public Consultation

ANVISA regularly publishes draft regulations (Consultas Públicas) for industry and public comment before finalising new RDCs.

How to find open consultations​

Monitor the ANVISA Consultas Públicas portal for currently open consultations:

Open consultations relevant to medical devices are typically listed under the "Produtos para Saúde" category.

How to participate in a consultation​

  1. Download the draft regulation and consultation document from the ANVISA portal.
  2. Review the draft and prepare written comments addressing specific articles.
  3. Submit comments via the ANVISA portal within the consultation period (typically 30–60 days).
  4. For audiências públicas: register to attend or present oral comments.

ANVISA publishes a summary of received comments and its responses after each consultation — this is publicly available and provides valuable insight into ANVISA's regulatory thinking.

Monitoring consultations​

Consider subscribing to ANVISA's notification service or monitoring ABIMO and other industry association bulletins for alerts about new consultations relevant to medical devices.

Official sources

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