Annual PMS Report

Registration holders must produce an annual PMS report (relatório periódico de tecnovigilância) for Class III and IV devices, documenting:

• Summary of all adverse events and technical complaints in the period;
• Results of investigations and corrective actions;
• Post-market clinical follow-up data (if applicable);
• Updated risk-benefit assessment;
• Any proposed changes to the technical dossier or PMS plan; and
• Conclusions on the continued safety and performance of the device.

The PMS report must be retained by the registration holder and made available to ANVISA on request.

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Official sources

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