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PMS Plan Requirements (RDC 751/2022)

The Post-Market Surveillance (PMS) plan (plano de tecnovigilância) is a required component of the technical dossier for Class III and IV devices and must be submitted as part of the Registro application.

The PMS plan must describe:

  • Methods for systematically gathering and reviewing post-market data;
  • Sources of data (NOTIVISA reports, complaint records, published literature, registry data);
  • Criteria for triggering corrective actions;
  • Frequency of review (at minimum annually);
  • Responsible persons for PMS activities; and
  • Link to risk management process (ISO 14971).

For Class II devices, a simplified PMS approach is acceptable for the Cadastro submission.

Official sources

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