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Complaint Handling and Adverse Event Interface

Complaint handling is a key post-market QMS element (ISO 13485:2016 Section 8.2.2), directly interfacing with the MFDS adverse event reporting obligation.

Complaint handling requirements​

  • A documented procedure for receiving, recording, investigating, and resolving complaints
  • All complaints must be recorded and evaluated — even those not meeting the adverse event reporting threshold
  • Investigation to determine whether the complaint represents a reportable adverse event
  • Trend analysis of complaints to identify systemic quality issues

Interface with adverse event reporting​

Every complaint should be evaluated against MFDS adverse event reporting criteria:

  • Does it involve a serious adverse event (death, serious deterioration)? → 15-day report required
  • Does it involve a reportable malfunction (could cause death/serious injury if recurring)? → 30-day report required
  • All complaints feed into the PMS system and trend analysis

Records​

Complaint records must be retained for the lifetime of the device plus the minimum retention period specified by MFDS.

Complaint records should be retained for a minimum of 5 years from the date of receipt, or for the lifetime of the device plus additional years as specified in product-specific regulations, whichever is longer.

Complaint records must be retained for a minimum of 5 years from the date of receipt, or for the lifetime of the device plus additional years as specified in product-specific regulations, whichever is longer.