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Complaint Handling

What constitutes a complaint​

Under MO 169, a complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, or performance of a device that has been released to the market. This includes:

  • Reports of device malfunction
  • Reports of injury or near-miss
  • Reports of labelling errors
  • Reports of packaging defects
  • General expressions of dissatisfaction with device performance

Complaint handling system requirements​

The MAH's complaint handling system must:

  1. Receive and document all complaints in a complaint register
  2. Evaluate each complaint to determine whether it constitutes a potentially reportable adverse event
  3. Investigate each complaint to determine root cause
  4. Take corrective action where the investigation identifies a systemic issue
  5. Report to MHLW where the complaint meets adverse event reporting criteria
  6. Maintain records of all complaints, investigations, and actions

The complaint handling system is the primary source of adverse event reports. The evaluation step — determining whether a complaint meets reportability criteria — is a critical function. Failures in complaint handling evaluation are a common cause of late adverse event reports to MHLW.

All complaints originating from or affecting the Japanese market must be documented and evaluated by the MAH. The MAH is responsible for determining whether complaints meet adverse event reporting criteria under Japanese regulations. Where complaints first reach the overseas manufacturer, a mechanism must exist to promptly forward them to the MAH for Japan regulatory evaluation.

Complaints must be evaluated and investigated within a defined timeframe (typically within 10 business days of receipt). If a complaint meets adverse event reporting criteria, it must be reported to MHLW within the applicable reporting window (typically 30 days from the date MHLW receives the report, depending on the severity and urgency classification).