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MAH Reporting Obligations

JP-unique

Japan's system places all formal adverse event reporting obligations on the MAH. There is no mechanism for healthcare providers, patients, or foreign manufacturers to report directly to MHLW — all reports must flow through the Japan-domiciled MAH. This is a significant difference from EU MDR (where manufacturers report directly to competent authorities) and from FDA (where manufacturers, importers, and device user facilities all have independent reporting obligations).

The MAH as the reporting hub​

The MAH is the legal entity responsible for:

  1. Receiving complaints and adverse event information from all sources — healthcare institutions, distributors, the overseas manufacturer, overseas regulatory authorities, literature, and direct patient reports
  2. Investigating each report to assess the nature of the event and the role of the device
  3. Determining reportability — applying the PMD Act criteria to decide whether and when to file with MHLW
  4. Filing the report with MHLW in the prescribed format within the required timeline
  5. Conducting follow-up and filing supplementary reports as the investigation progresses
  6. Maintaining records of all complaints, reports, and investigations

Receiving information from overseas manufacturers​

Where the overseas manufacturer is not the MAH, the contract between the manufacturer and the MAH must include provisions for:

  • The manufacturer to notify the MAH promptly of adverse events involving the device anywhere in the world
  • The manufacturer to provide all relevant information to the MAH for the purpose of reporting to MHLW
  • The manufacturer to cooperate with MHLW investigations as directed by the MAH

Failure to establish these contractual provisions is a common oversight that can result in late reporting to MHLW.

Record-keeping requirements​

MAHs must maintain records of:

  • All complaints received, regardless of whether they were reportable
  • The investigation conducted for each complaint
  • The reporting decision made and its basis
  • All reports filed with MHLW and MHLW's responses
  • Corrective actions taken

Records must be retained for a minimum period specified in the relevant MHLW notification (typically 5 years or longer for certain device classes).