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MAH Responsibilities and Liability

Full list of MAH obligations under the PMD Act​

The MAH's statutory obligations under the PMD Act and associated ordinances include:

Pre-market:

  • Applying for and obtaining Shonin/Ninsho/Todokede
  • Filing FMR for manufacturing sites
  • Ensuring the application dossier accurately represents the device

Quality management:

  • Maintaining a QMS meeting MO 169 requirements
  • Overseeing the quality management of contracted manufacturers
  • Conducting periodic audits of manufacturing sites

Post-market surveillance:

  • Operating a GPSP-compliant surveillance programme
  • Conducting use-results surveys during re-examination periods
  • Submitting periodic safety reports to MHLW
  • Submitting re-examination applications before the end of the re-examination period

Adverse event reporting:

  • Receiving and evaluating all complaint and adverse event information
  • Filing adverse event reports to MHLW within 15 or 30 days
  • Maintaining complaint records

Field safety:

  • Making recall decisions and notifying MHLW
  • Executing and documenting recall actions
  • Issuing Field Safety Notices to affected customers

Labelling:

  • Ensuring labels comply with PMD Act requirements
  • Controlling labelling changes

Change management:

  • Filing Ichibu Henko before implementing significant changes
  • Filing minor change notifications after implementing minor changes

Personal liability of the MAH's responsible officers​

The Responsible Technical Officer (RTO) of the MAH carries personal liability under the PMD Act for compliance failures within their area of responsibility. Criminal penalties under the PMD Act can extend to individuals, not just corporate entities. This is a serious personal liability consideration for individuals accepting RTO roles at Kannin MAH companies.