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Document and Record Controls

Document control under MO 169​

All documents required by the QMS must be controlled. MO 169 document control requirements include:

  • Documents must be reviewed and approved for adequacy before use
  • Current versions must be available at points of use
  • Changes must be identified and reviewed/approved
  • Obsolete documents must be prevented from unintended use
  • Documents of external origin (standards, regulations) must be identified and their distribution controlled

Record control​

Quality records must be maintained to provide evidence of conformity and effective QMS operation. Requirements:

  • Records must be legible, identifiable, and retrievable
  • Retention periods must be defined — MO 169 specifies minimum retention periods (typically the expected service life of the device plus at least 2 years; for implantables, typically 15 years minimum)
  • Records must be protected from deterioration, damage, and loss

Japan-specific document control requirements​

Under MO 169, the approved labelling (including approved intended use from the Shonin/Ninsho) must be controlled as a quality document. Changes to the approved labelling must flow through the change control process, and if the change requires MHLW approval (Ichibu Henko), the document control system must prevent implementation until MHLW approval is received.

Electronic records​

MO 169 accepts electronic records subject to controls ensuring integrity, security, and retrievability. Electronic records systems must prevent unauthorised modification of approved records.

Record retention requirements vary by device type: for permanent implants, retain records for at least 15 years after market release; for non-implantable devices, retain for the expected device service life plus at least 2 years; for in vitro diagnostic devices, retain for at least 2 years after the device expires or is recalled. In all cases, records related to adverse events or recalls must be retained for longer periods.