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Minor Change Notification

Changes that require notification only​

Not all changes to an approved device require full Ichibu Henko (partial change approval). MHLW has defined categories of "minor changes" that only require a notification to MHLW after implementation (not approval before implementation).

Minor changes typically include:

  • Changes to packaging dimensions or materials that do not affect device sterility or performance
  • Changes to labelling text that do not affect safety-critical information (e.g. correction of typographical errors, updating MAH address)
  • Addition of a new size or configuration of an existing design, where the change is within the scope of the existing approval and the new variant has been tested
  • Minor manufacturing process changes within validated ranges

How to file a minor change notification​

Minor change notifications are filed with MHLW (via PMDA for Shonin devices) after the change has been implemented. The notification must include:

  • Description of the change
  • Justification for classifying it as a minor change (i.e. why it does not require Ichibu Henko)
  • Supporting data confirming the change does not adversely affect safety or performance
  • Updated labelling if the change involves labelling

Classification uncertainty — when to seek PMDA advice​

If there is any doubt about whether a change is "minor" or "significant," the MAH should seek PMDA's advice before implementing the change. Implementing a change that should have gone through Ichibu Henko without approval is a PMD Act violation.