Japan Change to Products Control

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Overview of Device Changes in Japan

In Japan, the Pharmaceutical and Medical Device Act (PMD Act) regulates the quality, efficacy, and safety of medical devices. When manufacturers make design changes to anexisting device, they must follow specific regulatory procedures to maintain market authorization. Unlike some other markets, the Japanese regulator (PMDA) requires notification even for minor changes.

Four Main Actions for Design Changes

Depending on the nature of the change, manufacturers must take one of four actions:

No regulatory procedure: Only internal compliance with quality management regulations (MHLW Ordinance No. 169) is required.

Minor Change Notification (Keibihenko Todoke): Required for minor

Partial Amendment Application (Ichibu Henkoh Shinsei): Required for more significant changes that do not warrant a entirely new submission.

New Submission: Required for major changes that fundamentally alter the device.

Decision Framework

To determine the correct procedure, the PMDA provides a Decision Tree and three supporting charts:

Chart A:

Focuses on changes to labeling, trade names, and intended use.

Chart B:

Focuses on engineering changes, such as shape, structure, performance, and sterilization methods.

Chart C:

Focuses on changes to the materials used in the device.

Examples of Device Changes and Required Procedures:

Category	Type of Change	Required Procedure
Administrative / Minor	Change of trade name due to merger, acquisition, or trademark interference	Minor Change Notification
Size / Variations	Adding size variations (e.g., endoscope shaft diameter) within the existing approved scope	Minor Change Notification
Manufacturing Sites	Changing the name or address of a site, or deleting a sterilization site	Minor Change Notification
Packaging & Materials	Changing packaging materials (if validated) or raw materials with equal/lower biological risk	Minor Change Notification
Major Design	Changes to the mechanism of operation or those requiring new clinical evaluation	Partial Amendment or New Application
Safety & Efficacy	Modifications affecting the intended use, performance, or fundamental safety of the device	Partial Amendment Application
Stability	Changes to the approved valid period of stability	Minor Change or Partial Amendment Application
Non-Device Changes	Changing serial/catalogue numbers, packaging units (e.g., 5-pack to 10-pack), or colors of external housing	No Procedure Required
Software/Data	Software updates within the approved scope that do not affect performance	No Procedure Required

Key Deadlines and Requirements

Minor Change Notification: Must be submitted within 30 days of the change occurring.

Partial Amendment Application: Must be approved before the changed device can be released to the Japanese market.

Risks of Non-compliance

Failure to follow these procedures, especially common among foreign manufacturers who may overlook minor changes, carries significant risks:

Market Recall: If a changed device is released without the proper notification or approval, the registrant must recall those devices from the market.

Audit Findings: Under the Medical Device Single Audit Program (MDSAP), auditors verify that manufacturers have obtained the necessary Japanese marketing authorizations for all changes.

Conclusion

While Japan's regulations are strict, the PMDA and MHLW provide detailed guidance to help manufacturers navigate the process. For complex changes, it is highly recommended to consult with the PMDA or a Registered Certification Body (RCB) beforehand.