Handling Application for Confirming Change Plans for Medical Devices in Japan

1. Regulatory background and scope

Japan introduced an “advanced notification system” for confirmation of medical device change plans in connection with the amended PMD Act coming into effect on September 1, 2020. The notification explains how confirmation is conducted for change plans relating to key approved items (e.g., intended use/effect, shape/structure/principle, raw materials, performance/safety standards, method of use, storage, expiration, and manufacturing method).
Reference: Handling Application for Confirming Change Plans for Medical Devices (PSEHB/MDED Notification No. 0831-14, Aug 31, 2020)

2. Start with PMDA consultation (practical expectation)

To support smooth and efficient formulation of a change plan, the notification states that, for the time being, applicants should submit an application for pre-consultation for medical device development to PMDA and receive advice on whether the proposed change plan is subject to this notification.
Reference: PMDA/MHLW Notification (000275276)

3. What to write in the application form

Applications are made under the forms stipulated in the enforcement regulations (e.g., “Application for Confirmation of Medical Device Change Plan” and “Application for Change of Confirmed Items…”). The notification emphasizes that submitted materials should:

• summarize the contents accurately and concisely,
• include reasons for setting the change plan,
• include information on conformity to relevant standards (including the MHLW-designated standards framework), and
• be written in Japanese.
  Reference: PMDA/MHLW Notification (000275276)

Practical formatting: “before/after” comparison

The notification indicates that key columns should be prepared in principle as a comparison table between before and after the change (e.g., category, name, and remarks handling when an approval is concurrently under review).
Reference: PMDA/MHLW Notification (000275276)

4. Attached documents: test planning and dossier expectations

4.1 Test plans must align with GLP/GCP expectations where applicable

The notification states that test plans for preparing attached documents should comply with relevant ministerial ordinances such as:

• GLP for nonclinical safety studies of medical devices, and
• GCP for medical devices,
  and be appropriately planned using current academic standards by experienced researchers in adequately equipped facilities.
  Reference: PMDA/MHLW Notification (000275276)

4.2 Use STED-style structure and follow existing attached-document rules

Attached documents should comply with the “Approval Application Attached Document” expectations and follow the Summary Technical Document (STED) format agreed by the Global Harmonization Task Force (as referenced in the notification).
Reference: PMDA/MHLW Notification (000275276)

4.3 Examples of what may be required (Attached Table 1 / Table 2)

The notification provides tables listing typical attachments. Examples include:

• Change plan package: development background, status of use in Japan/overseas, documents related to the change plan, and an old/new comparison table.
• Design/development verification: protocols for verifying performance/safety changes, risk management implementation plans, safety measures plans, manufacturing process/site change plans, sterilization change plan, clinical study/clinical evaluation protocols, post-marketing surveillance plan, and package insert documents.
• For certain technology contexts (including where performance is expected to change after marketing), additional procedures/documents describing responsibilities, review/verification/validation processes, and confirmation of implementation are described in the tables.

5. How to compile the submission package (editing rules)

When filing, the notification describes compiling documents (in principle) such as:

• copy of the change plan confirmation application,
• copy of the latest marketing approval documentation (and making older documents available upon request), and
• attachments and protocols.
  Reference: PMDA/MHLW Notification (000275276)

6. Managing updates to the plan and implementing changes

6.1 If the change plan itself changes

When changing a confirmed change plan, applicants should determine whether to apply for confirmation of the change plan change or submit a minor change notice, based on whether the change requires evaluation of quality, efficacy, and safety for the plan/product.
Reference: PMDA/MHLW Notification (000275276)

6.2 If you implement changes “according to the change plan”

When implementing a change according to the plan, applicants must judge whether:

• notification within the scope of the plan is appropriate, or
• a partial change approval application is required,
  and PMDA consultation is expected as needed until the relevant scope notifications are made.
  Reference: PMDA/MHLW Notification (000275276)

6.3 Timing after notification

The notification states that the number of days until the change can be made after notification is 30 days (per the cited enforcement regulation article).
Reference: PMDA/MHLW Notification (000275276)

7. Key takeaways for applicants

• Engage PMDA early via pre-consultation to confirm whether the change plan fits the system.
• Build a clear “before/after” comparison narrative and ensure all materials are prepared in Japanese.
• Treat attached documents like a structured technical dossier (STED-oriented), supported by appropriately planned verification/validation evidence.
• Plan for lifecycle management: how the plan might change, and how implementation notifications and evidence will be produced and filed.