Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
December 26, 2026
Approximately 5 minutes
Handling Application for Confirming Change Plans for Medical Devices in Japan (PMDA/MHLW)
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.
Have a Question?
Ask our experts about this topic. We'll do our best to respond to your question.
Related Articles
Approximately 5 minutes
Japan Medical Device Registration: Pathways and Requirements
The medical device registration process in Japan is overseen by the PMDA and varies significantly based on device classification (Class I to IV). Key pathways include Pre-Market Submission (PMS), Pre-Market Certification (PMC), and Pre-Market Approval (PMA).
Approximately 5 minutes
Japan Medical Device Local Labeling Requirements: Tempu Bunsho
Medical device labeling in Japan, specified by PMDA's Article 52, mandates the use of Japanese 'tempu bunsho' (package inserts/IFUs). This process involves rigorous content requirements, notification upon revision, and MAH/DMAH oversight for affixation.
Approximately 5 minutes
Japan Medical Device Post-Market Surveillance (PMS): GVP and Adverse Event Reporting
An overview of Japan's PMS requirements under the PMD Act, focusing on the MAH's GVP compliance, the mandatory reporting of adverse events (Fuguai), and the strict reporting timelines (e.g., 15 days for death or serious, unanticipated events).
Approximately 5 minutes
Japan Specialty Fulfillment for Medical Devices: Low Volume, High Value Sales
Specialty Fulfillment is a crucial service for foreign medical device manufacturers targeting low-volume, high-value sales in Japan, often utilizing an Independent License Holder to manage customs, storage, and distribution to maintain high profit margins.
Approximately 5 minutes
Regulatory Science in Japan: PMDA’s Evidence-Based Approach to Innovation and Public Health
This article explains what “regulatory science” means in Japan and how the PMDA advances it through organizational structures, expert deliberation, collaborations, and research dissemination. A practical Q&A is included for industry and academia.