#Japan #Tokyo #Medical Devices #Recall Management #Legal Risks

Overview of the Seminar

This upcoming seminar, hosted by the Japan Planning Institute (JPI), features Shinichiro Nakano, a lawyer from the Mori Hamada & Matsumoto law firm, who specializes in medical device recalls. The session is scheduled for April 22, 2026, and will delve into crucial topics surrounding the practicalities of initial judgment and documentation management during medical device recalls.

Importance of Preparedness

Medical device manufacturers often face emergencies such as recalls, regulatory inspections, and potential lawsuits. While these crises can appear spontaneous, their outcomes are largely influenced by pre-existing judgment and systematic preparation. In this seminar, attendees will gain insights from a legal professional with firsthand experience in product liability litigation and unannounced inspections. The session will highlight how the documents and explanations provided during initial responses are appraised later and offer strategies for effective collaboration with overseas headquarters.

Target Audience

The seminar is specifically designed for management and operational leaders in the reliability assurance, quality assurance, and legal departments involved in crisis response. It aims to provide practical frameworks and systemic designs necessary to minimize costs and chaotic responses during incidents while safeguarding the business's interests.

Detailed Agenda

1. Understanding Crisis Responses in Medical Device Manufacturing
- The nature of unexpected emergencies and their origins in routine decisions.
- The imperative of initial design for effective crisis management.
- Addressing malfunction reports and preparedness for recalls.
- Proactive responses to regulatory guidance before inspections occur.
- The adverse effects of irreversible documentation created during initial responses.
- Effective engagement with global headquarters for seamless operations and communication.

2. Practical Aspects of Product Liability Litigation
- Evaluating malfunction reports and how they influence disputes.
- Judgments surrounding recalls and their implications.
- Critical insights into global recalls and negotiations with authorities.
- The interaction of damages and insurance relations tied to recalls.
- What is assessed in the context of product liability lawsuits?
- Collaboration with international parties post-dispute and unique features of Japanese PL lawsuits.

3. Handling Unapproved Medical Devices and Regulatory Challenges
- The regulatory framework surrounding medical device advertisements.
- The process and implications of unannounced inspections.
- Key departmental roles and internal responsibilities concerning inspections and regulatory communications.
- The importance of documentation submitted to authorities and the distinctions between facts, perceptions, and evaluations.

4. Strategies to Support Crisis Management from Routine Operations
- The correlation between routine planning and crisis-related costs.
- Essential points in practical design applicable to both normal and emergency scenarios.

5. Q&A Session
- Engage in direct dialogue with the speaker and network with attendees from diverse sectors.

Registration and Fees

Participants can choose to attend in-person or join live broadcasts. Additionally, an option for archiving the sessions post-event is available. The registration fee is set at 37,310 JPY for individual attendees, with a reduced rate for organizations registering multiple participants.

Conclusion

This seminar presents a rare opportunity for attendees to directly engage with a legal expert while expanding their professional networks. It promotes the acquisition of practical insights and the initial design of systems to better handle crises in the medical device industry.
Those interested in the seminar can find more information and sign up through the provided link.

(For full registration details, visit JPI Seminar Registration.)