Daiken Medical Co., Ltd.
Status of MDR Application Approval for the European Expansion of Quadec Amy PCA (Progress of Disclosure Items)
Report on MDR certification status for the European rollout of QuDEC Aimé PCA, upcoming schedule, and regulatory filings outside Europe. Although the timing of MDR certification is undecided, we plan to file within this fiscal year. The impact on this fiscal year's results is expected to be minor.
Key Figures
- Clinical evaluation responses including PMCF plan formulation
- European MDR certification timing is undecided
- MDR filing planned within this fiscal year
AI要約
Current status of performance and regulatory compliance
Report on the status of European MDR certification review for the European rollout of QuDEC Aimé PCA. Review of technical documentation, biological safety, and aseptic assurance is complete; clinical evaluation remains the main outstanding item. Working with external institutions to progress responses including a PMCF plan. Certification timing is uncertain and depends on the review process, but filing is planned within this fiscal year.
Initiatives in regions outside Europe
Beyond Europe, regulatory filings for Vietnam in Asia and regulatory filing preparation in South America are advancing. We will respond appropriately to regional regulatory requirements and proceed with overseas expansion in a phased manner.
Daiken Iki Co., Ltd.
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