Points to Consider for Preparation of Attached Data to Application Form for Marketing Approval of Reprocessed Single-use Medical Devices in Japan

Overview

This document titled Points to Consider for Preparation of Attached Data to Application Form for Marketing Approval of Reprocessed Single-use Medical Devices provides detailed guidance about the attached data that must accompany a marketing approval application for reprocessed single-use medical devices (R-SUDs) in Japan. The guidance was issued by the Ministry of Health, Labour and Welfare (MHLW) and applies to R-SUD applications submitted under the Pharmaceuticals and Medical Devices Act (PMD Act). ([turn0search0]; [turn0view0])

The attached data included in an application is critical for proper evaluation of product quality, safety, and equivalence to the original single-use medical device (SUD).

Structure of Attached Data

1. Product Overview

Applicants should provide a clear overview of the R-SUD, including:

• Summary of product characteristics.
• Development history explaining how and why the R-SUD was developed relative to the original SUD.
  These should follow formats specified in the Medical Device Attached Data Notification referenced within this guidance. ([turn0view0])

2. Design, Verification and Validation

• Provide comprehensive design details including differences from the original SUD and rationale.
• Include design verification and validation materials (test results, protocols, dates, and outcomes) that support safety and performance.
• Explain any use of OEM devices as test specimens and reasons for alternative selections. ([turn0view0])

3. Comparative Analysis

• Clearly compare the proposed R-SUD to similar devices, including the original SUD, focusing on structure, materials, use, and performance.
• Provide data sources and justification for chosen comparators.
• Include international usage data if the R-SUD or similar products are used outside Japan. ([turn0view0])

4. Conformity with Standards

• Document compliance with Essential Requirements and standards for medical devices.
• Provide checklists and attach test certificates or analysis demonstrating conformity.
• Justify selected specifications where standards do not exist. ([turn0view0])

5. Supplementary Data

• Include any additional supporting data that enhances clarity, such as stability data, safety risk management explanations, or unique distribution details.
• If package inserts are required, provide draft inserts with rationale for warnings, contraindications, and precautions. ([turn0view0])

Q&A

Q: Why is attached data important for R-SUD applications?
A: Attached data provides the PMDA and reviewers with comprehensive proof of design, verification, performance, safety, and comparisons to the original SUD necessary to evaluate the application thoroughly. ([turn0search0]; [turn0view0])

Q: Must attached data include design validation results?
A: Yes. Verification and validation test records must be summarized and attached to support the product’s quality and safety claims. ([turn0view0])

Q: Can international use information be included?
A: Yes. Information about R-SUD use and approval in foreign regions helps contextualize global experience and demonstrate performance consistency. ([turn0view0])

Conclusion

Preparing attached data for an R-SUD marketing approval application requires clear product descriptions, detailed technical data, comparative analyses, conformity documentation, and supplementary evidence where necessary. Proper documentation helps ensure the PMDA can evaluate safety, efficacy, and equivalence effectively. ([turn0search0]; [turn0view0])