Points to Consider for the Preparation of Applications for Marketing Approval of Remanufactured Single-use Medical Devices in Japan

Overview

Japan’s Ministry of Health, Labour and Welfare (MHLW) issued the “Points to Consider for the Preparation of Applications for Marketing Approval of Remanufactured Single-use Medical Devices” to provide detailed instructions for applicants on how to prepare marketing approval applications for remanufactured single-use medical devices (R-SUDs). This guidance forms part of the regulatory framework under the Pharmaceuticals and Medical Devices Act (PMD Act) and related Enforcement Regulations. :contentReference[oaicite:0]{index=0}

Key Application Content Requirements

Scope & Definitions

• The guidance applies to products recognized as remanufactured single-use medical devices (R-SUDs) under the Enforcement Regulations.
• Definitions include the remanufacturing process, component recycling process, and final production process which span from receipt of used devices to release of the remanufactured product. :contentReference[oaicite:1]{index=1}

Application Structure

Applicants must complete all required fields of the marketing approval form, including:

1. Category – Should match the category of the original single-use medical device (SUD).
2. Name – Generic name must begin with “reprocessed”. Brand name must include “reprocessed” and the marketing authorization holder’s name.
3. Intended Use/Indications – Must not exceed those of the original device.
4. Shape, Structure, and Principle – Detailed information on recyclable and replacement components is required.
5. Raw Materials – Describe materials of recyclable and replacement components, including maximum number of reprocessing cycles.
6. Performance and Safety Specifications – Detailed performance and safety data comparable to the original device. :contentReference[oaicite:2]{index=2}

Manufacturing & Traceability

• Include detailed reprocessing flow charts and description of each step: receipt, disassembly, cleaning, sterilization, and storage.
• Explain traceability methods that link recycled parts to finished products throughout the process. :contentReference[oaicite:3]{index=3}

Use & Shelf Life

• Intended use methods must mirror those of the original device.
• Shelf life must be supported by stability data and specify differences by number of reprocessing cycles if applicable. :contentReference[oaicite:4]{index=4}

Q&A

Q: What must be shown about the intended use of an R-SUD?
A: The intended use or indications of the remanufactured device must not exceed those of the original single-use device. :contentReference[oaicite:5]{index=5}

Q: Must traceability be included in the application?
A: Yes. Applicants must describe methods to ensure traceability from collection of used parts to distribution of remanufactured products. :contentReference[oaicite:6]{index=6}

Q: Are replacement components treated differently?
A: Yes. Replacement components must be described with specifications and their own reprocessing cycle information. :contentReference[oaicite:7]{index=7}

Conclusion

This guidance ensures that applications for R-SUDs are complete, scientifically justified, and demonstrate that remanufactured products meet standards equivalent to original devices. :contentReference[oaicite:8]{index=8}