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.

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.

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.

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.

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.

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.

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.

Q: Are replacement components treated differently?
A: Yes. Replacement components must be described with specifications and their own reprocessing cycle information.

Conclusion

This guidance ensures that applications for R-SUDs are complete, scientifically justified, and demonstrate that remanufactured products meet standards equivalent to original devices.