Points to Consider for Reprocessed Single-use Medical Devices in Japan

Introduction

Japan has established a regulatory framework to enable the reprocessing of single-use medical devices (R-SUDs), which historically were prohibited from reuse without formal authorization. The Ministry of Health, Labour and Welfare (MHLW) issued guidance titled Points to Consider for Reprocessed Single-use Medical Devices to support marketing authorization holders (MAHs) and other stakeholders in complying with new requirements effective since July 2017. :contentReference[oaicite:0]{index=0}

This guidance was issued in conjunction with amendments to the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, and Standards for Reprocessed Single-use Medical Devices. :contentReference[oaicite:1]{index=1}

Key Points Covered

1. Definitions

The guidance defines terms such as:

• Single-use medical devices (SUDs) – devices intended to be used once.
• Reprocessing – inspection, disassembly, cleaning, sterilization and other processing necessary before redistribution.
• R-SUDs – reprocessed single-use medical devices that meet regulatory requirements. :contentReference[oaicite:2]{index=2}

2. Application for Approval

MAHs planning to submit R-SUD applications should:

• Use the PMDA’s Consultation for assessment of R-SUDs (QMS conformity assessment) before submission.
• Undergo on-site inspections to ensure quality and safety of manufacturing processes.
• Use a generic name that clearly indicates the product is reprocessed (e.g., “reprocessed + original generic name”).
• Include branding that distinguishes the reprocessed device from the original device. :contentReference[oaicite:3]{index=3}

3. Cleaning and Sterilization

The notification requires that R-SUDs undergo validated cleaning and sterilization processes, with methods supported by existing standards and scientific evidence. Applicants must provide concepts and test data demonstrating that reprocessing achieves removal of contaminants while preserving device performance. :contentReference[oaicite:4]{index=4}

4. Labeling and Traceability

R-SUDs must:

• Clearly indicate a serial number or code to ensure traceability throughout the lifecycle.
• Display the word “reprocessed” on the device body or via an attached durable tag if direct marking is impractical.
• Include the original device’s name, approval number, and MAH information in package inserts. :contentReference[oaicite:5]{index=5}

5. Post-marketing Safety Measures

R-SUDs are subject to post-marketing obligations similar to new medical devices. For example:

• Recalls of original devices generally require recall of corresponding R-SUDs.
• MAHs must communicate safety control measures with original device holders.
• Detailed records of collection, reprocessing, and distribution must be maintained. :contentReference[oaicite:6]{index=6}

Q&A

Q: Why did Japan introduce a system for R-SUDs?
A: To provide a regulated pathway for reprocessing single-use devices with ensured safety and quality, especially where reuse may reduce waste and cost but requires robust control. :contentReference[oaicite:7]{index=7}

Q: Are R-SUDs automatically approved if they meet cleaning standards?
A: No. R-SUDs must undergo formal approval with appropriate documentation, validation, and PMDA consultation. :contentReference[oaicite:8]{index=8}

Q: Must R-SUDs use unique serial numbers?
A: Yes. To ensure traceability and safety oversight, serial numbers or equivalent codes are required on the product. :contentReference[oaicite:9]{index=9}

Conclusion

The Points to Consider guidance provides a comprehensive regulatory framework for R-SUDs in Japan, emphasizing safety, traceability, and quality assurance through validated processes and clear labeling requirements. :contentReference[oaicite:10]{index=10}