Conditional Approval System for Medical Devices in Japan

Introduction

Japan has implemented a Conditional Approval System for medical devices to enable early patient access to highly innovative and necessary products while maintaining safety and effectiveness considerations. This system was clarified under the Pharmaceuticals and Medical Devices Act (PMD Act) and related notifications by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). :contentReference[oaicite:0]{index=0}

The system is part of Japan’s broader regulatory efforts to balance timely access with appropriate risk management, particularly for devices where clinical evidence at the time of conventional approval may be limited but the potential benefit for patients with serious conditions is high.

Key Features

1. Legal Basis

The conditional approval mechanism was established as part of the legal framework in Japan under the PMD Act and associated notifications. :contentReference[oaicite:1]{index=1}

2. Objectives

The main objectives of the conditional approval system are:

• To accelerate access to innovative medical devices that address unmet medical needs.
• To allow early market entry where traditional evidence requirements are difficult to meet initially.
• To ensure postmarketing data collection and continued evaluation of safety and effectiveness.

3. Process Overview

Under the system:

1. A device may be approved early with certain conditions attached.
2. These conditions typically include requirements for postmarket surveillance, risk management plans, and performance data collection. :contentReference[oaicite:2]{index=2}
3. Postmarketing studies are used to confirm clinical performance once the device is being used more broadly.

4. Risk Management and Postmarketing Requirements

Applicants must include a plan for use-results evaluation and risk management as part of the application for conditional approval. :contentReference[oaicite:3]{index=3}

Q&A

Q: What types of medical devices are eligible for conditional approval?
A: Devices that demonstrate potential significant benefit, particularly where traditional clinical evidence is challenging to obtain early, may be considered for conditional approval. The PMDA evaluates eligibility based on unmet medical needs and predicted benefit versus risk.

Q: Does conditional approval mean the device is fully approved?
A: No. Conditional approval allows early access with specific requirements. Full approval depends on subsequent data and evaluations collected during postmarketing.

Q: How does Japan’s system differ from standard approval?
A: Standard approval requires comprehensive clinical evidence before market entry. The conditional approval system allows earlier access with planned postmarketing evaluation to confirm safety and effectiveness.

Benefits and Challenges

Benefits

• Faster patient access to innovative technologies.
• Encourages development of devices for rare or severe conditions.

Challenges

• Requires robust postmarketing data collection and active risk management.
• Early clinical evidence might be limited, requiring careful follow-up.

Examples & Implementation

The Conditional Approval System has been part of PMDA’s regulatory toolbox since around 2017, with continuing refinement through notifications and law amendments, to better clarify how conditions should be applied and managed. :contentReference[oaicite:4]{index=4}

Conclusion

Japan’s Conditional Approval System for medical devices represents a significant regulatory pathway that supports the early availability of high-impact innovations while ensuring continued monitoring and evaluation to protect patient safety.