Medical Device Approval Process: Overview and Practical Guide

Introduction

Japan boasts one of the world's largest medical device markets. While rankings vary among research institutions, it consistently ranks as the second or third largest globally, making it the largest market after the United States. With an aging population, the demand for medical devices is expected to increase further.

At the same time, Japan's unique regulatory framework can pose a barrier to entry for overseas manufacturers. This article provides an overview of the medical device approval process in Japan.

Fundamentals of Japanese Medical Device Regulations

Medical devices in Japan are regulated under the "Pharmaceuticals and Medical Devices Act (PMD Act)". The two main regulatory authorities are:

• PMDA (Pharmaceuticals and Medical Devices Agency)
• MHLW (Ministry of Health, Labour and Welfare)

Device Classification and Risk Levels

Medical devices are classified into four classes based on their risk level. Importantly, the approval or certification pathway depends not only on the "device classification" but also on whether "certification standards exist".

Overview of Approval Pathways

There are broadly three patterns for approval pathways:

① Notification (Class I)

General medical devices (Class I) do not require approval or certification review. Manufacturing and sales are possible with only a notification to the PMDA.

② Third-Party Certification (Class II with established certification standards)

By obtaining certification from a "Registered Certification Body" designated by the Ministry of Health, Labour and Welfare, manufacturers can sell their products without undergoing PMDA approval review. This applies to Class II regulated medical devices for which certification standards have been established.

③ Approval by the Minister of Health, Labour and Welfare (Class II-IV)

The following medical devices require PMDA review and approval by the Minister of Health, Labour and Welfare:

• Class II regulated medical devices without certification standards
• All Class III highly regulated medical devices
• All Class IV highly regulated medical devices

※Note: Class IV devices have the highest risk, and consequently require longer review periods and more detailed documentation.

Requirements for Foreign Manufacturers: Entering the Japanese Market

Overseas manufacturers wishing to sell medical devices in Japan must meet the following requirements:

1. Register as a Foreign Manufacturer
2. Conclude a contract with a domestic Marketing Authorization Holder (MAH) or establish a Designated Marketing Authorization Holder (DMAH)

The MAH (or DMAH) bears legal responsibility for product quality and safety management, as well as reporting post-market adverse events and malfunctions. Foreign manufacturers who do not possess MAH capabilities in-house typically entrust this role to a Japanese domestic partner company.

Conclusion

While Japan's pharmaceutical regulations may seem complex at first glance, accurately understanding the classification of medical devices and the presence or absence of certification standards allows manufacturers to select the optimal approval/certification route.

With the support of qualified experts, the approval process can be advanced efficiently. MK Consulting provides comprehensive support to companies aiming to enter the Japanese market. Please feel free to contact us for consultation.