Medical Device Supply Chains in Japan

In general, medical devices are supplied to medical institutions (customers) through distributors (dealers). Distributors play a crucial role in providing an extensive technical support for healthcare professionals in collaboration with medical device manufacturers.

What is the National Health Insurance (NHI)?

Japan has a universal health insurance system, which means all Japanese citizens and residents must be enrolled in and pay premiums based on income and number of people in the household for some form of public health insurance. Public health insurance schemes are designated according to employment status, age, and residence.

One type of public health insurance is the National Health Insurance (hereinafter referred to as NHI). NHI covers everyone not insured by employer-based health insurance or health insurance for people aged 75 and over. When visiting a hospital or clinic, Enrollees show their health insurance card at reception, they pay only their share at the counter, and NHI pays the rest directly to the provider.

What are the Registered Certification Bodies (RCBs) ?

For devices that require “Certification by a registered certification body”, the product must be certified by a registered certification body (RCB).

RCBs are third-party entities accredited by the MHLW to review and certify medical devices. They play a significant role in: 

●Product review

Evaluating the device against Japanese Industrial Standards (hereinafter referred to as JIS). 

JIS are the standards used for industrial activities in Japan, coordinated by the Japanese Industrial Standards Committee (JISC) and published by the Japanese Standards Association (JSA).

●QMS audit

Conducting a Quality Management System (QMS) audit of the manufacture's facilities to ensure compliance with MHLW Ministerial Ordinance No.169 (2004) titled "the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro

Medical Device Registration pathway in Japan

There are three main routes for medical device registration in Japan.

Medical Device Classification and Regulation in Japan

Medical Devices are classified into 4 categories based on their intended use and safety risk.

Pre-market regulatory process for Medical Devices differs depending on the classification.

Overview of the medical device industry in Japan

Japan’s market for medical devices continues to be among the world’s largest. The global market for the medical device industry was worth approximately $517.6 billion in 2023, with the United States accounting for approximately 47% and Japan accounting for approximately 5%. It is projected to grow to approximately $654.3 billion by 2027 with an expected expansion at a compound annual growth rate (CAGR) of 5.9% in the 2018–2027 period. The Japanese medical device market is growing at a CAGR of 3.7%, and although this growth is not as large as in other regions, it is expected to be a market of approximately $38 billion by 2027. Japan’s medical device market depends heavily on imports, especially therapeutic medical devices. This trend is likely to continue in the future.

In order to market medical devices in Japan, a foreign manufacturer has to obtain approval/certification or submit notification, depending on the classification, pursuant to PMD Act, through a Japanese Marketing Authorization Holder (MAH) or a Japanese manufacturer appointed by such foreign manufacturer.