Global Regulatory Pulse

Guidelines for Medical Device Development in Japan

In Asian Market, Regulatory by Chikako Kitayama

Japan is a country leading the way in high-tech, high-quality medical devices. As medical products are rapidly evolving, so too is the idea that new and innovative products can change the world while also bringing Japan significant economic growth.

In recent years, the Japanese government has developed policies to help strengthen R&D of the country’s medical device industry. This includes recent work by the Ministry of Health, Labor and Welfare (MHLW) to develop guidelines to help facilitate the development of innovative medical devices and regenerative products in parallel with other organizations.

Recently, the MHLW collaborated with the Ministry of Economy, Trade and Industry (METI). While METI is responsible for establishing guidelines for the R&D process, MHLW is responsible for providing indexes used for the review process of the same medical devices (providing continuous support from R&D to marketing). The result of this collaboration are the guidelines entitled, “Guidelines for Medical Device Development” for R&D and “Next Generation Medical Device Evaluation Index” for review, respectively.

The “Guidelines for Medical Device Development,” established by METI, provide guidelines for technical items related to engineering properties or biological safety that should be evaluated before approval submission, during the R&D process. The guidelines demonstrate detailed methods, conditions and/or acceptance criteria for evaluation tests to help identify experimental conditions. In addition the “Next Generation Medical Device Evaluation Index” provides a total of 28 indexes, which was recently published by the MHLW, available here.

The combination of the “Guideline for Medical Device Development” and “Next Generation Medical Device Evaluation Index” has helped propel Japanese medical device development. It has also provided rapid approval for various Implantable Ventricular Assist Systems.  Using a combination of METI/MHLW guidelines and indexes, EVAHEART from Sun Medical Technology Corp., DuraHeart from Terumo, HeartMate II from Thoractec/Nipro, and Jarvic2000 from JarvicHeart/CMI were approved, all with relatively shorter approval timelines although they are considered high-risk medical devices.

MHLW is also conducting a regulatory project connecting academia to PMDA or National Institute of Health Sciences (NIHS), named “Promotion of practical application of innovative pharmaceuticals, medical devices and regenerative products.” This is a project to encourage academia to establish a new evaluation method for innovative pharmaceuticals, medical device and regenerative products related to regulatory science through personal exchange. Success to date includes two MHLW notifications, announced on November 22, 2016 for the “Method for in vitro thrombogenicity testing for continuous hemofilter,” and “Guideline for development of regenerative cell product to treat cerebral infarct.”

As demonstrated above, the MHLW is making significant efforts to accelerate medical device development through government policy. Japan will only continue to see a rise in new concept devices based on the wide range of guidelines available for use during the product approval process, making the Japanese marketplace an attractive geography for device development.

For more information on METI/MHLW guidelines, 31 in total, please click here.

We also encourage you to speak with our Japanese medical device experts regarding the benefits of product development in Japan. Please reach out to us at


Chikako Kitayama currently serves as Medical Research Manager for NAMSA-Japan.