Greetings from the Chairperson

Greetings from the Chairperson

Since its establishment in April 2009, AMDD has acted as an industrial organization for medical devices and in-vitro diagnostics (IVD), comprising of about 70 companies, including members mostly headquartered in the U.S. and associated companies. Our main role has been to act as a connection to the Japanese administration and other government-related bodies.

A long-standing focus for AMDD has been the “device lag” issue. Working closely with the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) and other organizations, we’ve established a regulatory framework that is in line with the characteristics of medical devices. As a result, approval times for medical devices have been reduced, resolving most of the device lag. The Pharmaceuticals and Medical Device Act, passed in November 2013 and implemented the following year, separated regulations for pharmaceuticals and medical devices and has since paved the way for a major leap forward in the Japanese medical device industry.

In order to enhance the organization’s credibility and transparency, AMDD transitioned from being a voluntary group to a registered ippan shadan hojin (general incorporated association) in 2016. To mark this change, we decided on a new mission statement: “Providing valuable medical technology and information to your loved ones today, so that they may live in good health.”

Medical devices and IVDs are used in a wide variety of ways that extend beyond treating illnesses, including preventive care and improvement of post-treatment conditions. As an industrial organization that serves to deliver such medical devices and IVDs to Japanese patients as promptly as possible, we have been further expanding the scope of our activities in line with this mission.

In order to promote innovation in medical devices and IVDs we have been pursuing a policy recommendation of “value-based healthcare” since 2017. Part of this recommendation has already been registered as a “C1 Challenge Application” and we’ve now established the “AMDD Medical Technology Policy Institute” think-tank within our organization to drive these efforts.

In 2020 and beyond, we believe the management and distribution of medical devices and IVDs will be critical as we enable their use in digital healthcare solutions. We look forward to continuing to play our role in a healthy society by reflecting the viewpoints of our respective member companies, working with external partners and leveraging our unique strengths as an industrial organization in the healthcare field.
AMDD will also continue to drive policy recommendations and other efforts to support the positive development of Japan’s healthcare system by collaborating with the Japanese administration, medical societies and associated industry associations, while also maintaining close relations with the U.S. government and the U.S.-based Advanced Medical Technology Association (AdvaMed).

To all our members and partners, we thank you for your continued contribution and support.

March 2024

Takanao Tamai
Chairperson, American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)
President, Johnson & Johnson K.K. and Johnson & Johnson K.K. Medical Company