About AMDD

Greetings from the Chairman

Kosuke Kato Chairman, AMDD

AMDD was established as an independent body in 2009 to continue the industry activities previously undertaken by the Medical Devices and Diagnostics Subcommittee of the American Chamber of Commerce in Japan (ACCJ). Since then, we have been engaging in activities that seek to provide patients, medical practitioners, and others in Japan with advanced medical technologies that comply with international standards. Specifically, this has included working with various other organizations on overcoming the issue of “device lag”, and encouraging the establishment of a regulatory framework that is appropriate to medical devices. Along with shortening the time taken for the approval of medical devices, we are also delighted that this has led to the introduction of the Pharmaceuticals and Medical Device Act, something that we had pursued for a long time, which was passed in November 2013 and took effect from November 2014. This is an opportunity for a major leap forward by the medical device industry in Japan.

AMDD will celebrate its seventh anniversary in 2016. This year will be a milestone for us, marking a new stage in our career as we become an “ippan shadan hojin” (general incorporated association), enabling us to make an even greater contribution to Japanese healthcare. We have chosen to take this step in the belief that restructuring in this way will improve transparency and confidence in us as an organization, while enabling us to make an even greater contribution to medicine and healthcare in Japan.

As part of the incorporation, we have decided on a new mission statement for AMDD; “Providing valuable medical technology and information to your loved ones today, so that they may live in good health.” Medical devices and in-vitro diagnostics (IVD) are utilized in a wide variety of ways that extend beyond the treatment of illness, such as prevention and achieving a better post-treatment prognosis. As an industry body that provides such medical devices and IVDs to patients in Japan, we are dedicated to our new mission and in further expanding the scope of our activities.

As an organization with deep roots in Japan, we have set the following as our main priorities.

1. Implement an appropriate evaluation for innovation
To enable the provision of valuable medical technology and information to patients within constrained healthcare budgets, we will lobby for the establishment of a better regulatory environment.

2. Support appropriate execution of PMD Act and rapid application review
With the medical device industry acknowledged as playing a role in national strategy, we will engage in dialogue with the government to ensure that the PMD Act is administered appropriately so that Japanese products can actively participate in international markets. We will also work with the government on ways to further speed up the approval process.

3. Contribute to develop the Japanese medical device industry
As an association made up primarily of the Japanese subsidiaries of companies headquartered mainly in the USA, we will strive to achieve further advances in Japanese medical device industry.

AMDD intends to continue making a contribution to the development of Japanese healthcare through its activities in collaboration with the Japanese administration, medical societies, and related industry associations, while also maintaining close relationships with the with the U.S. Government and the U.S.-based Advanced Medical Technology Association (AdvaMed). We look forward to your ongoing recommendations and support for the AMDD.

January 2016

Chairman, American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)
Kosuke Kato
Managing Director, Edwards Lifesciences Limited