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PRESS RELEASE

2014-09-09 updated

【News】Proposal for National Strategic Zone

 The Japanese Government invited proposals for taking steps to the development of National Strategic Zone pursuant to National Strategic Zone Act and Basic Policy for National Strategic Zone. CYBERDYNE Inc. (hereinafter the Company) jointly with Ibaraki Prefecture and Tsukuba City submitted the proposal to the Cabinet Office as below.

It is told that the Cabinet Office, after receiving proposals, will make a shortlist and carry out hearings.

 《Proposal for national strategic zone

 1. Name of proposal:
Strategic Zone for Robotic Innovation (Creation of New Industry Utilizing Robots)

 2. Proposers:
Ibaraki Prefecture, Tsukuba City, University of Tsukuba, the Company and Tsukuba Global Innovation Promotion Agency

 3. Site of project:
Tsukuba City and other places in Ibaraki Prefecture

 4. Outline of project:
• In the strategic zone, strict medical and welfare regulations on clinical and other tests and certification for medical and welfare devices should be relaxed so that developed innovative robotic medical/ welfare devices can rapidly be adopted to the society.

• A base focused on robot R&D, clinical tests, certification, training, and venture company incubation will be constructed, where the existing concentration of related technologies in Tsukuba City can be leveraged. The core of this base will be the “International CYBERNICS Center for Development of Advanced Medical Technologies (tentative name)”, which CYBERDYNE plans to develop.

• A new industrial field will be created. This field will focus on solving issues in various areas such as well-being, sport, disaster prevention, and so on, through the development of robots (medical, and non-medical) which utilize cutting-edge technologies.

5. Suggestions for relaxation of regulations:
The following relaxations of regulations are suggested in order to accelerate the launch of developed innovative robotic medical/welfare devices onto the market.

• relaxation of requirements for clinical tests
• relaxation of application requirements for certification of low-risk medical devices
• creation of advance certification system for medical devices
• lifting a ban on treatment partially covered by insurance
• simplification of examination procedures for advanced medical treatments

Ibaraki Pref. HP http://www.pref.ibaraki.jp/news/2014_08/20140829_04/index.html

Tsukuba City HP http://www.city.tsukuba.ibaraki.jp/dbps_data/_material_/_files/000/000/017/264/No114.pdf

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