Regulatory Information / Tools
 Regulatory Affairs information collection sheet from overseas suppliers |
SERVICE
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Regulatory Affairs Consultation
Consultation on regulatory strategy planning, Assistance in consultation with authorities, Support on QMS investigation, etc
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Regulatory affairs operations
Provision of tailor-made overseas liaison services
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Preparation of application documents
Preparation of various documents such as market approval application package, Support on gathering necessary information from manufacturers, etc.
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Business Registration
Support on registration application for Market Approval Holder, manufacturer, sales, and repairs
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Test report translation and test protocol preparation
Translation of test reports written in English, preparation of protocols for non-clinical studies, etc.
ACCESS
About Regulatory affairs Support Organization
“Medical equipment” includes a variety of devices, instruments, and technologies, and they are being developed around the world with the advancement of science.
In order to bring such products to the market, there are many obstacles to over come such as complying to regulations in each country.
Our medical device regulatory affairs experts will provide the services suited for each customer to support from application to insurance application.
Company Information
Nihon Seimei Marunouchi Garden Tower 3F, 1-1-3,Marunouchi, Chiyoda-ku, Tokyo,Japan
TEL +81 3-4405-7514
FAX +81 3-6747-0882
info@rso.or.jp
Established in January 2019