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Provide medical device regulatory consulting in Japan

Proposal Number : 1167257       Provide business supports
Date Date of Registration : Feb 20, 2020
Date of Revision : Feb 20, 2020
Country / AreaTokyo, Japan 
Proposal Category 5404 Various booking and arrangement businesses
5301 Legal and patent related businesses
Target Country / Area All Countries / Areas

*Attention: JETRO shall not take any responsibility for the contents provided by users. Please take note of the fact that JETRO leaves the exactness and reliability of the contents to users' judgment.

Detail Description

Provide medical device regulatory consulting in Japan

We provide the expertise and services needed for regulatory strategies from product development to post-marketing. We provide the services required for each customer, from application for approval, application for marketing authorization, and application of insurance.

We have several consultants who are well versed in regulatory applications for medical devices. We can provide a wide range of consulting services, from manufacturing and marketing licenses for medical devices, to application for approval, and after-market support. Domestic bases are only in Tokyo.

*Service Outline
-Medical devices regulatory affairs consulting
-Medical devices regulatory affairs support
-Application form creation
-License for Medical devices Manufacturing and sales
-Test report translation
-Test protocol creation

*Features of Our Service
There are so many types of medical devices and complicated application forms that it is difficult to enter the market. Our company has several consultants who have experienced various products, and we deal with various medical devices. We provide consulting services.

*Examples of Fees
Business license support, manufacturing and sales notification service: from JPY100,000.
Certification application and approval application creation support service: from JPY1.2 million.
In addition, we have set a fee structure according to the work content and company size.

*Business Results
-Medical device approval / certification (class I-II) application form support
-Medical device manufacturing and sales, manufacturing, business license acquisition support
-QMS construction support
-Foreign manufacturer registration application support

Please contact us for details.

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