Frequently asked questionsFAQ
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Q.What is the scope of your support for product class classification?
A.
Classes I to IV.
Our company holds a Class 1 medical device manufacturing and sales license, so we can handle all medical devices up to Class IV. -
Q.I would like to obtain a manufacturing and sales license for my own company someday. When that time comes, will the product license be returned to me?
A.
For Class II and above products, it is possible to "succeed" the manufacturing and sales certification/approval at a time of your choice.
However, for Class I products, there will be no "succession" and your company will need to submit a new manufacturing and sales notification. At that time, we will provide you with a copy of the notification. -
Q.We're completely new to the medical device industry and don’t know what steps to take. Can you support us all the way until we’re able to actually start selling?
A.
Yes.
In cooperation with our parent company, Expertner Japan Co., Ltd., we take full responsibility and provide comprehensive support—from foreign manufacturer registration to document preparation, product receipt, and shipment—according to your needs, so please rest assured. -
Q.For now I just want to consult with you, but will there be any consultation fee?
A.
The consultation is free and there are no charges until a contract agreement has been completed.
If you have any questions, please feel free to contact us.