USFDA Medical Device
Back to the previous pageOverview ：Any medical devices that need facility registration, product listing, and 510K application.
Business Challenges ：What if your product is for health promoting or aesthetic medicine only? Do I need a registration with FDA? Whether the requirement from the customer is reasonable or not?
Our service ：
(1) Facility registration
(2) Product listing
(3) 510K
(4) US Agent(not including initial import)
(5) Consulting for project.
How to start ：Please send us the picture of the product.
Why SCG ：We have done with over 200 items including the following : IVD, dental related, Electronic Nerve Stimulator, imaging system, medical device software…..