Class I, Class II (510K), Class III (PMA) Medical Device
NEW Medical Device
Combination Product
Annual Declaration of Medical Devices
License Renewal
License Change (Transfer, Merge, Site, IFU and Label, Specification…)
Maintenance and Management after approval (Advertising or promotion materials review…)
03 - Other Services Related to Medical Devices
Advertising Application
Trademark Application
Post-market Surveillance (PMS) Report
04 - QSD, License Holder Representation, and License Management
By serving as a neutral third-party license holder, our company is able to provide enhanced flexibility for product circulation and operational arrangements within the market.
