European Authorized Representative (EAR)
The European Medical Devices Directives require manufacturers, without a registered place of business in the EU to designate an authorized representative. For each device marketed in the EU only one Authorized Representative may be designated. Read more
US Agent and Official Correspondent
The US Food and Drug Administration (FDA) requires foreign manufacturers that import medical devices into the USA to use a local representative, a so called US Agent. (directive: 21 CFR 807.40). Read more
CFDA Agent and Legal Representative
Also in China, foreign manufacturers require a local legal representative to support and liaise in the regulatory processes on the Chinese market. Use Qserve's local offices and local bilingual staff.
Besides our own locations we have a network of local partners that can be used as your independent local and legal representative. A good choice if your local distributor will also be the holder of your product license and changing your distributor means starting the registration process all over again or needing their permission for the transfer to another party.