Legal representation

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.

Other Countries

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.

Choose an independent legal representative you can trust

In every country you have to choose your legal representative with care. They might have more power over your product than you like.  

Ask yourself a few questions before you sign the contract:

  • Will our name be on the local product certificate or the name of my legal representative?
  • Can we have more than one distributor in this country?
  • If I choose an independent license holder, who will be responsible for the import of my medical device? The license holder or the distributor?
  • How high is the license holder fee and how will this influence my sales margin?
  • What if I want to transfer product certificates to another license holder, do I need permission from the current license holder?

Would you like to use our local offices or one of our international partners as your legal representative? 

Looking for a European Authorized Representative? Qserve's legal entity can act as legal representative...Read more

In need of a US Agent? Qserve's American offices assist with all FDA procedures...Read more

Our legal entities in China and Hong Kong can be used as local representatives...Read more

Using our international partner network? Check our global registration services...Read more

Market access for your device can also be arranged through one of our offices...Read more

Want more information? Get in touch with us

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