Local Representation

Stay independent and flexible

LOCAL REPRESENTATION

Are you in need of a Local representative?

Would you like to use our local offices or one of our international partners as your local representative? In every country, you have to choose your representative with care. They might have more power over your product than you like. 

 

 

 

EU, US, CHINA AND OTHERS

Legal representation where you need it

 

European Authorized Representative (EAR)

Looking for a European Authorized Representative? The European Medical Devices Directives require manufacturers, without a registered place of business in the EU to designate an authorized representative.

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UK Responsible Person 

Looking for a UK Responsible Person? In September 2020, the UK Government published a new guidance document for manufacturers that place medical devices on the British market. This document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.

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US Agent & Official Correspondent Services for FDA Registered Establishments

All FDA registered establishments must appoint an Official Correspondent and, for all establishments located outside of the United States, a US Agent must also be designated. 

Qserve’s US office assists in navigating FDA’s procedures for these vital roles.

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NMPA Agent and Legal Representative

Looking for a legal representative in China and Hong Kong? 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.

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Legal representation in 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.

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How can we help you? Contact us