Local Representation
Are you in need of a Local Representative?
Most countries require a foreign manufacturer to appoint an authorized local representative or license holder if they want to market their devices. With our own local entities and international Agents and Reps, we can act as a fully established legal company with a physical address and serve on behalf of your company as an independent party without a conflict of interest between Qserve and the manufacturer.
European Authorized Representative (EAR)
Looking for a European Authorized Representative (EC Rep)? The European Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require manufacturers without a registered place of business in the EU to designate an authorized representative.
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UK Responsible Person (UK RP)
Since the UK left the EU on the 31st of January 2020 (Brexit), manufacturers without an establishment in the UK must appoint a UK Responsible Person (UK RP). The UK Responsible Person acts on behalf of the foreign manufacturer for all communications with the MHRA, including the registration.
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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 the FDA’s procedures for these vital roles.
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NMPA China Agent
Looking for a legal representative in China? The NMPA requires any foreign manufacturers who do not have a legal entity in China, to appoint one China Agent when they initiate the product registration process. Use Qserve's local office and multilingual experts.
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Local 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.
Contact us for other countries