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What Is Why Need Difference Why Wellkang Questions & Answers FREE guide on CE marking of medical devices MDD/IVDD
medical devices EU/EC European Authorised/Authorized Representative

As of 21 March 2010, a Single EEA/EU/EC European Authorised/Authorized Representative must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA & other EEA authorities by world-leading CE Marking
Specialists based in London/UK. Click here to get FREE Guide Now!

Export to Europe?  Let Wellkang be your European Authorised/Authorized Representative!

  • Why do you need a European Authorised/Authorized Representative?
  • Why must the manufactures of medical devices appoint a European Authorised/Authorized Representative?
  • Why is the Authorized Representative different from the importer/distributors ?
  • Why choose Wellkang?
  • How can Wellkang help you?
  • What are included in Wellkangs EEA/EU Authorized Representative Service?
  • 11 benefits by appointing Wellkang as your EEA/EU Authorized Representative?
  • 3 unique benefits offered by Wellkang that are not available from others?
  • How much does it cost? Competitive Price List!
  • How to contact Wellkang?


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    Why choose Wellkang?

    Wellkang Group of Companies- a world leading regulatory consulting group in: CE Marking WEEE registration, RoHS compliance and solutions; US FDA affairs incl. 510(k) PMN submission, UL mark; and China's CCC Mark & China RoHS compliance and solutions. Wellkang help worldwide exporters to gain global market access. Wellkang have offices in the USA, Europe and Asia. As a world-leading business-to-business consulting firm, Wellkang group is proud of that we have served clients/customers from more than 100 countries among which there are Fortune 500, multinational companies as well as governmental authorities and international organizations. Wellkang has been placed and highly ranked among world's top Import/Export Consulting Firms selected by the world's most prestigious web directories such as Google Web Directory, and top search engines and hundreds of other directories.

    Wellkang has been recommended as service provider to local exporters by varies governmental export promotional agencies from different part of the world


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    How can Wellkang help you?

    Wellkang's mission is to provide a comprehensive range of business services aimed at assuring the European product conformity. The in-depth expertise of our professionals and an extensive working experience in a wide industrial spectrum enable us to achieve this goal. Wellkang strives to establish a close, trusting relationship with our clients based on proven performance and total dedication to their products.

    1. EU Documentation and Standards Delivery Service.
      • 1.1 EU Product Directives
      • 1.2 European Standards
      • 1.3 Other EU Official Documents
    2. Technical Consulting Service
      • 2.1 Technical Advice on Compliance Engineering
      • 2.2 Safety and Risk Assessments
    3. Compliance Testing Service
      • 3.1 Pre-compliance testing arrangement
      • 3.2 Full-compliance testing arrangement
    4. Technical Documentation Service
      • 4.1 Technical Files (Technical Documentation):
        guiding you preparing this document.
      • 4.2 EC Declaration of Conformity:
        guiding you preparing this document, we have different models in several languages.
    5. Labeling and Document Translation
      (We can arrange the translation from English into the official language(s) of every EU member state)
      • 5.1 Users Manual and Installation Instructions
      • 5.2 Labeling Advice and Translation
    6. EEA/EU Authorized Representative Service
      • 6.1 Product Registration:
        We can register your product in EEA for the first time and get your product a Certificate of Registration.
      • 6.2 Renewal and Update Product Registration:
        The product Certificate of Registration is valid for one year only and must be renewed annually. The information about the product must be updated whenever it changes and at least once a year when renew the product Certificate of Registration.
      • 6.3 Keep Your Technical Files:
        We store and update the Technical Files of your products sold in Europe, and makes them available timely to the appropriate surveillance/vigilance authorities upon request.
      • 6.4 Legislation Monitoring:
        We monitor and report on new developments in European product legislation relevant to your products.
      • 6.5 Vigilance and Incident Reporting:
        We assist with product vigilance and incident reporting.
      • 6.6 Product Recalls and Advisory Notices:
        We assist with Product Recalls and the issuing of Advisory Notices

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    11 benefits by appointing Wellkang as your EEA/EU Authorized Representative?
    1. Wellkang offers you a foothold in Europe: a name, an address, a telephone and fax number. Save you the cost of opening an office in Europe.

    2. Make the EEA market entrance simple: You need only ONE European Authorized Representative like Wellkang in the entire EEA (28+3) European countries to deal exclusively with the CE marking regulatory issues, whereas you may have as many as you want importers, distributors and sales representatives in Europe.

    3. Gain new EEA market: as long as your products are affixed with CE Marking, importers, distributors and sales representatives will be easier to come by as they do not have to deal with complex conformity issues and product certification which require professional in-depth expertise. Your distributor may excel in marketing and sales, but is he equipped or even interested in handling regulatory and legal issues?

    4. Wellkang acts as the contact person for market surveillance authorities and end users when conformity issues are concerned.

    5. Wellkang stores and updates the technical files of the products sold in Europe, and makes them available to the appropriate authorities upon request.

    6. Wellkang registers your products (Class I Medical Devices) with the appropriate authorities. Wellkang provides advice on the implementation of European technical regulations and guides clients through the certification procedures.

    7. Wellkang monitors and reports on new developments in European product legislation relevant to clients.

    8. Wellkang offers product vigilance and incident reporting.

    9. Wellkang assists with product recalls and the issuing of advisory notices.

    10. Wellkang's annual fee is fixed and includes all services; no additional hourly rates are charged, no hidden fees.

    11. Keep your business secrets confidential: it is Wellkang that keeps your technical files, not the European distributor(s) who might turn(s) into one of your future competitors.

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    3 unique benefits Wellkang can offer that are not available from other EEA/EU representation providers?
    1. As a world-leading business-to-business consulting firm specialized in CE Marking, Wellkang is proud of that we have served clients/customers from more than 100 countries among which there are Fortune 500, multinational companies as well as governmental authorities and international organizations. One of our main website, www.CE-marking.org, has received more than 15,000,000 (15 Millions) visitors and been constantly ranked on top for search term CE marking by major search engines such as: Google, Yahoo and DMOZ. Wellkang has been placed and highly ranked among world's top Import/Export Consulting Firms selected by the world's most prestigious web directories such as Google Web Directory, and top search engines and hundreds of other directories.
    2. new Our Marketing Department will design an One-page website (we call it Identity Page) with brief introduction of your products together with the copy of your Certificate of Registration, if applicable. This page will be in several major European languages in order to show your products' accreditation to both the CE Marking Vigilance/Surveillance Authorities and your importers, distributors and customers. This page will be published at website www.CEmark.info and the URL will be:
      http://www.CEmark.info/lvd/YourProduct.html, or
      http://www.CEmark.info/mdd/YourProduct.html, or
      http://www.CEmark.info/machinery/YourProduct.html, or
      http://www.CEmark.info/ppe/YourProduct.html, or
      http://www.CEmark.info/toy/YourProduct.html, etc.
    3. new We will regularly submit your Identity Page to major search engines. Therefore, your potential buyers will have more chances to find your products.

    The European Economic Area (EEA):

    The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market.

    Switzerland is neither an EU nor EEA member but is part of the single market.


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    FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices
    About CE Marking:


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