|As of 21 March 2010, a Single EEA 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!
Do you export to Europe? Let Wellkang Group help you! Let a world leading consulting group be your professional & reliable European Authorised/Authorized Representative for CE marking (CE mark) of Medical Devices (MDD), Personal Protective Equipment (PPE), Low Voltage Electrical Equipment (LVD), Electromagnetic Compatibility (EMC), REACH Only Representative, WEEE and RoHS, Cosmetics, Toys, etc.
Wellkang Group is a world leading consultancy group specialized in global regulatory affairs such as: European Union & EFTA product safety requirement- CE Marking; REACH; WEEE and RoHS compliance and solutions; European regulations on cosmetic products; US FDA compliance including Food registration, Medical device 510(k) PMN submission; UL mark; China Compulsory Certification- CCC Mark & China RoHS compliance and solutions, etc.
Wellkang help worldwide exporters to gain global market access. Wellkang have offices in Asia, Europe and America. A world leading consultancy offers you excellent services at very competitive prices!
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.
- EU Documentation and Standards Delivery Service.
- 1.1 EU Product Directives
- 1.2 European Standards
- 1.3 Other EU Official Documents
- Technical Consulting Service
- 2.1 Technical Advice on Compliance Engineering
- 2.2 Safety and Risk Assessments
- Compliance Testing Service
- 3.1 Pre-compliance testing arrangement
- 3.2 Full-compliance testing arrangement
- 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.
- 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
- European (EEA/EU) Authorised/Authorized Representative Service
- 6.1 Use of Wellkang's Name & Address:
By appointing Wellkang as your European Authorised/Authorized Representative, you are allowed to print Wellkang's Name and Address on the packaging, labeling and sales literature of your CE-marked products in order to comply with the EU directives.
- 6.2 Product Registration:
As your European Authorised/Authorized Representative, we can register your MDD/IVD products in EEA with the Competent Authority (CA).
- 6.3 Renewal and Update Product Registration:
The product registration information must be updated regularly or whenever it changes. Wellkang will update your information with the Competent Authority (CA), where applicable.
- 6.4 Keep Your Technical Files:
As your European Authorised/Authorized Representative, we store and update the Technical Files of your products sold in Europe. The Technical Files may be inspected at any time by the Competent Authorities for a period ending at least five (5) years after the last product has been manufactured.
- 6.5 Legislation Monitoring:
We monitor and report on new developments in European product legislation relevant to your products.
- 6.6 Vigilance and Incident Reporting:
As your European Authorized/Authorised Representative, we assist with product vigilance and incident reporting.
- 6.7 Product Recalls and Advisory Notices:
As your European Authorized/Authorised Representative, we assist with Product Recalls and the issuing of Advisory Notices
How can you benefit by designating Wellkang as your EEA/EU Authorised/Authorized Representative?
- 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.
- Make the EU market entrance simple: You need only ONE European Authorized/Authorised Representative like Wellkang in the entire 27+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.
- Gain new EU 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?
- Wellkang acts as the contact person for market surveillance authorities and end users when conformity issues are concerned.
- Wellkang stores and updates the technical files of the products sold in Europe, and makes them available to the appropriate authorities upon request.
- 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.
- Wellkang monitors and reports on new developments in European product legislation relevant to clients.
- Wellkang offers product vigilance and incident reporting.
- Wellkang assists with product recalls and the issuing of advisory notices.
- Wellkang's annual fee is fixed and includes all services; no additional hourly rates are charged, no hidden fees.
- 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.
* 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 a member of EFTA, but neither an EU nor EEA member. It however is still part of the single market.
For more information, please visit our Questions and Answers section, or you can click here now for a quotation.
About CE Marking:
About Medical Devices
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