CDG Certification Limited
CDG Certification Limited
Sector 28, New Delhi, Delhi
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Customised Services

CDG provides different type of registration & CoC services which are specialy customised form client to client.

European Authorised Representative Services for Medical Devices

European Authorised Representative Services for Medical Devices
  • European Authorised Representative Services for Medical Devices
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Approx. Price: Rs 100 / PieceGet Latest Price

Service Details:

Minimum Order Quantity1 Piece
Type of CertificationNew Certification
Type of Service ProviderConsulting Firm
Document Verification ModeDoor Step
Mode Of ReportSoft Copy

 

Why choose CDG as your European Authorized Representative?

CDG has tie up with largest Authorized Representative for medical devices and IVDs, representing more than 1,000 device companies worldwide.

  • Our experienced consultants will review your Technical File, register your medical device or IVD, as required, and respond to any questions or concerns from the Competent Authorities.
  • You will have secure online access to all your documentation and regulatory information, including technical files, labelling information and symbols, language requirements, directives, guidelines, and more.
  • Our vast expertise with European regulations, registering thousands of devices, facilitates a smooth and efficient registration process.
  • We send frequent updates to all our Authorized Representation clients with important regulatory updates focused on Europe.
  • In addition to European offices, our partner maintains offices in the US, UK, Canada, Japan, Korea, Brazil, and many other places worldwide. We can serve you efficiently regardless of your time zone.

 


CDG is the pioneer company providing ‘European Authorised Representative Services’ in India.

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European Authorised Representative Services

European Authorised Representative Services
  • European Authorised Representative Services
Get Best Quote
Approx. Price: Rs 100 / PieceGet Latest Price

Service Details:

Minimum Order Quantity1 Piece
Type of CertificationNew Certification

An (EEA/EU/EC, UK) European Authorised Representative (also called Authorized Representative) is a natural or legal person established in the European Economic Area (EEA, including EU & EFTA) or United Kingdom (UK), who, explicitly designated by a non-European manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives.

  • For the purposes of New Approach directives the Authorised/Authorized Representative must be established inside the Community.
  • The Authorised/Authorized Representative may be addressed by authorities and bodies in the EEA Member States instead of the manufacturer with regard to the latter’s obligations under the New Approach Directives.
  • Commercial representatives of the manufacturer (such as importer, authorized/authorised agent, authorized/authorised distributor), whether or not established inside the Community, are not to be confused with the Authorised/Authorized Representative in the meaning of New Approach directives.
  • The manufacturer remains generally responsible for actions carried out by an Authorised/Authorized Representative on his behalf.

Procedure to appoint an European authorised representative

· The first step is for the manufacturer and the Authorized Representative to sign alegally binding document listing the duties and responsibilities of both sides. (Such a contract is usually required to obtain CE Marking).

· After signing the contract, the manufacturer issues all necessary documentation according to a check-list provided by authorised agent.

· CDG - as your European Authorizes Representative - performs the product registration / notification according to the applicable directives to allow marketing and sales in the European Union.

· Thereafter, Authorised agent can provide, upon request, necessary certificates of registration / notification.

CDG is the pioneer company providing ‘European Authorised Representative Services’ in India.

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RP Kumar (Marketing Manager)
Statesman House, Barakhamba Road
Sector 28, New Delhi- 110001, Delhi, India



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