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CBI EXPORT GUIDELINES

  • Active Implantable Medical Devices (AIMDD)
    Directive 90/385/EEC

  • Dangerous Substances and Preparations
    Directive 93/21/EEC

  • Medical Devices Directive (MDD)
    Directive 93/42/EEC

  • In Vitro Diagnostic Directive (IVDD)
    Directive 98/79/EC

For information on legislation for medical devices and disposables, go to ‘Search CBI database’ at http://www.cbi.eu/marketinfo, select your market sector and the EU in the category search, click on the search button and click on legislative requirements for an overview of all documents on legislation. It includes additional information on packing, marking, labelling, and non-legislative requirements as well. Non-legislative requirements, for example, include social and environmental codes of conduct that are of growing importance to the European market and to international trade.

Additional information can be found on the following websites:

Meet industry specific challenges

The medical devices and disposables market is a complex industry. Exporters of medical devices, for example, have significantly different challenges to contend with than exporters of medical disposables. One of these challenges is dealing with the fierce competition between suppliers in the EU market and the strong relationships between suppliers and buyers. It will therefore be important for exporters from DC to invest in exploring market opportunities and building relationships with possible trading partners.

In the medical device market DC exporters are competing with large European manufacturers that invest a lot of time and money in the research and development of new technologies and innovative products. In most cases, DC manufacturers will not be able to invest similar amounts of resources. Moreover, information on the demands and developments of the European market will be harder to come by without a good network in the market.

Another specific challenge facing the medical devices and disposables market in the EU are the restrictive measures being implemented on health care systems. Governments of EU Member States are reforming their policies regarding the reimbursement of medical devices and disposables. Changes in the reimbursement policy will affect the demand of hospitals and group purchasing organisations for specific products. It will therefore place special demands on developers and manufacturers.

Because there are big differences in the reimbursement policies of the various EU Member States it is important to conduct further research to see where you stand. A good starting point are the CBI sector surveys covering the market in individual EU countries.

Prepare your company to be export ready

  • Do the Export Readiness Checker at http://www.cbi.eu/tools ( ‘export checker’);

  • Have a first look at the online exercise to write an Export Marketing Plan (EMP Builder) at http://www.cbi.eu/tools ( ‘Export Marketing Plan’). Familiarize yourselves already with the demands and requirements of exports;

  • CBI’s ‘Export Planner’, in particular chapter 1 and 2 (http://www.cbi.eu/marketinfo ‘search CBI publications’ export manuals).

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