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					                                          specialised and up-to-date content. As
                                          an approved participant, you will
Successful EU market entry with           receive individual support over a
the CBI’s                                 number of years by means of on-site
export development programme              consultancy, training schemes, market
for medical devices and medical           information, trade fair participation
laboratory equipment                      and business-to-business activities.
                                          Depending on its specific needs, your
To international entrepreneurs, Europe    company may also receive support in
is potentially one of the most            the field of product and production
profitable markets in the world. At the   improvement, quality control, export
same time it also a very complex,         marketing and market entry. On the
competitive and dynamic market. Its       other side of the negotiating table, our
structures are changing constantly and    programme is geared to helping EU
buyer motives today are different than    buyers obtain new supply sources in
they were five years ago. Exporters       developing countries.
are constantly facing new regulations
and market standards, especially with       The CBI: targeted export support
regard to safety, quality, packaging
and the environment. Exporters eager             The Centre for the Promotion of
to access the EU market must prepare      Imports from developing countries
themselves carefully and thoroughly.      (CBI) does what its name suggests - it
                                          assists entrepreneurs in developing
But the time is ripe for export to the    countries in selling to markets in
EU. Rising production costs are forcing   Europe. For this purpose, it has
many European companies to                developed a wide range of support
purchase outside the EU and imports       programmes for many sectors of
have shown major growth in recent         industry. The CBI also supports local
years. This means there are good          business support organisations, for
opportunities for aspiring exporters.     instance by assisting them in training
The only question is: how do you turn     and market research activities. The
them into profitable business?            CBI’s work is financed by the Dutch
                                          government, which means
To help you export to the European        participation costs are limited. Its
market or to improve your export          many years of experience and its
position, the CBI has developed a very    extensive international network make
practical export development              the CBI one of the most important
programme for medical devices and         centres of expertise in export
medical laboratory equipment. The         promotion from developing countries.
programme is run by independent           The Centre was founded in 1971 and is
consultants whose extensive               an agency of the Dutch Ministry of
knowledge and networks throughout         Foreign Affairs.
Europe guarantee high-quality,
                                            Different stages
                                            The programme for medical devices
A powerful development                      and medical laboratory equipment
programme                                   consists of the following stages:
Our new export development
programme for medical devices and           Stage 1. Selection
medical laboratory equipment is meant       Based on the incoming application
for ambitious manufacturers and             forms, a CBI consultant makes a pre-
exporters in the medical industry who       selection of companies that meet the
are eager to expand their export            general admission criteria. Factors
activities in the EU. The programme is      such as export experience, product
accessible for companies that meet the      development, quality assurance
following criteria:                         systems, capacity, products,
                                            production facilities and marketing
   up to 500 employees;                    know-how are taken into
   compliance or the willingness to        consideration.
    comply with EU market                   After pre-selection, a CBI consultant
    requirements;                           will visit your company to carry out a
   internationally accredited ISO          so-called export audit. This audit,
    certification;                          together with a SWOT analysis and
   competitive prices and sufficient       action plan, will assess the possibilities
    production capacity;                    for your company on the EU market
   willingness and capacity to invest in   and provides advice on the necessary
    adaptations of, for instance,           steps for export. Based on this visit,
    product assortment and production       the final selection will be made.
    processes, if and as required by the
    European market.                        Stage 2. Technical support
                                            The export audit and action plan that
For more detailed information on our        have been made during the selection
admission criteria, please visit our        stage, form the basis for further
website: www.cbi.nl/subweb/medical.         technical assistance. In this stage you
                                            will be visited again by a CBI
An easy procedure                           consultant and you will receive
Each CBI export development                 feedback and support on all crucial
programme operates on a step-by-            factors of the export audit, such as
step approach that is clear and simple      your production facilities and capacity,
to follow. Our programmes include           the organisation of production and
certain regular features but are also       export, price, packaging, marketing,
flexible and tailored to participants’      management, product features,
individual needs.                           international competition, certification,
                                            environmental, safety, quality and
                                            consumer health regulations, as well
                                            as labour conditions.
The implementation of the action plan          a briefing prior to the fair about the
is further supported by distant                 latest market developments;
guidance and coaching from the CBI             advice on the best market
consultant.                                     approach;
A third visit of the consultant, later in      professional assistance in preparing
the programme, should secure that               your presentation;
your company complies to the                   hands-on consultancy during the
technical standards of the EU markets.          fair.

Stage 3. Export marketing training          In principle participants may be invited
In the third stage, participants are        to take part three times in the trade
invited to a so-called EXPRO seminar        fairs.
in Rotterdam, the Netherlands. The
seminar consists of lectures,               Throughout Stage 4, your company
discussions, case studies and practical     will also be actively involved in other
assignments in the areas of export          B2B activities carried out by CBI.
marketing, management and sector-
specific topics. During the seminar,        Stage 5. Consolidation
participants may also visit a European      In the year following each trade fair
trade fair and a leading buyer and          participation the CBI will help you
receive individual counselling. Before      solidify and expand business contacts.
the seminar, the CBI makes use of the
Internet for preparatory e-learning         Participation costs
sessions.                                   The CBI is a development organisation
                                            operating in a non-commercial market
Stage 4. Access to the market               and does not require participants in its
Supported by the CBI, you will then be      programmes to cover all costs.
encouraged to attend the biggest            Participants in an export development
trade fair in the industry, Medica. Here    programme do pay a non-refundable
you will not only make personal             participation fee of € 1,000,--.
contact with potential partners, but        The fee is collected as soon as the CBI
also acquire first-hand and in-depth        has determined that the company is
market experience. In addition,             suitable for enrolment. This occurs the
participation at more specialised trade     moment an understanding has been
fairs or medical congresses may also        reached between the CBI and the
be offered.                                 company on the measures that are to
To help you make maximum use of the         be taken, the assistance the CBI will
trade fairs, the CBI will provide:          offer throughout the programme, and
                                            the expected results. Usually this
   publicity and invitations through       agreement is formulated after a CBI
    mailings and telemarketing;             consultant has visited the company to
   a stand of approximately 9-12 m²;       carry out the export audit (after stage
                                            1).
Apart from this ‘registration fee’,
companies do not need to pay for CBI       More information
services.
International travel expenses incurred     For more information about the CBI,
by participants attending trainings in     the export development programme
Europe may be partially remunerated.       for medical devices and medical
If the CBI arranges lodging,               laboratory equipment, or to download
transportation and meals participants      an application form, please visit our
will not be charged. This arrangement      website at www.cbi.nl/subweb/medical
also applies if the CBI conducts           On the site you will also be able to
training activities in your region. The    check whether your country is
regular expenses made by the CBI           qualified for programme entry.
during the programme are not charged
to participants either. Other expenses     You may also return the enclosed
not mentioned here must be covered         application forms by post or fax (+ 31)
by participants.                           (0)10 411 40 81. You can also send an
                                           e-mail to jnijenhuis@cbi.nl. We will
First-time trade fair exhibitors within    then send you the information you
the CBI’s programmes are provided          require as soon as possible.
with a completely furnished, free-of-
charge stand in the CBI pavilion.          CBI,
Second-time exhibitors are charged         EDP Medical devices and medical
the rent for the space they use.           laboratory equipment
Third/time exhibitors are charged an
additional € 75,-- of build-up costs for   Postal address:
each square metre of stand space they      PO Box 30009
use.                                       3001 DA Rotterdam
                                           The Netherlands
References
In the past, the CBI has conducted a       Telephone: + 31 10 20 13 437 / 34
number of other successful export          Telefax:     + 31 10 41 14 081
development programmes in the field        e-mail: jnijenhuis@cbi.nl / cbi@cbi.nl
of medical devices. The pending            website: www.cbi.nl
programme (which will end in 2007)
has so far lead to a combined export       Office address:
turnover of about € 30 million for 38      Beurs WTC 5th floor
participants.                              Beursplein 37, 3011 AA Rotterdam
Next to medical devices, CBI is            The Netherlands
carrying out export development
programmes in some 20 other sectors.
              List of possible products and corresponding HS-codes for the
            Export Development Programme for Medical devices and medical
                                   laboratory equipment

1    Wadding, gauze, bandages
     3005 10       Adhesive dressings and other artcl having adh lay, ceramic woundcare
                   products
     3005 90       Wadding, gauze and similar articles etc nesoi
     4818 90 10    Non-woven materials, articles of paper pulp, paper, cellulose wadding or
                   webs of cellulose fibre of a kind used for surgical, medical of hygienic
                   purposes.
2    Latex medical disposables
     4015 11       Surgical articles (gloves) of apparel and clothing accessories of vulcanised
                   rubber, other that hard rubber, latex urology catheters for internal use,
                   latex urine catheters for external fixation.
     4015 19 90    Gloves, of vulcanised rubber other than hard rubber (excl. household and
                   surgical gloves)
3    Syringes, needles and catheters
     9018 31       Syringes, with or without needles; pts & access
     9018 32       Tubular metal needles & needles for sutures &parts
     9018 39       Med needles. nesoi, catherers made of polymer materials etc and parts etc
4    Wound closure products
     3006 10       Sterile surgical catgut, similar sterile mater etc
     3907 20 11    Synthetic suture material, made of polyethers
5    Electro-diagnostic apparatus
     9018 11       Electrocardiographs, and parts and accessories
     9018 19       Electro-diagnostic apparatus nesoi, and parts etc.
6    X-ray & other radiation equipment
     3006 30       Radio opaque, preparations for x-ray examinations; diagnostic reagents for
                   administration to patients
     9022 13       X-rays apparatus, dental use, nes
     9022 14       X-rays apparatus, medical/surgical/veterinary use nes
     9022 21       Medical apparatus using alpha, beta or gamma radiation
     9022 30       X-ray tubes
7    Surgical instruments
     9018 90       Instruments & appliances for medical surgical dental vet, nesoi
8    Dental instruments and appliances
     9018 41       Dental drill engines and parts and accessories
     9018 49       Dental instruments and appliancs nesoi
9    Ophthalmic instruments
     9018 50       Ophthalmic instruments
10   Massage and psychological aptitude-test apparatus
     9019 10       Massage and psychological aptitude-test apparatus
11   Orthopedic appliances
     9021          Orthopedic appliances; artificial body parts; hearing aids; parts &
                   accessories crutches, surgical, belts, trusses, splints, bone plates /screws
                   /nails, artificial teeth, pacemakers
12   Measuring devices
     9026          Measuring devices for checking flow, level, pressure of liquids and gases
13   Instruments for physical or chemical analysis
     9027 40       Exposure meters
     9027 50       Instruments nes using optical radiations
     9027 90       Microtomes, parts of scientific analysis equipment
14   Sheath contraceptives of vulcanised rubber (i.e. condoms)
     4014 10       Sheath contraceptives of vulcanised rubber (i.e. condoms)
15   Medical, surgical, dental or veterinary furniture
     940290        Medical, surgical, dental furniture; similar chairs operating tables, hospital
                   beds, dentists chairs
16   Invalid carriages
     8713          Invalid carriages
     Application form for EDP Medical devices and medical laboratory equipment
     CBI Exporter’s company profile (ECP)                                                          Confidential
     Please complete in English by typewriter
1.   Company name       :
     Contact person Mr.       Mrs.   Miss                          Function
     Last name                                                     Initials
     Office address                                                Mailing address
     Address                                                       Address
     Postal code/City                                              Postal code/City
     Province/state                                                Province/state
     Country                                                       Country
     Phone                                                         E-mail address
     Fax                                                           Internet address
     Nearest airport
     city
     Distance km
     Travelling time
     Production Unit 1                                             Production Unit 2
     Address                                                       Address
     Postal code/City                                              Postal code/City
     Nearest airport                                               Nearest airport city
     city
     Distance Km                                                   Distance Km
     Travelling time                                               Travelling time
2.   Established as       Manufacturer/producer        Exporter          Export Agent      Service org.     Other
3.   Legal status         Private company              Partnership       State-owned corp  Cooperative      Other
4.   Established in year:               Total no. of permanent employees: Total no. of temporary staff:
5.   Branch offices in Europe (city/country):

6. Representatives and/or agents covering The Netherlands:

7. Parent company:     (name, city, country):
   Subsidiaries:       (name, city, country):
   Foreign ownership (……..%, name, city, country):
   Joint ventures:     (name, city, country):
8. Products/services that you (want to) Production capacity /       Export capacity /    Harmonized System
   export:                               year:                      year                 (H.S.)
                                                                                         Code no. (If known)




9. Exports to The Netherlands (last       Yes       No, if yes:
   3 years)
   Year(s)     Value US$      Buyer                               Tel. Nr.              Products/services
   Page 2 application form
10 Exports to other countries during the past 3 years
 .
   Products/services description           Year         Country (not region)                 Value US$




11 Are any of your products manufactured under             Yes      No
 . license agreement?
   If yes, mention product(s), “licensers”/country,
   expiry date:                                            Yes      No
   Does this agreement prohibit exporting to Europe?
   If yes, mention product(s) countries, expiry date
12 Previous or current participation in programmes of CBI and/or other European Import Promotion Organizations
 .
   Year     Event                                        Name Import Promotion Organization:

13 Type of relation sought:
 .  Impo      Agency     Contract               Co-maker         Private        Joint           Joint venture
    rt                   manufacturing          ship             labeling       venture         finance
                                                                                technology
14 Person submitting the above information:
 .
   Name:                                    Function:                                  Date:



    Please proceed with Annex 1 and 2 of the Application form
                                                                        Annex 1
                             EXPORT AUDIT FORM
   Export Development Programme for Medical devices and medical
                       laboratory equipment


Company name:_______________________________________________




 1. Basic financial data covering a span of the past three years: What was
    your enterprise’s current ratio (current assets as a percentage of current
    liabilities), net profit margin (profit before interest as percentage of
    turnover) and solvability (own capital as percentage of total assets)?


  Year     Current ratio          Net profit margin    Solvability




 2. Does your enterprise work according to a written business plan?
                          Please submit a copy of your business plan




 3. Did your enterprise generate export turnover during the past three
    years?


   No


 4. Did your enterprise add improved or new products to its product line
    during the past three years?




 5. Did your enterprise conduct or outsource any product innovation-related
    research during the past year?
6. Does your enterprise have its own R&D (Research & Development)
   division?




7. Quality assurance systems (for example Total Quality Management)
   serve as a guarantee for constant quality. Does your enterprise employ
   any documented quality assurance system?




8. Does your enterprise hold any internationally recognized quality- or
   safety certification, such as ISO, HACCP or CE for example?
                       Please submit a copy of same




9. Does your enterprise have any Western-European, Canadian, American
   (USA), Australian or Japanese multinationals located in your own
   country as customers?
                Please mention the names of these multinationals:
                 ______________________________________________
                 ______________________________________________
                 ______________________________________________




10. Are you aware of relevant market requirements in Europe in the field of
    environment, health, safety and social issues, which apply to your
    export products?




11. How many of your enterprise’s employees are involved in export
    management and administrative processing of export contracts on a
    daily basis?
 No. of employees       …
12. Does your enterprise have an export budget to finance export
    promotion?




13. Suppose your enterprise had to borrow capital. Would your enterprise
    currently meet the requirements (in terms of adequate cash flow,
    reputation, profitability, etc.) to obtain borrowed capital (loans) from a
    bank/financial institution?




14. Did your enterprise gather information as to whether your country’s
    government stimulates export of your particular product(s) (for instance
    via granting subsidies, training, tax credits, etc.)?




15. Did your enterprise gather information as to whether your country
    maintains international trade agreements that are relevant for the
    export of your products?




16. Does your enterprise employ the services of specialized external
    advisors (other than CBI) in respect of drafting and realizing your export
    intentions?




17. Did your enterprise visit or exhibit in any international trade fairs during
    the past three years?
                               Please indicate which trade fairs
                                     Please indicate which trade fairs
18. Is your enterprise registered with any Business Support organization(s)
    or similar organization(s)?
          Please indicate which organization(s)______________________




19. Does your enterprise have a written export plan?
                  Please submit a copy of same
                  Please answer the following questions:

              a. Why do you intend to export to the EU?




              b. What are your expectations of exporting to the EU (specify
                 countries, potential clients, products and expected turnover
                 for the next three years)?
            c. What activities are planned to realize these expectations?




20. Is your enterprise willing to invest in product or process adaptations to
    be able to match international market requirements, such as specific
    customer demands or international environmental conditions?




21. How many of your sales personnel write and speak the English
    language?
 Number of employees …


22. Does your enterprise employ staff whose background includes study or
    working experience in Europe, the US or Canada?


             han 1 year of working experience




23. Is your enterprise’s sales staff capable of negotiating contracts/business
    terms in the international arena?
                                                                                   Annex 2
                            SUPPLY INFORMATION FORM
        Export Development Programme for Medical devices and medical
                                laboratory equipment



        Company name:_______________________________________________


1. PRODUCT:


Give a detailed description of the products you manufacture (only if you do not have a
product list available):




Describe the raw materials, spare parts, components used in production:




Indicate the product(s) end-use/application(s):




2. MANUFACTURING PROCESS:


What is your manufacturing process:
       Moulding
       Heat blowing
      Extrusion
      Assembling
      Forging and welding process
      Dipping & Chlorination
      Other, specify


In case of sterile products, which sterilization method is used:
      Steam
      Ethylene Oxide
      Gamma Irradiation
   Is process validated? Yes / No                              By whom:




2. PRODUCTION CAPACITY:


Is your company capable to expand its production capacity ?
- in the short run yes / no , specify:




- in the long run yes / no , specify:




3. PACKAGING


Describe and specify the packaging materials used:
CHECKLIST OF INFORMATION TO BE SENT FOR APPLICATION FOR THE CBI
PROGRAMME For Medical devices and medical laboratory equipment

Please note that only complete applications will be handled by CBI. In order to make
a proper evaluation of the possibilities of your company we would request you to
send full information as indicated below:(mark if enclosed):

     completed exporters’ company profile
     completed Export Audit Form
     supply information form if requested
     brochure/catalogue/photographs/product data sheets
     Price list /trade offer
     copy of any internationally recognised quality- or safety certification, e.g.
      ISO, HACCP or CE (if available)
     annual report (if available)
     organisation chart (if available)
     Business plan (if available)
     Export plan (if available).

The application can be sent by e-mail / fax, original documents by (express)mail /
courier service

ADDRESSES FOR SENDING YOUR APPLICATION:
By mail  : CBI                        By courier: CBI
         EDP Medical devices and      EDP Medical Devices
         Medical laboratory equipment Medical laboratory equipment
         P.O. Box 30.009              Beurs WTC, 5th Floor
         3001 DA ROTTERDAM            Beursplein 37
         The Netherlands              3011 AA ROTTERDAM
                                      The Netherlands

By fax       :      +31-10-4114081
By e-mail    :      jnijenhuis@cbi.nl / cbi@cbi.nl
(Please see to it that in your e-mail your complete company details are mentioned:
name of your organisation and complete address, including phone, fax, email
number)

Programme manager               :      Jan Nijenhuis

				
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