Export Coaching Programme for
Medical Devices and Laboratory Equipment
For successful EU market entry
Export Coaching Programme for
Medical Devices and Laboratory
Equipment
Project Document
Introduction
The demand in the sector of medical devices
and laboratory equipment is growing on the
European market. This is due to an
expanding European population, increasing
demands for care of the ageing, an active
lifestyle of the population, and technological
innovations. Growth occurs especially in the
new EU member states, because of the
increase in public and private health care
expenditure. The more established markets
are characterized by a slower, but stable
growth.
This Export Coaching Programme (ECP) aims
to assist producers and exporters of medical
devices and laboratory equipment in
developing countries in entering the European
market and establishing sustainable trade
relationships with European buyers. It will be
carried out by the Centre for the Promotion of
Imports from developing countries (CBI).
Companies are encouraged to apply for the
programme if they meet the selection criteria.
Through a step-by-step approach, selected
companies are given intensive support in
order to get a firm and durable foothold on
the EU market. Furthermore, they will receive
the relevant market survey(s) published by
CBI. Depending on the needs and
requirements, selected companies will be
coached by a team of sector experts in the
field of production, quality control,
management, export marketing and market
entry. In order to foster market entry,
collective trade fair participations in a leading
trade fair in Europe will be part of the
programme. Participation in this six year
programme requires a onetime payment of a
non-refundable commitment fee of € 1000 to
CBI.
Why Europe?
With imports from developing countries
growing with double digit rates within the first
half of this decade, the European market is
one of the most interesting markets for
exporters of medical devices and laboratory
equipment. Between 2003 and 2007, CBI
target countries realized a 15% yearly
increase in their exports of medical devices
and laboratory equipment.1 The economic
crisis has created a new landscape for
international traders. The sector of medical
devices and laboratory equipment is not as
sensitive to economic fluctuations as other
markets. The crisis may even be an
opportunity for exporters since EU
manufacturers will increasingly look for ways
to work together in order to reduce costs.
CBI: targeted export support
The Centre for the Promotion of Imports from
developing countries (CBI) does what its name
suggests - it assists entrepreneurs in
developing countries in selling on markets in
Europe. For this purpose, it has developed a
wide range of support programmes for many
different industries. The CBI also supports local
business support organisations, for instance by
assisting them in training and market research
activities. The CBI’s work is financed by the
Dutch government, which means participation
costs are limited. Its many years of experience
and its extensive international network make
CBI one of the most important centres of
expertise in export promotion from developing
countries. The Centre was founded in 1971 and
is an agency of the Dutch Ministry of Foreign
Affairs.
Although Europe is potentially one of the
most profitable markets in the world, it is also
a complex, competitive and dynamic market.
The increasing number of market standards,
especially with regard to safety, quality,
packaging, the environment and competition
from European companies may seem
obstacles to export.
There are, however, also many opportunities
for companies that want to export to the
EU/EFTA markets. Rising production costs are
forcing many European companies to
1 For an overview of all trade statistics used as input to
this document: www.cbi.eu/exportpotential.
1
Export Coaching Programme for
Medical Devices and Laboratory Equipment
For successful EU market entry
purchase outside the EU and imports have
shown major growth in recent years. These
developments create very lucrative market
niches for exporters from developing
countries.
Highlights previous ECP for
medical devices and laboratory
equipment
 30 companies CE and ISO certified
 Companies at Trade Fair Medica
 A 50% increase in employment
since participation
 A combined export turnover for 24
participants of €35,017,000.
Who are we looking for?
Our new ECP for medical devices and
laboratory equipment is aimed at talented
and ambitious producers or exporters who
are eager to expand their activities in Europe.
The programme is accessible for companies
that meet the ECP selection criteria and the
general CBI selection criteria.
ECP selection criteria
1. Your company must be based in one of the
CBI target countries. For the list of countries:
www.cbi.eu/countries;
2. Your company must offer a product within
the range of the ECP medical devices and
laboratory equipment:
 Wadding, gauze, bandages
 Latex medical disposables
 Syringes, needles and catheters
 Wound closure products
 Electro-diagnostic apparatus
 X-ray & other radiation equipment
 Surgical instruments
 Dental instruments and appliances
 Ophthalmic instruments
 Measuring devices
 Instruments for physical or chemical
analysis
 Sheath contraceptives of vulcanised rubber
(i.e. condoms)
 Medical, surgical, dental or veterinary
furniture
 Invalid carriages
For the complete list of products and HS
codes see Annex 1 (page 5-6) or go to
www.cbi.eu/mdle.
Excluded are: pharmaceutical products and
veterinary products.
General CBI selection criteria
For a list of general CBI selection criteria, visit
our website: www.cbi.eu/ecpcriteria
A powerful and practical programme
The programme consists of 3 clear and
simple phases, all essential to become a
successful exporter to the European market:
Phase 1: Application, pre-selection
and export audit
Based on the incoming application forms, CBI
makes a pre-selection of companies that
meet the selection criteria and are eligible for
participation. Once your company is pre-
selected, a sector expert will visit you to carry
out a so-called export audit in which factors
crucial to export success will be assessed.
These factors include product types and
quality, compliance with market access
requirements, quality control systems and
marketing and management skills. CBI will
narrow down the selection of participants on
the basis of the audit. The export audit also
leads to an action plan, describing areas of
improvement, required measures and
deadlines. Companies that agree with the
action plan and have paid the upfront fee
continue to:
Phase 2: Technical assistance
Technical assistance offered within the ECP
consists of visits by sector experts, distant
guidance and an EXPRO seminar.
While implementing their own action plan,
selected companies will be visited by a sector
expert several times for more assistance in
the field of improvement of the production
and export process and compliance with
market standards. This expert possesses
extensive knowledge on the European
market, which will be at the disposal of your
company.
During the entire technical assistance phase a
team of experts will render distant assistance.
The experts can advise your company and
2
Export Coaching Programme for
Medical Devices and Laboratory Equipment
For successful EU market entry
give it access to their network and knowledge
in any field deemed necessary.
In addition to this, all participants are invited
to the EXPRO seminar in the Netherlands, an
in-depth familiarization with the distribution
chain. The EXPRO seminar consists of field
visits, lectures, discussions, case studies and
practical assignments in the areas of export
marketing, management and sector-specific
topics. At the end of the seminar you will
have developed your own Export Marketing
Plan for the European market. In writing this
you will receive (individual) counselling during
the seminar. The seminar will take place in
the third quarter of 2010.
Phase 3: Market access
When technically ready for market entry, you
will be invited to attend a major trade fair
such as Medica in Germany2 . The choice of
trade fair will depend on your specific product
and market entry options. At the trade fair
you will not only make personal contact with
potential partners, but also acquire first-hand
and in-depth market experience.
To help you make maximum use of the trade
fairs, CBI will provide:
 publicity and invitations through mailings
and telemarketing;
 a stand of approximately 6-9 m²;
 a briefing prior to the fair about the latest
market developments;
 advice on the best market approach;
 professional assistance in preparing your
presentation;
 hands-on consultancy during the fair.
In principle participants may take part in
trade fairs three times within the programme.
First-time participation is free of any charge.
Second-time and third-time participants are
charged for a part of the cost of participation
by CBI (see section on financial contribution
below). In the year following each
participation, the CBI will help you solidify and
expand your business contacts gained at the
trade fair. Throughout Phase 3, your
2
For more information about Medica: www.medica.de
company may also be actively involved in
other B2B activities carried out by CBI.
In practice, most of the above phases will be
overlapping, as the speed in which
participants proceed from one phase to the
other will be highly company-specific.
Financial contribution
The CBI is a development organisation
operating in a non-commercial market and
does not require participants in its
programmes to cover all costs. Participants in
an ECP do pay a non-refundable participation
fee of € 1000. The fee is collected as soon as
the CBI has determined that the company is
suitable for enrolment, at the end of phase 1.
Apart from this ‘registration fee’, companies
do not need to pay for CBI services.
International travel expenses incurred by
participants attending training in Europe may
be partially remunerated. If the CBI and/or its
partners arrange lodging, transportation and
meals, participants will not be charged. The
regular expenses made by the CBI and/or its
partners during the programme are not
charged to participants either. Participants
must cover other expenses not mentioned
here.
First-time trade fair exhibitors within the CBI’s
programmes are provided with a completely
furnished, free-of-charge stand in the CBI
pavilion. Second-time exhibitors are charged
for stand rent. Third-time exhibitors are
charged an additional 50% of the build-up
costs of the stand. This amounts to
approximately € 2000 for second-time
exhibitors and approximately €3000 for
participants that attend a third trade fair.
3
Export Coaching Programme for
Medical Devices and Laboratory Equipment
For successful EU market entry

Apply More information

Do you meet the ECP Selection Criteria? Send If you require more information or if you
in your application for the programme by have any other questions, you can
filling in the following 3 application forms contact the CBI:
attached to this document:
Jacoline Paul
Exporter’s Profile Logistical Manager
 for general company info E-mail: jpaul@cbi.eu
Export Audit Form Telephone: + 31 10 201 3411
 for more detailed info on your company
and management Lieke van Nierop
Supply Information Form Programme Manager
 for more detailed info on your products E-mail: lnierop@cbi.eu
and production processes Telephone: + 31 10 201 3437

Deadlines for application may vary per

country. For exact deadlines contact the
programme manager (see contact details
below). Filled-in forms have to be sent to CBI
by e-mail, fax or regular mail. Contact details
are mentioned at the bottom of the
application forms.

4
Export Coaching Programme for
Medical Devices and Laboratory Equipment
For successful EU market entry
Annex 1: List of possible products and corresponding HS-codes
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