Project document

CBI Export Coaching Programme

Medical Devices

1. Introduction
2. What is CBI?
3. Programme description
4. Selected countries
5. Selected products
6. Application procedures

Exporters Profile (EP)

Export Audit Form

Peter J. van Gilst

Project manager
1. Introduction

On the basis of the results achieved in previous programmes and on the basis of
expected market opportunities, CBI has decided to offer companies that
manufacture medical devices the possibility to join the present programme as
new participants. Only companies from the countries selected (see 4) and
manufacturing products as listed (see 5) are eligible for participation.

Companies that wish to participate are requested to read the project document
carefully and to send all requested information to CBI.

2. What is CBI?

CBI is the Centre for the Promotion of Imports from Developing

Countries, an agency of the Netherlands Ministry of Foreign Affairs.
Since its establishment in 1971 CBI has operated within the policy
framework set by the Minister for Development Cooperation. Its main
objective is to contribute to the economic independence of selected
developing countries by helping small and medium-sized enterprises
(SMEs) and trade promotion organisations (TPOs) to develop their
export capabilities and promote their exports of non-traditional goods
and services to the European Union (EU).

Export Coaching Programmes (ECP)

A step-by-step approach provides intensive support for selected
exporters in developing countries, so that they can secure a firm
footing on the EU market. Programmes are made to measure, demand-
driven and flexible, combined with fixed elements such as:
- pre-selection of candidates based on written documentation;
- technical assistance during company visits and distance
guidance by CBI branch experts;
- export marketing training (for instance through the EXPRO
seminars);
- market entry (for instance via participation in European trade
fairs);
- market consolidation by way of follow-up support, further
technical assistance and/or repeat market entry activities.

3. Programme description

Objectives
To assist companies in obtaining a firm and lasting position on the EU market.

Depending on the needs and requirements, selected companies may receive

support in the field of product improvement, production, quality control,
compliance to EU standards and regulations, management, export marketing and
market entry.

Financial conditions
All CBI services and programmes, including this Export Coaching Programme, are
sponsored by the Netherlands' Government and are as such free of charge. In
other words, interested exporters will not be charged by CBI for any of the
services offered.
However, interested companies should be aware of the fact that certain expenses
will not be covered by CBI such as e.g. the sending of information and, if
requested, samples; arranging for local transport during a possible visit by a CBI
product consultant to your company; cost for ticket, accommodation etc. when it
comes to participation in phase 4, the international trade fair in Düsseldorf,
Germany. Apart from these expenses, costs for product adaptation,
improvements in production, marketing etc., may be required.

The ECP’s are targeted at companies in developing countries that have the
capacity (or potential) to export to the EU.

Company criteria
The following criteria apply for participating companies:
• The ownership of the company (at least 51%) is held by local people, or by
(co-) owners who reside in another developing country (excluding developing
countries characterized as UMIC1 or higher);
• The company is not a joint-venture with, or does not have as a parent
company, a company that resides in a country characterized as UMIC or
higher;
• The number of employees is between 25 and 500;
• The company is not bound by licence agreements that limit the export
possibilities to the EU;
• The management of the company is able to communicate in the English
language;
• The company is willing and able to invest in adaptations of the product
assortment and production process if the international market conditions
require;
• The company has been audited by CBI on a number of export success criteria
(a.o. export experience, product development, quality management,
awareness of environmental and social issues, availability and use of
resources, attitude towards export and knowledge and skills of the
employees) and the overall outcome is positive.
•

Description of the various phases of the programme

Phase 1. Pre-selection
Based on extensive information provided by interested manufacturers/ exporters,
an independent CBI product consultant will make a pre-selection of companies
with anticipated chances to enter the European market.

Phase 2. Identification and technical assistance

Participants selected on the basis of their performance in the previous phase, will
be visited by the CBI product consultant in order to:
- judge the suitability of the companies visited in terms of, among other
issues, production facilities and capacity, product properties, international
competitiveness, quality control, organisation of production and export
function, management etc.;
- provide technical assistance and advice in all relevant fields including
marketing, management, production, quality control, product adaptation to

1
Upper Middle Income Countries, see World Bank for definition of the various categories.
 European market requirements regarding product, price, packaging, non-
tariff barriers such as CE marking, environmental and social issues incl.
labour conditions, etc.

The duration of the consultant’s visit will on average be two days.

At the end of the visit, an action plan will be compiled, consisting of a description
of the main problems, corrective actions to be taken and deadlines before which
the problems have to be solved. With respect to implementing the plan of action,
CBI will provide monitoring and advisory services.

Phase 3. Export marketing training

The only companies selected are those which:
- are found to be suitable on the basis of the expert’s findings during the
company visit;
- demonstrate their motivation and serious intentions by actively
implementing the required improvements as described and agreed upon in
the action plan.

A one-week export marketing seminar, called EXPRO, is held in Rotterdam, The

Netherlands. Relevant export marketing and management subjects as well as
more product related subjects will be covered through lectures, cases and
assignments. Field visits as well as individual counselling sessions between the
CBI product consultant and the participants, discussing the progress of the
implementation of the action plan, are also part of the programme.

The main objective of this seminar is to further prepare the participants for
entering and dealing with the European market.

Phase 4. Market entry

CBI supported participation - for strictly selected companies - in the international
trade fair on medical devices, the MEDICA in Düsseldorf, Germany.

The objectives are:

- to establish personal contacts with potential business partners in Europe;
- to gather further information on the European market.

What does CBI offer to selected companies?

- a pre-fair briefing giving latest market information and advice on trade fair
behaviour;
- pre-fair publicity and invitations to buyers through mailing and
telemarketing;
- stand space and a fully equipped stand of around 12 sqm;
- assistance with stand decoration;
- advisory services during the trade fair by the CBI product consultant, for
instance on trade partner selection and matchmaking.

Phase 5. Market consolidation

Turning business contacts, established at the fair, into durable business relations,
often requires a major effort by the participants after the fair. CBI will be
instrumental in this process as much as possible, by giving follow-up support
and/or further technical assistance.
As exporting is a long-term business, a one-time trade fair participation is often
not sufficient to establish a firm and lasting foothold on the European market.
Selected companies might be invited to participate for a second time, with CBI
support, in the trade fair MEDICA. The companies in question will, in that case,
have to cover a bigger share of the cost incurred.

4. Selected countries

Manufacturers of medical devices from the following countries are eligible for
participation:

Egypt, India, Indonesia, Jordan, South Africa, Thailand, Tunisia

5. Selected products

Main categories.
1. Surgical (indanthrene) linen and/or non woven for doctors' and/or patient
use to be used in the operating theatre and/or out-patient
department;
2. Bandages, gauzes, swabs made of cotton and/or non woven and adhesive
plasters of any type and description, sterile and unsterile packed,
infant and adult non woven underpads and diapers for incontinence
purposes;
3. Urinary and prophylactic condoms, latex surgical and examination gloves,
polythylene and/or copolymer examination gloves;
4. Medical devices to inject or aspirate blood or other fluids (e.g. medication)
including blood infusion and/or transfusion and/or administration
systems, and blood sampling products;
5. Catheters and medical tubing including suction devices drainage systems
and associated products, made of various materials;
6. Diagnostic devices such as reagents, blood sampling needles, blood
pressure metres and stethoscopes (electronic and conventionel),
petri dishes with or without culture media, etc.;
7. Laboratory devices, tubing and equipment (e.g. microscopes) pertaining to
medical and biological analyses;
8. Devices for CSSD's, such as packaging material, biological and non-
biological sterility indicators as well as sterility test devices and
associated products. Also included are disinfection products;
9. Surgical stainless steel instruments and devices;
10. General nursing patient care products and devices;
11. Instruments and/or devices for chiropody;
12. Instruments and/or devices and/or equipment for:
anaesthesiology, cardiology, cardiopulmonary surgery, surgery
(general), dermatology, internal medicine, opthalmology, ear-nose-
throat (ENT), paediatrics, paediatric surgery, clinical-chemistry,
pathology, lung-diseases, gastro-enterology, medical-microbiology,
neuro-surgery, nuclear medical science, orthopedic surgery,
corrective or plastic surgery, proctology, radio diagnostics,
radiology, radio therapy, physical rehabilitation medical science,
rheumatology, urology, obstetrics and gynaecology, dental and
mandibulary surgery/maxilary surgery, orthodontics, mouth
diseases, sport medical science.
Excluded are:
- pharmaceutical products and veterinary products

6. Application procedures

The step by step approach as described above, implies that interested and
suitable companies can only enter the programme by applying for phase 1, the
first step in the programme. Participation in each following phase will depend on
the performance in the preceding phase.

How to participate in phase 1 (Pre-selection)

Suitable manufacturers/exporters should send the following information to reach
CBI:

- completed CBI-Exporters Profile and annexes (the forms are attached to

this project document);
- your trade offer with FOB and CIF prices in US$ or Euro’s, with terms and
conditions, including delivery times, minimum order and shipping quantity
etc.
- available company documentation: organisation chart, annual report,
catalogue, brochure, photographs of your products, product data sheets,
video (VHS/PAL);
- detailed product specifications e.g. materials used, dyes used, standards,
dimensions/sizes, packaging (materials used, inner and outer packaging),
applications, etc.;
- a description of your quality control system; indicate whether or not you
have experience with international standards such as GMP, ISO 9000
and/or EN 46000 series; if available send us copies of any possible
certificates of ISO, CE etc.

Please note that only complete applications fulfilling the above requirements
will be processed.

Addresses for sending your application for phase 1:

By Mail : CBI
ECP Medical Devices
P.O. Box 30.009
3001 DA ROTTERDAM
The Netherlands

By Courier : CBI
ECP Medical Devices
Beursgebouw, 5th floor
Beursplein 37
3011 AA ROTTERDAM
The Netherlands

By Fax : +31-10-4114081

By e-mail : cbi@cbi.eu
CBI Project manager : Mr. Peter J. van Gilst