How to be Eligible to Import Medical Devices in Ethiopia (from

regulation aspects)
Introduction
I have asked many colleagues and authorities what exactly the procedure of importing medical devices from
a recognized manufacturer to Ethiopia to make a business legal. As per the information gathered and
inferences from the documents, the mission of regulating medical devices and pharmaceutical products was
given to Ethiopian Food, Medicine, and Healthcare Administration and control authority (EFMHACA).
The EFMHACA was establish to safeguard the health and safety of patients, and other persons by ensuring
that manufacturers of medical devices follow specified procedures during the design, manufacture and
marketing as described in its proclamation No. 661/2009 for the regulation of medicines and healthcare
products. To become an agent or importer of any medical devices and products, there are some general
registration requirements set by Ethiopian Ministry of Health (MoH) and EFMHACA to become and
authorized importer and distributor (wholesaler) of pharmaceutical products. This authority has series of
procedures to permit to permit a company and its agent to import any device labeled as medical. In fact,
goods importation is a job and for that you need to have work license to do so from ministry of trade (MT)
before going for EFMHACA procedures. All things which are done by EFMHACA are device evaluation
from safety and performance aspects through registration, document evaluation, product inspection or
laboratory testing if needed. Therefore, the safer and better quality the device is, the more likely the importer
gets permission to import.

Figure 1: Flowchart of how to get Market Authorization Certificate to Import Medical Devices
General Registration Requirements for all Medical Devices (what the
registration dossier needs to include)
1. Application form
This is a form on which an applicant (usually manufacturer) who is requesting for the product’s
registration fills all necessary information some of which are: manufacturer’s name and address,
local agent’s name and address, description, intended use, shelf life and classification of the
product, list of attached files. At the end, it must be signed and stamped by the applicant.
2. Agency agreement
This is an agreement made by and between the actual manufacturer/supplier and the local agent.
It must be valid for at least one year from the time of submission, signed and stamped by the two
parties. For the purpose of administration, the agreement should remain valid for the period of one
year from the date of submission to the Authority, unless it is found to be satisfactory for the
termination of the agreement. The agent representing the manufacturer for importation should hold
a license issued by the ministry of trade and certificate of competence (COC) issued by the
Authority at the time of importation of the product. The agreement should specify the first agent
to handle the medical device registration process. In case the manufacturer wishes to have more
than one distributor, this must be mentioned in the agreement; but the maximum number of
distributors is limited to three.
3. Declaration of Conformity
This is the conformity declaration made by the actual manufacturer of the product stating that it
conforms to the essential requirements of medical devices safety and performance of the guideline.
4. Certificate of compliance with recognized standards
These are certificates issued by competent certifying bodies for complying with recognized
standards (eg. ISO, EC, etc.) And a free sale certificate issued by a competent national medical
devices regulatory authority stating that the product is freely sold in the country of origin and the
authority has no objection of exporting it. It must be valid and authenticated by Ethiopian embassy
in that country.
5. Manufacturer name and quality management
This includes manufacturer’s detail information, quality control and general quality management
system of source and authorization of raw materials, component handling, packaging, release,
recall procedures, and handling of compliance and out of specifications.
 6. Medical device essential safety and performance requirements
All medical devices, irrespective of their class, should meet the essential requirements of medical
device safety and performance principles as described in the guideline.
7. Manufacturing and production
This is the detail information of manufacturing processes from its design to packaging.
8. Labeling of medical devices
This refers to the guideline to know the type of information which need to be included on the
labeling of medical devices.
9. Sample of actual product
In some cases, sample of an actual product may be requested to be provided. This is when the
medical device is suspected to be defiant or needed for laboratory test.
In general medical device import requirement to Ethiopia includes documentation and other
requirements for both the U.S. exporter and foreign importer and requires:
 Agency Agreement  Insurance certificate
 A bank permit  Packing list
 A bill of landing or airway bill  Tax identification number (TIN)
 Certificate of origin certificate
 Commercial invoices  Value added tax (VAT) certificate
 Custom import declaration  Pre-shipment inspection clean report
 Foreign exchange authorization of finding
 Import license  Transit document

In medical device industry, the sale of laboratory analyzers like Hematology machine, clinical
chemistry machine and other ancillary devices (mostly used as supportive devices in research lab,
public hospitals and private laboratories) are the most important in terms of income generation.
From my long term experiences, the importing of the above devices is the most advantageous
one as once you sold them to the hospitals or private clinics, you will buy their reagent and spare
parts from manufacturers (with minimum cost), ship the product free of cost and sale them
frequently according to the warranty and agreements made with customers (hospitals and
clinics). In public health laboratory set up, the federal ministry of health (MoH) will take the
mandate to supply all laboratory devices and always face a challenge of supplying those devices
with their respective reagents and spares at the required time. Most of the laboratory devices
supplied by the government lack after sale services and stay idle for several months to years due
to logistic problem and bureaucracy in the government supply and purchase system. Since most
of devices are from China, their performance in daily usage is poor and lack preference from the
government. The most companies that government work with to import those devices are from
Abbot Diagnostic Gmbh, Sysmex Company, Beckton Dickinson (BD) Company and other China
manufacturers like Mindray and Dirui. Some of the laboratory devices with their respective
companies available currently in Ethiopia are listed in the following table:

Hematology Analyzers
No Equipment Manufacturer/Agent Country WBC Estimated Status
Name differential cost
1 Rubby Abbot/Subsaharan plc USA 5diff N/A Brand
New
2 Emerald Abbot/Sub-saharan plc USA 5diff/3diff N/A Brand
New
3 Cell Dyn Abbot/Afro German plc USA 3diff N/A Phased out
1800
4 Horiba ABX/Setema plc France 5diff/3diff N/A Under
warranty
5 BC-5150 Mindray/Afro German & China 3diff/5diff >400,000 Under
ZAF plc warranty
6 BC-3000Plus Mindray/Afro German China 5diff >400,000 Under
plc warranty
7 BC-5800 Mindray/Afro German China 5diff. 600,000 Under
Plc warranty
8 BCC-3600 Dirui/Pharmashare Plc China 3diff. >240,000 Under
warranty
9 BF-6500 Dirui/Pharmashare Plc China 3diff/5diff. >300,000 Under
warranty
10 Sysmex Sysmex/Pyramid Pharma Japan 5diff. N/A Under
KX21 Plc warranty
11 BC-5000 Mindray/Afro German China 5diff. N/A Under
Plc Warranty

Clinical Chemistry Analyzer

1 BS-200E Mindray/Afro German China Fully N/A Out of
Plc Automated warranty
2 BS-200 Mindray/Afro German China Fully N/A Out of
Plc Automated warranty
3 DR-777 Dirui/Pharmashare Plc China Semi- >90,000 New
automated
4 CS-T240 Dirui/Pharmashare Plc China Fully- >600,000 New
automated
5 A25 Biosystema/Agmas Plc France Fully- N/A
Analyzer automated
6 5010 Pharmashare N/A Semi- N/A Phased out
Photometer automated
Table 1: Laboratory devices supplied with their respective reagents and spares

Note: 3diff = 3 differential and 5diff. = 5 differential of WBC in blood

The equipments listed above are currently available in Ethiopia with most of them are gone out of
warranty and stop working. The government can’t supply the spare parts after the warranty has
expired because it is the challenge for the government to own the purchase of spare parts unless it
is supported by funding organizations and stakeholders. Most of the funding organizations are
from USA and other European countries and they will not cooperate to fund the government to
buy any spare from China. Instead, they will force the government to buy the devices from the
manufacturer in their country so that after sale of the device any service delivery like spare part
and reagent supply will be covered by those funding organization. Due to this most of the machines
imported from China by the government were remain idle across most of public hospitals.

The other devices currently available in Ethiopia are laboratory instruments for monitoring of TB,
HIV and other chronic diseases in Ethiopia. These instruments are directly supplied by the
manufacturing company themselves and have their own branches in Africa. For example Beckton
Dickinson Company has many branches in Africa, which one is branched in Ethiopia. The Roche
Company has its branch in South Africa and come to Ethiopia in time of failure for engineering
service until the warranty will expire.

No Machine name Company Country Function of the device Status

1 GeneXpert Cepheid USA MTB/RIF diagnosis New
brand
FACSPresto Beckton Holland CD4 Monitoring New
Dickinson Brand
2 (BD)
FACSCount Beckton Holland CD4 Monitoring Phased
Dickinson out
3 COBAS 411/6000 Roche Germany Clinical chemistry and Immuno New
chemistry testing brand
4 Biological Safety Baker USA A ventilated enclosure that New and
Cabinet (BSC) provides safety during sample old
extraction in the laboratory
Table 2: Laboratory Devices for TB, HIV and Immunochemistry diagnosis

Note: In the above table the device is manufactured in many countries like Japan, Canada, England, etc.

For the Device listed in number 4 above, it will be calibrated annually from certified engineer from
recognized company and the government pays more hundred thousand dollars a year. The most important
out of it is that there is no local representative in Ethiopia and mostly the manufacturer can supply the spare
part and charge service delivery. Thus if we work on it, I can prepare the required spares needed for devices
deployed across public hospitals in Ethiopia and go for it to discuss on how to own the whole work ahead
in the field. It is better to discuss whether we focus on the supply/importing of selected laboratory devices,
ancillary devices or other hospital equipment in the local market.

The importing of the following general hospital equipment are also very important in public and private
health sectors and most of agents in the local market do not have them all as required by customers.

No Name of equipment Requirement/Application area

1 Digital thermometer Hospitals (both private and public)
2 Suction Machine Hospitals (both private and public)
3 Radiant Warmer Hospitals (both private and public)
4 Autoclave Hospitals (both private and public)/Research lab
5 BP CAFF both digital and manual Hospitals (both private and public)
6 BP CAFF manual Hospitals (both private and public)
7 Compressor nebulizer Hospitals (both private and public)
8 Digital Weight measurement Hospitals (both private and public)
9 Examination light Hospitals (both private and public)
10 Gauge for Oxygen cylinder Hospitals (both private and public)
11 Ultrasound Hospitals (both private and public)
12 Incubator Hospitals (both private and public)
13 Neonatal pulse oximeter Hospitals (both private and public)
14 Adult pulse oximeter Hospitals (both private and public)
15 Wall thermometer Hospitals (both private and public)/Research lab
16 Weight scale Hospitals (both private and public)
17 Otoscope Hospitals (both private and public)
18 OR light Hospitals (both private and public)
19 Perfusor Hospitals (both private and public)
20 Oxygen Cylinder Hospitals (both private and public)
21 Laryngoscope adult Hospitals (both private and public)
22 Laryngoscope pediatric Hospitals (both private and public)
23 Centrifuge Hospitals (both private and public)/Research lab
Table 3: Hospital devices
Generally, I had prepared the above concept note from different inferences and information
gathering. If this note is enough, we will going to discuss on which device is preferable in the local
market. As per my experiences and observation the importing of laboratory analyzers in table 1
(clinical chemistry and hematology) and other devices listed in table 3 above are the most
preferable one. Hope we will look it together on device selection so that we will find way forward
to bring the thought assumptions to reality.