Ethiopian Food, Medicine and Healthcare Administration and Control

Authority

Medical Equipment Donation Directive

December 2012

Addis Ababa

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Contents
Contents ............................................................................................................................................................... II

Part One ............................................................................................................................................................... 1

General ................................................................................................................................................................. 1

1. Short Title .................................................................................................................................................... 1

2. Definitions.................................................................................................................................................... 1

3. Objective ...................................................................................................................................................... 1

4. Scope of Application ................................................................................................................................... 2

5. Principle ....................................................................................................................................................... 2

Part Two ............................................................................................................................................................... 2

Requirements for Donation ................................................................................................................................ 2

6. General Requirements ................................................................................................................................ 2

7. Pre-import Permit ....................................................................................................................................... 3

8. Requirement at Port of Entry ..................................................................................................................... 3

9. Post entry Requirements ............................................................................................................................ 6

10. Rejection of Donation ............................................................................................................................. 6

Part Three............................................................................................................................................................. 6

Miscellaneous Provisions .................................................................................................................................... 6

11. Reporting ................................................................................................................................................. 6

12. Disposal.................................................................................................................................................... 7

13. Inapplicable Laws .................................................................................................................................... 7

14. Effective Date .......................................................................................................................................... 7

Annex I.................................................................................................................................................................. 8

Annex II...............................................................................................................................................................10

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Preamble

WHEREAS, medical equipment has significant contribution to the improvement of quality

healthcare service;

WHEREAS, it is found necessary to protect the community from unsafe, incompatible, non
functional, substandard and outdated medical equipment by ensuring the safety, usability and
quality of donated medical equipment and make sure they have the necessary installation or
service manual, spare parts and continuity of maintenance;

WHEREAS, it is found necessary that medical equipment donation must be based on sound
analysis of the need of recipients and the selection and distribution shall observe existing policies
and laws of the country;

NOW, THEREFORE, with a view to rectify the existing donation practice; this directive is
issued in accordance with Article 55 (3) of the Food, Medicine and Healthcare Administration
and Control Proclamation No.661/2009.

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 Part One

General

1. Short Title

336/2020
This directive may be cited as the “Medical Equipment Donation Directive No. 9/2012”

2. Definitions

Without prejudice to the definitions provided under Proclamation No 661/2009, in this

directive, unless the context otherwise requires;

1. “Medical equipment” means any instrument that may be used on the inner or outer part
of the body for diagnosis or treatment of a disease in human. This includes various
diagnostic, laboratory, surgery and dental medical instruments;
2. “Donation” means an act or instance of presenting medical equipment to recipients in
emergency or as a part of development aid in non emergency situation;
3. “Donor” means a governmental or nongovernmental organization or individual who
voluntarily donates medical equipment as a donation;
4. “Recipient” means a governmental, non-governmental or private health institution that
voluntarily receives medical equipment as a donation;
5. “Authority” means the Ethiopian Food, Medicine and Healthcare Administration and
Control Authority

3. Objective

The objective of this directive shall be:-

1. to protect and promote the health of the community by ensuring the safety, usability
and quality of donated medical equipment;
2. to alleviate problems associated with donation by promoting good medical equipment
donation practice;
3. to make sure donated equipments are in compliance with the need of the country;
4. to provide rights and responsibilities of the donor and recipient; and
5. to control importation of unwanted medical equipment as well as minimize the
accumulation of non-functional medical equipment.

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4. Scope of Application

This directive shall be applicable to all donated medical equipments.

5. Principle

1. Donation shall be in accordance with the recipient’s need and comply with the
existing government health policies, laws, guidelines and administrative
arrangements.

2. Donation shall comply with applicable standards and there shall be no double
standards regarding quality of donated items. Equipment unacceptable in the donor
country shall not be accepted.

3. Donation shall support and enable recipients to promote the quality of health services.

Part Two

Requirements for Donation

6. General Requirements

1. No medical equipment shall enter in to the country without prior permission of the
Authority.
2. Recipient shall not receive and import medical equipment donation without the prior
approval of the Authority.
3. No medical equipment shall be donated if it was collected from unknown source, sent
without prior communication between the recipients and donors or given to health
professionals as free samples.
4. If the equipment is used it shall be reconditioned, tested and all essential parts,
accessories and working materials included before shipment.
5. No medical equipment may be donated if the equipment has been in use for more than
five years.

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7. Pre-import Permit

1. Anyone who wants to import or receive medical equipment as a donation shall have a
pre-import permit from the Authority.
2. Any person who seeks pre-import permit shall submit an application in 4 duplicates to
the Authority in accordance with the provided Annexes.
3. The applicant, together with the application, shall submit:
a. an agreement entered into between the donor and recipient;
b. certificate of competence of the recipient;

c. a declaration that for electrical equipment, the electrical needs of the equipment will
be set to the standard voltage of 240V/50Hz and for X-ray emitting equipment that it
will be calibrated and inspected by a qualified Medical Physicist prior to shipment;
d. support letter from Federal Ministry of Health or Regional/City Administration
Health Bureaus as appropriate; and
e. Performa invoice, where applicable
4. The agreement referred under sub-article (3) (a) of this article shall includes the aim,
source, beneficiary and location of beneficiary, amount, support and maintenance
mechanism, sufficiency of spare parts and consumable items, responsible body, and
monitoring and evaluation mechanism of the donation.
5. The letter mentioned under sub-article (3) (d) of this article shall clearly state if the
issuing organization support the donation, and mention or attach the type and amount of
the intended donation.
6. The Authority shall give pre-import permit when the application fulfills the requirement
provided under this directive. If the Authority rejects the application, it shall inform the
applicant in writing by stating the reason for denial.
7. Unless renewed by the Authority, pre-import permit issued in accordance with this
article shall be valid for only nine months.
8. While granting pre-import permit the Authority shall consider if the equipment is
compatible with the level of the recipient.

8. Requirement at Port of Entry

1. Donated medical equipments shall have port clearance from the Authority before
custom clearance.
2. Donated medical equipment at port of entry shall be accompanied by the following
documentary evidences:

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 a. valid pre-import permit;
b. donation certificate;
c. certificate of origin;
d. packing list;
e. commercial invoice, if applicable;
f. airway bill or bill of lading;
g. certificate of refurbishment for used equipment and
h. certificate of analysis for sterile medical equipment;

3. The certificate of refurbishment mentioned under sub-article (2) (g) of this article shall be
issued by the manufacturer or certified company and shall state if the equipment is

a. tested, labeled and packed; and

b. replaced or repaired and the repair service that were performed on the equipment,
and the source of the repair parts and provide an acceptance report for these parts;
c. calibrated it shall state and verify the operation of the equipment and the
performance standard used to calibrate it; and
d. disinfected or decontaminated.

4. Donated medical equipment shall:

a. if applicable, be robust and fully operational as a full system or as a separate
subsystem;
b. meet or exceed existing safety and performance specifications provided by the
manufacturer, international or appropriate national organ;
c. include all essential parts, accessories and working materials;
d. have its label, user manual and other documents written in English or Amharic;
and
e. be packed suitable for road, air or sea transport under tropical conditions.

5. For software operated equipment, the software shall be either preloaded and/or
accompanied by the software package.
6. For electrical equipment, the electrical needs of the equipment shall be set to the standard
voltage of 240V/50Hz and for X-ray emitting equipment that it shall be calibrated and inspected
by a qualified Medical Physicist.

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7. Damaged, outmoded, and redundant equipment for which spare parts and consumables are
no longer available and/or equipment which is no longer supported by the manufacturer
shall not be accepted.

8. Depending on its nature and type, the label of donated medical equipment shall at least
include:
a. the name of the medical equipment;
b. model number or serial number;
c. manufacturing date;
d. life span or expectancy;
e. name and address of the manufacturer;
f. handling and storage requirement;
g. technical direction for use;
h. an indication, if applicable, that the medical equipment is intended to be used only
for clinical or performance investigations before being supplied;
i. for a sterile medical equipment, the word “Sterile” and where appropriate,
description of methods of re-sterilization;
j. if the device is a refurbished, an indication of the device as refurbished device;
k. if the device is intended for presentation or demonstration purposes only, it must
be labeled as “for presentation or demonstration purposes only, not for use on
human”;
l. if the device emits radiation for medical purpose, details of its nature, type and
where appropriate, the intensity and distribution of this radiation;
m. if the device is to be installed with or connected to other medical device or
equipment, or with dedicated software, in order to operate as required for its
intended use, sufficient details of its characteristics to identify the correct device or
equipment to use in order to obtain a safe combination;
n. if the device is an in vitro diagnostic medical device it must be labeled as “ in
vitro diagnostic” or “IVD”;
o. the intended purpose of the medical equipment, the intended user of the medical
equipment, and the kind of patient on whom the medical equipment is intended to
be used (if this information is not obvious).
9. The format, content and location of the information described under sub-article (4) of this
article shall be appropriate for the medical equipment and its intended purpose.
10. Any number, letter or symbol, and any letter or number in a symbol, used in the label
shall be legible.
11. Each donated medical equipments shall have accompanying user manual having detailed
information on handling, installation, operation, maintenance, trouble shooting,
precautions and other important information.
12. Donated medical equipment shall be transported, stored and handled in accordance with
acceptable transportation, storage and handling requirements.

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13. The location of labeling information provided under sub-article (4) of this article shall:
a. Unless it is impracticable or inappropriate to do so, the information required to be
provided with medical equipment shall be provided on the medical equipment itself.
b. If it is not practicable to comply with sub-article (13) (a) in relation to the provision
of the information, the information shall be provided on the packaging used for the
medical equipment, or in the case of medical equipment that are packaged together
because individual packaging of the medical equipment for supply is not
practicable, on the outer packaging used for the medical equipment.
c. If it is not practicable to comply with sub-article 13 (a) or (b) in relation to the
provision of the information required, the information shall be provided on an insert
supplied with the medical equipment.
d. If it is not practicable to comply with sub-article 13 (a), (b) or (c) the information
shall be provided in a printed document or using other appropriate media.

9. Post entry Requirements

Donated medical equipments entered into the country in accordance with the above
provisions shall be transported, stored, handled, distributed and used in accordance with
applicable laws and standards of the Authority.

10. Rejection of Donation

Any donation which does not comply with the requirements prescribed under this
directive shall be rejected.

Part Three

Miscellaneous Provisions

11. Reporting

The recipient shall report relevant information to the Authority including defects, adverse
effect, problems related to quality and safety and other reportable cases related to the
donated equipment.

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12. Disposal

If donated medical equipments are found to be violative, the recipient shall dispose or
return the product to the country of origin on its own expense.

13. Inapplicable Laws

No directive or practice shall, in so far as it is inconsistent with this directive, be

applicable with respect to matters covered by this directive.

14. Effective Date

This directive shall enter into force on 13 August 2012.

Yehulu Denekew

Director General

Ethiopian Food, Medicine and Healthcare Administration and Control Authority

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 Ethiopian Food, Medicine and Healthcare Administration and Control Authority

Annex I
Application Form

Medical Equipment Donation Request Form

1. Name of the applicant …………………………………….

2. Type of institution
a. Governmental
b. Non governmental
c. Private
3. Address of the institution
Region …………. city…………. …sub city………. woreda………………
kebele…… ………email………….Tel …………….
4. Person in charge of the application
a. Name ………………………..
b. Qualification…………………
c. Responsibility………………..
5. Intended purpose of donation
a. Emergency
b. Development aid program
c. Other
6. Recipient for donation
a. Name ………………….
b. Address
Region …………. city…………. …sub city………. woreda………………
Kebele…… ………e-mail………….Tel …………….
c. Responsible person

Name…………….…………….. Responsibility……………………………..

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 7. Description of medical equipments

Item Description of the Medical Unit Quantity Unit Total Price

No. Equipment* Price**

* Description shall include Name, Brand, Batch or Model Number, Manufacture’s Name, Date
& Address, life span or expiry date, label language
** If the medical equipment is not a brand new, please specify estimated or book value.

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 Ethiopian Food, Medicine and Healthcare Administration and Control Authority

Annex II
Pre-Import Permit for Donated Medical Equipment

Date…………….
Ref. No…………...

Name and address of recipient Name and address of donor

___________________________ ___________________________

___________________________ ___________________________

___________________________ ___________________________

___________________________ ___________________________

The permission is granted to import the following medical equipments as per the Medical
Equipment Donation Directive No. 8/2012 of the Authority

S.No Item Manufacturer Country Unit Quantity Unit Total

Description Price price

Mode of transportation___________________________

Port of arrival ___________________________

This pre-import permit is valid only for none months from the date of its issuance
Upon arrival the consignment is subject to inspection to get import permit clearance

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