The first article provides an overview of importation requirements and outlines the main principles thereof.
Table of Contents
The Ethiopian Food and Drug Authority (EFDA), a country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the requirements of medical devices clearance and ports of entry. The document intended to provide additional clarifications regarding the applicable regulatory requirements to be followed by medical device importers, as well as recommendations to be considered to achieve and sustain compliance thereto. The present document published in January 2022 constitutes the initial version of the guidance.
Regulatory Background
First of all, the EFDA provides a brief overview of the applicable medical device classification system and emphasizes that specific requirements the device would be subject to should be determined depending on the respective class under the risk-based classification. In particular, this applies to the inspection at the port of entry and the scope of documents to be submitted in the course of importation.
The authority also mentions that when developing the present guidance, it has also considered the relevant recommendations issued by international organizations, such as the European Commission, Global Harmonization Task Force (GHTF), United States Food and Drug Administration (USFDA), and World Health Organization (WHO).
The document provides additional details regarding the requirements related to the importation of medical devices. Its scope covers such aspects as labeling requirements, a procedure for importation of medical devices, and the required documents (administrative and technical documents) in support of the port clearance of medical devices. Apart from this, the document also highlights the main points related to the inspection and port clearance procedures to be applied depending on the class of the device in question. The authority also mentions that recommendations provided herein should be followed irrespectively for the importation purpose.
As explained by the EFDA, the guidance is intended to:
- Provide additional recommendations to be considered by all the parties involved in operations with medical devices;
- Assist the authority’s staff when performing their obligations for clearance procedures; and
- Introduce efficient measures preventing the importation of non-compliant medical devices.
The scope of the guidance covers all medical devices intended to be marketed and used in Ethiopia including both general and in vitro diagnostic ones.
Key Terms
To assist importers and other parties involved with interpreting and following the applicable regulatory requirements, the EFDA provides definitions of the most important terms and concepts used in the context of the guidance. These definitions include, inter alia, the following ones:
Accessory – a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. As further explained by the EFDA, accessories are initially intended to be used with a particular device.
Import permit – a permit issued to importer/institution/recipient by the Authority, authorizing him to import medical devices into the country.
Port clearance – is official permission to bring medical devices into the country (Ethiopia) for sales or distribution for use.
Apart from the ones listed hereinabove, the guidance also provides definitions of such terms as “Authority”, “Consignment”, “Donation”, “Recipient”, and “Spare part”.
Medical Devices Importation
According to the guidance, the parties that could be involved in importing medical devices include:
- a) Medical Devices Importers;
- b) Government and Non- Governmental Health institutions;
- c) Clinical Trial Investigators;
- d) Health Research Institutions;
- e) Recipients of donations;
- f) Persons importing medical devices for medical purposes;
- g) Exhibitors.
The document further describes the applicable regulatory requirements in the sphere of importation of medical devices. Under the general rule, any medical devices subject to importing should be registered by the authority. Moreover, an importation should be carried out by the licensed importers, and all the premises used should be registered as well. To be allowed to import medical devices, an entity should have the relevant pre-approved purchase order (PO) or pre-import permit, while the devices should be imported only through points of entry.
Specific rules should be also applied in case of donation – the appropriate permission should be received by an interested party, and such devices cannot be received before the aforementioned approval will be duly received. The authority additionally emphasizes that medical devices originating from unknown sources cannot be donated. It is also important to mention that equipment that has been used for more than 5 years cannot be donated.
In the case of medical devices imported to be used in clinical trials, such trials should be approved by the respective department beforehand.
Packaging and Labeling
Existing legislation also sets forth the requirements to be followed in terms of labeling and packaging for imported medical devices.
The packaging used should be appropriate concerning the nature of the devices being transported and their specific features. In particular, the packaging should protect efficiently from the adverse impact that could be caused by external factors. Apart from this, the packaging of [a] medical device should also indicate the direction [of] the package and the maximum number of packages stacked above each other.
According to the applicable requirements on labeling, information about the device should be provided in English and/or Amharic in a way prescribed by the respective Guideline on Labeling Requirements of Medical Device Labeling issued previously by the authority. The labels themselves should be placed in a way ensuring they would not be accidentally detached, and all the information contained therein should be visible and understandable for the users. The EFDA emphasizes that any information included in labeling should be duly justified. The scope of information to be included in labeling is also provided in the guidance. The authority also mentions that for certain medical devices (e.g., active, implantable, or radiation-emitting ones) special requirements should be applied – for instance, the appropriate warnings should be placed on the label. The requirements for other elements of labeling, such as instructions for use, service manuals, and other documentation accompanying the device should be determined depending on the class of the device under the risk-based classification. To ensure correct interpretation, internationally accepted symbols should be used to provide additional information.
It is also important to mention that medical devices intended for investigational purposes are exempted from the general labeling requirements described herein. If such products are imported for additional laboratory research, their labeling should contain a statement: “For Research Use Only. Not for use in diagnostic procedures”.
In summary, the present guidance highlights the main principles to be considered for importing medical devices in Ethiopia. The authority also provides additional clarifications regarding the applicability of general requirements in the context of importing and clearance.
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