The article provides an overview of the regulatory requirements for medical device labeling introduced in Ethiopia.
The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the labeling requirements for medical devices intended to be marketed and used in the country. The document is intended to assist medical device manufacturers and other parties involved in achieving and sustaining compliance with the appropriate regulations, and also to ensure that all the important information related to the safety and performance of medical devices is duly communicated to healthcare professionals and patients by the virtue of labeling, including the labels themselves, as well as other documentation accompanying the device.
According to the applicable legislation, EFDA as a country’s regulatory agency is entitled to undertake supervision of the quality, safety, and effectiveness of medical devices placed on the market, while labeling plays an important role in ensuring the safety and proper performance of medical devices when they are used for the intended purpose. In this regard, the authority takes action to ensure that all the information provided in the labeling is accurate and is not misleading. As set forth by Article 53 of Food and Medicine Administration Proclamation 1112/2019; the medical devices to be marketed in the Country [should] be appropriately packed and contain labeling that is not misleading, and does not contain information that is inaccurate and should include a barcode. The present guidance is based on the provision of the said article and provides additional recommendations regarding the regulatory requirements set forth therein.
Labeling usually contains the information necessary to identify the product and its manufacturer, and also to ensure it could be used properly, safely, and efficiently. The said information could be placed directly on the product, on the packaging used to supply it, as well as in the documentation accompanying the device. The present document is intended to provide additional clarifications regarding the scope of information the labeling should contain, and also on the way such information should be provided.
Terms and Definitions
First of all, the document provides definitions of the most important terms and concepts used in the context of labeling requirements for medical devices including, inter alia, the following ones:
- Intended use – the objective intent of the manufacturer regarding the use of a device, process, or service as reflected in the specifications, instructions, and information provided by the manufacturer or the medical device.
- Labeling – the label, instructions for use, and any other information that is related to identification, technical description, intended purpose, and proper use of the medical device, but excluding shipping documents.
- Label – all labels and other written, printed, or graphic material that is affixed to a medical device or any of its container or wrapper and includes insert.
- Primary packing – the covering, wrapper, or container that has direct contact with the medical device.
- Secondary packing – the packing that covers the original (primary) packing of a medical device. It doesn’t come into direct contact with a medical device and would include a carton.
Apart from the ones mentioned hereinabove, the authority also provides the definitions of such terms as “accessory”, “layperson”, “instructions for use”, “refurbishment”, “research use only”, and “user”.
Scope and Objectives
The scope of the present guidance covers any medical devices intended to be marketed and used in Ethiopia, including the in vitro diagnostic (IVD) ones. It also covers spare parts and accessories intended to be used with these devices.
As it is stated by the EFDA, the document is intended to provide clarifications regarding the applicable regulatory requirements for the content of the label, instructions for use, and information to be duly communicated to ensure the device will be used safely and efficiently.
General Labeling Requirements
By the existing legislation, all the information contained in labeling should be provided in English and/or Amharic languages. The authority additionally emphasizes that labels should be legible, indelible, and not easily detachable. Moreover, all the information included in the labeling should be properly justified. It is also stated that the labeling should not contain any information that contradicts the applicable laws and regulatory requirements, nor should it contain any statements regarding the performance of the device that are contradicting the said regulatory requirements.
As further explained by the EFDA, the party responsible for the device should decide on the particular way to present the information depending on the product itself and its specific features, provided that the readability of information is ensured, and it contains all the necessary details that are mandatory under the applicable legislation. It is also stated that the information contained in the instructions for use should be provided in a way ensuring it is clear and understandable for the intended users of the device based on their expected skills and qualifications – should the device be intended to be used by laypersons without the appropriate background in the healthcare sphere, it is important to avoid the use of terminology that could not be interpreted properly by the potential users. In certain cases, it makes sense to provide information aimed at healthcare professionals and laypersons separately.
Apart from the above mentioned aspects, the labeling should contain information regarding the residual risks – the ones that remain upon implementation of risk mitigation measures intended to reduce the risks associated with the use of the device to an acceptable level.
At the same time, it is allowed to provide abbreviated instructions, or even supply devices without instructions for use, in case such devices are low-risk ones, or the way they should be used is obvious to the intended users, and the devices could be used safely and efficiently without additional information provided.
Depending on the nature of the product and other factors, labeling may be provided to the user in various media and by several means such as printed documents, through a display screen incorporated into the device, the manufacturer’s website, and magnetic or optical media. The authority also mentions that whatever the media or the means, information should be targeted to the anticipated user population.
In summary, the present EFDA guidance highlights the most important aspects to be considered about the regulatory requirements for medical device labeling implemented in the country. The document outlines the scope of information to be included in labeling and describes in detail the main principles to be followed.
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