EFDA Guidelines on Low-Risk Medical Devices

Regulatory Background

According to the applicable legislation, any and all medical devices intended to be marketed in Ethiopia should be subject to preliminary assessment and state registration. The regulatory requirements for registration depend on the type of medical device in question and the risks associated thereto.

 In accordance with the Ethiopian risk-based classification, all medical devices are divided into four classes, namely:

1. General medical devices – Classes I to IV,

2. In vitro diagnostic medical devices – Classes A to D.

The EFDA states that Class I and Class A medical devices, as the products with the lowest potential risk, could be placed on the market provided they are compliant with the minimum safety and effectiveness requirements in order to reduce the unneeded regulatory burden and expand their availability for healthcare professionals and patients. In particular, in the case of low-risk medical devices, a notification procedure could be applied. However, the authority additionally emphasizes that sterile medical devices, as well as devices with measuring functions, are not eligible for an exemption described herein. Hence, the approach described in the present EFDA guidelines applies only to general Class I/A medical devices. 

The document is intended to provide medical device manufacturers and other parties involved with additional clarifications and recommendations with regard to regulatory requirements related to low-risk medical devices, and also on the procedures to be followed in order to place them on the country’s market. 

First, the guidelines provide the definitions of the most important concepts used in the context of low-risk medical devices and the regulatory framework associated thereto. 

• Abbreviated assessment stands for medical device marketing authorization application assessment procedure that focuses on verifying completeness and authenticity of administrative documents with few or no technical requirements. 
• Medical device Category is the broadest level of Medical devices categorization which divides the entire medical device product market into highest-level groups based on device application, technology, or other characteristics. 
• Measuring devices covers devices whose intended purpose implies accuracy, claimed explicitly or implicitly, where non-compliance with the implied accuracy could result in a significant adverse effect on the patient`s health and safety. 

Low-Risk Medical Device Inclusion Criteria

• It should comply with the applicable manufacturing and quality control standards.
• The risks associated with the use of the device for its intended purpose should be low.

Special Requirements

• Details of the manufacturer, including its name, trademark, and business addresses. It is also allowed to include information about an authorized representative, but it should be provided in a way excluding confusion.
• Country of origin.
• Indication of the type of medical device and its intended use.
• A diagram showing the components of the device and the way they are placed inside the package.
• Lot number.
• The date when the device could be used.
• Indications on storage and transportation.
• Unique identification/device code.
• Bar code.
• CE mark (if applicable).

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Sources:

http://www.fmhaca.gov.et/wp-content/uploads/2021/04/Guideline-for-Marketing-Authorization-of-Low-risk-Medical-devices_EFDA.pdf