EFDA Guidelines on Low-Risk Medical Devices

Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority in the sphere of healthcare products, has published guidelines dedicated to the regulatory procedures for placing low-risk medical devices on the market. The document constitutes the initial version of the guidance.

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

The new guidance published by the EFDA describes in detail the particular criteria to be applied in order to determine whether the medical device in question falls within the scope of the definition of a low-risk medical device and thus could be placed on the market under the simplified procedure. As mentioned, the general rule prescribes that all Class I/A medical devices, apart from sterile and ones with measuring functions, could be placed on the market through a notification pathway. However, the device subject to review should also meet the following 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.

The authority also mentions that in case the medical device in question is not included in the list of products eligible for placement on the market under the simplified procedure for low-risk devices, but its manufacturer reasonably deems the device meets applicable criteria, it is allowed to apply for inclusion in such a list.

Special Requirements

The document further describes the specific requirements to be applied for low-risk medical devices eligible for placement on the market under the notification pathway. According to the guidance, in the case of such devices, the interested party is not obliged to submit a complete dossier. The usual conformity assessment procedure should not be applied as well. The only documents required are the administrative form and confirmation of payment for the service fee. However, in certain cases, it could also be necessary to submit technical documentation related to the medical device in question in order to demonstrate compliance with the regulatory requirements set forth by the applicable laws and standards.

The complete set of document to be submitted by the applicant company includes the following:

1. Application form dated and signed by an authorized representative of a company. A form shall contain the name of the medical device subject to review.

2. List of devices covered by the scope of application, together with additional information about them (e.g. generic and brand names, model, intended use, class under the risk-based classification, etc.).

3. Authorization letter and agency agreement – in case of the application submitted not by the manufacturer itself, but by its authorized representative. This applies in the case of foreign manufacturers.

4. Marketing authorization status in other countries. The applicant shall also provide a list of countries in which the medical device in question is allowed to be marketed and used. Additionally, it is necessary to provide details about all changes to the regulatory status of the product, including withdrawals. The applicant shall provide exhaustive information about the marketing history of the product and approvals granted by foreign national regulating authorities in the sphere of medical devices.

5. Product information, including packaging and labeling. The applicant shall also submit the samples of the package insert and labeling in order to demonstrate their conformity with the Ethiopian requirements for medical device labeling. The information contained in labeling should be provided in English or Arabic and should also meet the claims made by the manufacturer with regard to the intended use of the medical device and its features. All statements made by the manufacturer should be based on the appropriate scientific justification.

6. Quality Management System certificate confirming that the quality management system implemented by the manufacturer complies with the applicable requirements. The document should be issued by the recognized entity.

7. Free Sale Certificate or Certificate of Marketing Authorization. In addition to the marketing history, an applicant should provide valid certificates issued by the national authority of the jurisdiction when the product is approved for marketing and use.

8. Declaration of Conformity (DOC).

According to the guidance, the labeling should contain the following information about the medical device:

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).

In summary, the present guidance issued by the EFDA outlines the main eligibility criteria low-risk medical devices should meet in order for the simplified framework to be applicable. The document also describes the content of the submission to be filed by an interested party intended to place a medical device on the market via the notification procedure.

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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