Medical Device regulation and its registration process by Ethiopian Food and Drug Authority (EFDA)

Prior to their placement on the market in the territory, Ethiopia regulates medical devices just like any other countries do even though the scope and stringency of regulation may differ. The Ethiopian Food and Drug Authority (EFDA) is mandated to carry out the control of medical products including pharmaceutical products and medical devices. EFDA’s former name was Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) whose mandate also included regulating the healthcare services and health professionals competency in addition to health products and others such as food, cosmetics, tobaccos, etc. Currently, the Authority’s scope of control is narrowed to only products mentioned above while the others, healthcare services, health professionals, and healthcare facilities control are being done by the Federal Ministry of Health.

The regulation system of medical device in the country is getting better from time to time as EFDA is re-structuring itself to let the medical device sector be separate from other products and has its own dedicated departments organized to perform different regulatory functions.

The regulatory functions of EFDA can be divided into three stages of control. These are: Premarketing approval, control of placing on market, and Post-marketing control. EFDA carries out these functions by establishing different departments and teams to perform all necessary tasks that enable the authority to realize the control in a very well optimized way.

EFDA is aligning most of its regulatory functions with other internationally competent national regulatory authorities and also adopting guidance documents from World Health Organization (WHO), International Medical Device Regulators Forum (IMDRF), and others. This makes the process of registering your medical devices in Ethiopia easier and clearer than before.

This article gives you just the summary of EFDA’s medical device regulation system and its registration process. For more detail, it is possible to further read the new registration guidelines of the authority.

There is no shortcut in real life. You need to read, know, understand, and act! That's it!

Medical Devices Registration Process in Ethiopia

The conformity assessment of medical devices by EFDA starts at the stages of premarketing before the product is placed on market. This involves four major conformity assessment elements. These are: the quality management system that the manufacturer has implemented, the post-marketing surveillance system that the manufacturer has in place, the technical documentation of the subject device, and declaration of conformity that is made by the manufacturer itself to declare that its medical device complies with all applicable requirements of safety, quality and performance.

Therefore, in order to register its medical device in Ethiopia, a manufacturer must first establish and implement the Quality Management System (QMS) which starts from purchasing of raw materials to a system to conduct vigilance after the device is placed on market.

EFDA uses third party certification to ensure the conformance of the manufacturer to this requirement of medical device manufacturing QMS (eg. ISO 13485 conformance certificate issued by a competent conformity assessment body like TUV SUD can be used).

One of the most important elements of conformance evaluation of a manufacturer’s device before approval is ‘technical documentation’. A company must follow an up to date common submission dossier template (Submission table of content) developed by the authority. Currently, EFDA has two templates or submission table of contents for In Vitro Diagnostic (IVD) and medical devices other than IVD. An applicant who wishes to register its device must follow the template that is applicable to its subject device.

The flowchart below gives you a very clear idea of process to register your device with EFDA.

Medical Devices Classification System in EFDA

A, Classification of medical devices other than IVDs

The risk based classification rules are based on various criteria, such as the duration of contact with the patient, the degree of invasiveness and the part of the body affected by the use of the device, and intended use.

Accordingly, medical devices other than IVD are classified into: Class I, Class II, Class III and Class IV respectively from low to high risk.

B, Classification of In vitro Diagnostic medical devices:

IVD Medical devices are classified into: Class A, Class B, Class C and Class D respectively from low to high risk.

EFDA can also accept any other alternative classification rules selected by the device manufacturer with appropriate justification.

The following table helps you understand what EFDA requires to register before you place your device on Ethiopian market.

Medical Devices Application Types in EFDA

1. New Application:
   Is the type of document (product dossier) application made to request registration of previously unregistered products.
2. New Application through SRA procedure:
   This type of application is used to deal with products which are already evaluated and approved by one of the Stringent Regulatory Authorities (SRAs) listed by EFDA. The approval system of such devices is less strict than others.
3. Application for Re-registration:
   The validity period of marketing authorization issued by EFDA is normally five years. A marketing authorization holder who wishes to renew its status can apply for Re-registration.
4.  Application for Change Notification (Variation): This type of application is made to request EFDA to evaluate and approve any change made to the registered medical devices or facilities
5. Application for low-risk medical devices:
   EFDA has identified a list of class I Non-IVD medical devices and class A IVD devices to ease the registration submission requirements and assessment process of those devices that ultimately helps the Authority allocate its resources strategically to higher devices. This does not include devices that sterile and have measuring functions. is planning to exempt some listed non-sterile and non-measuring low risk medical devices from strict requirements and assessment. More detail information and requirements on low-risk medical device registration can be found here.

Estimated Time from Request to Approval

NB: This is not the exact duration. It is just estimation!

Ethiobiomedical is providing quality and timely consultancy services for registration of medical devices with Ethiopian Food and Drug Authority. We have been consulting manufacturers and suppliers of medical devices and In vitro diagnostics worldwide and have demonstrated outstanding experiences in handling the registration and local representation of foreign manufacturers. If you are interested to register your products with EFDA and want to consultancy services on handling registration or local representation of your company in any national regulatory mandatory activities (post-marketing surveillance, adverse event reporting, incidence investigation or acting as a contact point for EFDA), please do not hesitate to contact us .