The Ethiopian market is seeing a rise in medical devices, and ensuring their safety and effectiveness is crucial. The Food and Medicine Administration Proclamation No. 1112/2019 plays a key role in this by requiring registration for all medical devices. But there’s good news for low-risk devices!

The Ethiopian Food and Drug Authority (EFDA) understands that not all medical devices pose the same level of risk to health of the citizen. The Authority have categorized both non-invitro diagnostic (non-IVD) and in vitro diagnostic (IVD) devices into four risk classes, i.e., Class I to Class IV and Class A to Class D respectively with Class I and Class A representing devices with the lowest risk.

This blog focuses on these low-risk devices and how to get them approved for the Ethiopian market with a simplified process.

Why a Simplified Process?

The idea behind the relaxed requirements for Class I/A devices is twofold:

• Resource Efficiency: By streamlining the approval process, EFDA can dedicate more resources to evaluating higher-risk devices.
• Accessibility: Easier approval paves the way for faster availability of these essential medical devices for Ethiopian consumers.

What Does “Low-Risk Approval” Mean?

While Class I/A devices are exempt from extensive evaluation and registration, they still need to meet specific safety and performance standards. Here’s what you need to know:

• Abbreviated Assessment or Notification Procedure: These devices qualify for a faster approval process that doesn’t involve a full-blown evaluation.
• Essential Principles Adherence: Even with a simplified process, Class I/A devices must demonstrate adherence to basic safety and performance principles outlined by EFDA.

Important Note:

Not all Class I/A devices qualify for the low-risk approval pathway. For example, sterile devices and measuring devices might require a more thorough evaluation.

Who is this Guide For?

This guide is intended for anyone seeking to bring low-risk medical devices to the Ethiopian market. It clarifies the requirements for obtaining marketing authorization through the simplified procedure.

Navigating Low-Risk Medical Device Marketing Authorization with the EFDA

Are you a manufacturer of medical devices aiming for a smooth marketing authorization (MA) process in Ethiopia? If your product falls under the category of low-risk medical devices, this blog post can be your guide.

This post dives into the guidelines set by the Ethiopian Food and Drug Authority (EFDA) specifically for low-risk devices. We’ll explore the scope of these guidelines, the criteria for inclusion in the low-risk category, and what to do if your device isn’t on the existing list.

Understanding the Scope

The EFDA’s low-risk medical device guidelines apply to:

• Class A In Vitro Diagnostic (IVD) devices
• Class I medical devices (excluding IVD) listed in the annex of the guideline.

Qualifying for Low-Risk Status

Generally, medical devices classified under Class I/A (as per EFDA’s classification guidelines) are considered for inclusion in the low-risk list, with some exceptions:

• Sterile Devices: Due to the heightened risk associated with sterility, these devices are excluded.
• Measuring Devices (with some exceptions): The specific requirements for measuring devices can vary, so refer to the official guidelines for details.

Here are some additional factors considered for inclusion in the low-risk category:

• Compliance with Manufacturing and Quality Standards: The device’s manufacturing process and quality control measures must adhere to established standards.
• Perceived Low Risk: The device should pose minimal risk to patients and users.
• Alternative Conformity Assessments: There should be other options available for assessing the device’s conformity besides the full MA procedure.
• Similar Devices in the Same Category: If multiple devices from a manufacturer fall under the same category within the annex, they can potentially be submitted under a single application.

Not on the List? Don’t Fret

If your device meets the low-risk criteria but isn’t currently listed, you can still apply for MA. However, the inclusion request will be considered during the next revision period of the list. In the meantime, you can proceed with the regular MA application route.

By understanding these guidelines, you can navigate the EFDA’s MA process for low-risk medical devices more efficiently. Remember to consult the official EFDA guidelines for the most up-to-date information.

Getting Your Low-Risk Medical Device Approved in Ethiopia: A Step-by-Step Guide

Thinking of bringing your low-risk medical device to the Ethiopian market? Great news! The process is designed to be streamlined for these types of products. This guide will walk you through the requirements and steps to get your device to be approved by the Ethiopian Food and Drug Authority (EFDA).

Before You Apply

• Check the List: Make sure your device qualifies as low-risk. EFDA maintains an updated list (Annex I) to confirm eligibility.

Required Documents

• Application Form: Fill out and sign the official form (Annex II) requesting registration for your specific device.
• Device List: Provide a table outlining each product you’re registering, including details like generic and brand name, intended use, and technical specifications (Annex IV format).
• Authorization and Agreements: If you have a local agent or representative, include a signed agreement outlining their role.
• Marketing History: Summarize the device’s marketing status in other countries (approved, pending, withdrawn, etc.). For approved countries, provide relevant paperwork.
• Product Information: Submit product labeling and packaging that adheres to EFDA’s guidelines. All information should be in English or Amharic and consistent with claims made elsewhere. Brochures or manuals in these languages may also be required.
• Quality Management System Certificate: Demonstrate a valid ISO 13485 certificate or equivalent, ensuring your manufacturing processes meet quality standards.
• Free Sale Certificate (or Marketing Authorization): If you don’t have a CE certificate, provide a free sale certificate from the device’s origin country confirming its marketability.
• Declaration of Conformity: Submit a completed Declaration of Conformity document as per EFDA’s guidelines.

Service Fee

• Each application requires a service fee. Refer to the current medical device market authorization guideline for the exact amount.

Post-Approval

• Changes: Any modifications to your product after approval require a variation application following EFDA’s post-approval change notification guideline. For low-risk devices, this may only involve updating relevant certificates.
• Re-Registration: Every five years, you’ll need to re-register your device with EFDA. This involves submitting renewal fees and documents demonstrating continued compliance.

By following these steps and providing the necessary documentation, you can efficiently navigate the Ethiopian medical device approval process for your low-risk product.

Looking for More Information?

EFDA has published detailed guidelines for classifying medical devices. By understanding your device’s classification, you can determine if it qualifies for the low-risk approval pathway.

This blog post provides a starting point. For comprehensive details, consult EFDA’s official resources.

Please do not hesitate to contact Ethiobiomedical if you have further questions or need additional guidance for registering your products with EFDA.