Borderline Medical Device Determination in Ethiopia: Rules and Practice

1. Key takeaways

Ethiopia maintains a dedicated guideline for Borderline Medical Devices, EFDA-GDL-045, and the general guidelines also discuss the topic in Section 5.3. The determination of a borderline product centers on the manufacturer’s claimed intended use and principal intended mechanism of action: if the principal intended action is achieved through pharmacological, immunological or metabolic means, the product leans toward a medicinal product; if it is achieved by means other than those, the product falls within medical devices. Where the determination is in doubt, a written justification should be formed under the guideline first — the product should not simply be submitted.

The stakes of this determination are easy to state: the attribute conclusion decides everything downstream. It selects the classification system that applies, the dossier guideline that governs the evidence, and the department inside EFDA that handles the file. An error here is not a local mistake to be corrected in one section of the dossier — it propagates through classification, testing, documentation and review, which is why the guideline treats the written determination as a precondition rather than an optional analysis.

2. Legal basis

3. Expert insights

Insight 1: the exclusions written into the definition are the core tool of borderline determination. The definition of a medical device makes clear that its principal intended action is not achieved by pharmacological, immunological or metabolic means, while expressly allowing that such means may assist the device in achieving its function. The distinction between the principal and the auxiliary is the decisive watershed for determining drug-device combination products. A product in which the pharmacological action does the therapeutic work is a medicine; a product in which the pharmacology merely supports a mechanical or physical action remains a device — and the written determination must show which of the two is happening.

Insight 2: EFDA has explicitly benchmarked its methodology against international documents. Reference item 2 of the general guidelines cites directly the European Commission Manual on Borderline and Classification under the Community Regulatory Framework, version 1.22 (2019), together with the classification principles documents of the Global Harmonization Task Force (GHTF). This means that the European approach to borderline determination carries substantive reference value in Ethiopia. Companies that have already performed borderline analyses for the EU market can reuse the analytical structure — though not the conclusions uncritically — and present them in a form the reviewer will recognize.

Insight 3: borderline determination and classification are two separate steps taken in sequence. The question of whether a product is a device must be settled first; the question of which class it belongs to comes second. Merging the two leads to applying classification rules from a prejudged starting point, and the attribute determination is skipped altogether. The practical discipline is to file two separate written conclusions — one on the attribute, one on the class — each with its own reasoning, so that a challenge to one does not destabilize the other.

Insight 4: the conclusion of the attribute determination has effect across the whole product lifecycle. The attribute decides which classification system applies (Class I–IV or Class A–D), which dossier guideline governs (EFDA/GDL/097 or EFDA-GDL-087), and which department within the authority handles the file. If the attribute is wrong, all downstream work must be redone. This is why the determination deserves formal review inside the company before submission: the cost of an extra day of analysis is trivial compared with the cost of reclassifying a product after the dossier has been built.

Insight 5: IVDs have their own borderline questions. An IVD is defined as a device intended for the in vitro examination of specimens derived from the human body in order to provide diagnostic, monitoring or compatibility information, and stands alongside general devices as a separate category. The boundary between specimen collection devices, general laboratory equipment and IVDs must likewise be run through the determination pathway of EFDA-GDL-045. Items such as collection tubes, swabs and general-purpose laboratory instruments sit exactly where the two regimes meet, and assuming their status without a determination is a recurring source of reclassification disputes.

4. Practical recommendations

1. Determine the product attribute first, then classify by risk: the order cannot be reversed.
2. Make the intended use and principal mechanism of action the core of the determination: write it up as a documented justification.
3. Analyze drug-device combination products case by case: state whether the principal action relies on pharmacological, immunological or metabolic means.
4. Use the reasoning of the EU borderline and classification manual as a reference: always checked against local requirements.
5. Run the boundary between IVDs and general laboratory equipment through the same guideline.
6. Archive the determination and cite it in the declaration of conformity: it is easier to reference in later review.

5. Verification checklist

• □ Written determination justification for the product attribute prepared
• □ Whether the principal intended action is achieved by pharmacological, immunological or metabolic means analyzed
• □ Classification system and dossier guideline selected according to the determination
• □ EFDA-GDL-045 consulted for doubtful cases
• □ Determination archived and cited in the declaration of conformity

Regulatory information verified as of October 29, 2026. The borderline determination entry point and methodological basis described in this article follow the current text of EFDA-GDL-045 and Section 5.3 of EFDA-GDL-046; when the guidance is updated, the content must be re-verified.

• Ethiopia local resource: GRZAN supports manufacturers from the Chinese mainland and overseas in working with the Ethiopian Food and Drug Authority (EFDA) on marketing authorization (MA) applications, the institutional competency certificate (CoC) and import permit applications, including local agent scheme design and agency agreement review, SRA reliance route justification, UMDN coding and classification determination, technical dossier preparation, and vigilance and post-market surveillance system setup.
• Service capabilities: product attribute determination and risk classification (non-IVD Class I–IV / IVD Class A–D), marketing authorization applications and re-registration, low-risk notification eligibility determination, Essential Principles conformity justification, English-language labeling and instructions-for-use localization, vigilance reporting and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn. For EFDA registration pathway and classification strategy support for the Ethiopian market, write to info@grzanglobal.com.