Medical Device Definition under Proclamation 1112/2019: Scope, IVD and Borderline Products

1. Key takeaways

The definition of a medical device in the Food and Drug Administration Proclamation No. 1112/2019 is aligned with the International Medical Device Regulators Forum (IMDRF): any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for specific medical purposes such as the diagnosis, prevention, monitoring, treatment or alleviation of disease, and whose primary intended action is not achieved by pharmacological, immunological or metabolic means (although it may be assisted by such means), is a medical device. In vitro diagnostic devices (IVDs) are defined separately and expressly fall within the device category, not outside it. The definition is broad in two directions that matter in practice: software is named among the covered items, so standalone software is a device without any further argument, and the catch-all wording captures articles that a narrower national definition might exclude. At the same time, the definition is anchored to the manufacturer’s intended purpose, which makes labelling and claims language regulatory-relevant. Borderline questions — drug-device combinations, device-cosmetics interfaces, and general consumer goods — are handled through a dedicated guideline, EFDA-GDL-045, rather than left to the applicant’s own judgment at the point of submission.

2. Legal basis

3. Expert insights

Insight 1: the definition combines seven categories of articles with a catch-all clause, and its coverage is wide. Instruments, apparatus, implements, machines, appliances, implants, in vitro reagents, software and materials are listed, followed by the words other similar or related articles. Because software is named explicitly, standalone software is uncontroversially a device in Ethiopia — unlike markets where software status must first be confirmed through dedicated Q&A documents. Digital health products should therefore be assessed as devices from the outset of any Ethiopian project.

Insight 2: the manufacturer’s intended purpose is the first determinant of device status. The definition is qualified by the words intended by the manufacturer. The same physical article may fall inside or outside the device scope depending on the purpose the manufacturer claims for it — claims in labelling, instructions for use and promotional materials therefore carry regulatory significance and are not merely marketing copy. Changing a claim can change the product’s status, and with it the entire applicable regulatory regime, so claims management belongs to regulatory affairs rather than to advertising alone.

Insight 3: the exclusion clause on primary intended action is the dividing line for drug-device combination products. The definition states that a device does not achieve its primary intended action by pharmacological, immunological or metabolic means, although it may be assisted by such means. Device-drug combinations and devices incorporating biological materials must be analysed case by case on their primary mechanism of action; the analysis cannot be settled by looking at ingredients alone. Where the mechanism is genuinely pharmacological, the product may leave the device regime entirely, with different authorities, dossiers and timelines applying.

Insight 4: IVDs are defined separately and stand alongside, not beneath, general devices. In documents such as the adverse event report form, EFDA gives IVDs an independent definition: devices intended by the manufacturer for the in vitro examination of specimens derived from the human body to provide diagnostic, monitoring or compatibility information. Two parallel definitions exist, corresponding to two classification systems and two sets of dossier guidelines. An IVD is not a sub-category of the general device definition in the sense that its regime can be inferred from the general one; its own rules must be consulted directly.

Insight 5: borderline products have a dedicated determination route. EFDA has issued EFDA-GDL-045, the Guideline on Borderline Medical Devices, and Section 5.3 of the general guideline also addresses borderline device questions specifically. For products at the drug-device boundary, the device-cosmetics boundary, or the boundary with general consumer goods, applicants should follow the determination path of that guideline rather than self-assessing and submitting directly. An early determination request costs far less than a dossier returned wholesale after a status dispute.

4. Practical recommendations

1. Start every determination from the manufacturer’s claimed intended purpose, and cross-check labelling and instructions-for-use wording at the same time.
2. Manage software and standalone software as devices: do not omit them because they are intangible.
3. For drug-device combinations, analyse the primary mechanism of action first, and use the borderline product guideline where necessary.
4. Handle IVDs as a separate track: classify under Class A–D and compile the dossier under EFDA-GDL-087.
5. Where the product status is disputed, request a determination before submitting to avoid wholesale return of the dossier.
6. Keep a written record of every attribute determination for reference in review queries and later variations.

5. Verification checklist

• □ Determined under the Proclamation No. 1112/2019 definition whether the product is a medical device
• □ Confirmed that the manufacturer’s claimed intended purpose matches labelling and instructions for use
• □ Determined whether the product is an IVD and selected the corresponding classification system
• □ Consulted EFDA-GDL-045 for drug-device combinations or borderline products
• □ Retained written records of the attribute determination and its reasoning

Regulatory information verified as of October 29, 2026. The definitional elements and the borderline product route listed above are based on the current text of Proclamation No. 1112/2019 and the guidelines of EFDA currently in force; where definitions or guidelines are updated, the information must be re-checked.

• Ethiopia local support: GRZAN assists manufacturers from the Chinese mainland and overseas in dealing with the Ethiopian Food and Drug Authority (EFDA) on marketing authorization (MA), Certificate of Competence (CoC) and import permit applications, including local agent planning and agency agreement review, SRA reliance pathway justification, UMDN coding and classification determination, technical dossier preparation, and the setup of vigilance and post-market surveillance systems.
• 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 assessment, Essential Principles conformity justification, labelling and instructions-for-use localization in English, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.