Two Parallel Classification Systems: Non-IVD Classes I–IV and IVD Classes A–D

1. Key takeaways

Ethiopia applies two parallel risk classification systems, and the symbols must never be mixed: non-IVD devices are classified as Class I, II, III and IV (Roman numerals, with I lowest and IV highest), while IVD devices are classified as Class A, B, C and D (Latin letters, with A lowest and D highest). Classification determines the depth of documentation, the elements of conformity assessment and the intensity of review, and it is the starting point of every submission. Where an applicant’s self-determined lower risk class does not match EFDA’s determination, the authority’s determination prevails. Because the two systems use deliberately different symbol sets, a class designation written in the wrong alphabet is treated as a classification error rather than a typo. Classification also reaches forward into the product life cycle: it influences whether the low-risk notification route is available, whether manufacturing site inspections are required, whether vigilance and post-market surveillance reports must accompany re-registration, and how variations are assessed. A written, factor-by-factor classification rationale is therefore not optional paperwork; it is the document on which the entire downstream regulatory strategy for the product in Ethiopia is built and defended.

2. Legal basis

3. Expert insights

Insight 1: using different symbol systems for the two device categories is a deliberate design, not an oversight. Section 5.1.1 of the general guideline explains explicitly that non-IVD devices use Roman numerals and IVDs use Latin letters, so that applicants and authority staff can easily identify and distinguish the two categories. Writing an IVD as Class I, or a non-IVD device as Class A, in a submission is treated as a classification error. Teams reusing templates from other markets must audit every class designation before filing, because mixed-symbol drafts are a recurring and entirely avoidable source of formal objections.

Insight 2: non-IVD classification turns on seven risk factors. They include whether the device maintains or supports life; whether it invades the body, and the degree and duration of invasion; whether it contains medicinal products or human or animal tissues and cells; whether it is an active device; whether it delivers medicines, energy or radiation; whether it can alter blood or other body fluids; and whether it is used in combination with other devices. These seven factors largely correspond to the internationally established classification framework, so existing European Union or Southeast Asian classification rationales can be adapted and reused with modest rework.

Insight 3: IVD classification turns on four dimensions. They include the intended use and indications stated by the manufacturer (target disease, population, condition or risk factor); the technical, scientific or medical expertise of the intended user (lay user or professional healthcare worker); the importance of the information for diagnosis (whether it is the sole determinant or one of several factors); and the impact of the test result, whether true or false, on individual and public health. The fourth dimension, public health impact, is emphasized particularly strongly in Ethiopia — HIV blood screening and HIV diagnostics are assigned to Class D precisely on this basis.

Insight 4: applicants may propose alternative classification rules, but justification is required and the authority’s determination prevails. The general guideline provides that other classification rules chosen by the manufacturer may be accepted where appropriately justified; however, where the lower risk class determined by the applicant is considered by EFDA to present a higher risk, the latter determination applies. Classification reasoning must therefore be drafted as a reviewable written document, not merely a class filled into a form. The rationale should cite each applicable factor and conclude with the resulting class, so that reviewers can follow the logic rather than re-derive it.

Insight 5: classification directly determines four downstream costs. It affects documentation depth (Class I / Class A devices may use the low-risk notification procedure); the elements of conformity assessment (for example, whether a manufacturing site inspection is required); whether vigilance and post-market surveillance reports must be submitted at re-registration (sterile devices, devices with a measuring function, and Class III / Class C and above); and the criteria for assessing changes. The consequences of a classification error amplify across the entire product life cycle, which is why the classification file deserves the same rigor as the dossier itself.

4. Practical recommendations

1. First determine whether the product is an IVD or a non-IVD device, then apply the corresponding symbol system: the two sets must not be mixed.
2. Justify the class in writing, factor by factor, using the seven or the four applicable factors; do not merely record the result.
3. When reusing existing international classification rationales, add the local argument, especially the public health impact dimension for IVDs.
4. Where the class is uncertain, prepare the dossier to the higher class to avoid being upgraded during review.
5. Record the risk class in the Declaration of Conformity: the DoC must state the classification.
6. When the class changes, reassess the submitted dossier and the applicable variation route at the same time.

5. Verification checklist

• □ Determined whether the product is an IVD or a non-IVD device
• □ Used the correct symbols under the corresponding system (Class I–IV or Class A–D)
• □ Completed the written rationale under the seven or the four applicable factors
• □ Stated the risk class in the Declaration of Conformity
• □ Assessed the impact of classification on documentation depth and re-registration obligations

Regulatory information verified as of October 29, 2026. The classification systems, determination factors and examples listed above are based on the current text of Section 5.1 of EFDA-GDL-046; where the classification 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.