Labelling and IFU Requirements in Ethiopia under EFDA-GDL-084

1. Key takeaways

Ethiopia has a dedicated guideline for medical device labelling, EFDA-GDL-084, the Guideline for Labelling Requirements of Medical Devices, and at the same time devotes Chapter 5 of the non-IVD dossier EFDA/GDL/097 to three sections: the product and packaging label (5.1), label content (5.2) and electronic labelling (5.3). The review requires the intended labelling and the instructions for use to be submitted as application materials. On language, the accompanying information of the registration application must be in English at minimum.

Labelling in Ethiopia is not treated as printed packaging collateral. Section 7.3 of EFDA-GDL-046 lists labelling as an independent object of proof within the technical documentation, side by side with the Essential Principles and risk analysis, and Section 9.2.5 makes the Declaration of Conformity declare conformity with the applicable labelling and IFU requirements. A labelling defect therefore propagates through the whole conformity chain: it undermines the EP checklist argument, contradicts the DoC and creates a mismatch with the residual risk disclosures expected from the risk management file.

The practical advantages for manufacturers are clear. English is a sufficient language for the accompanying information, so no additional local-language version is needed by default. And electronic labelling is available under Section 5.3, which matters for standalone software. But both advantages carry conditions: the English text must be accurate, and e-labelling must be confirmed case by case before it is adopted.

2. Legal basis

3. Expert insights

Insight 1: labelling is an independent evidence item of the technical documentation, not printed material. Section 7.3 lists labelling side by side with the Essential Principles and risk analysis as one of the objects the technical documentation must demonstrate conformity with. This means the label content must corroborate the risk management file (residual risk disclosure) and the Essential Principles argumentation. Warnings, contraindications and symbols on the label should be traceable to specific risk control measures, so that a reviewer moving from the risk file to the label finds the same information phrased consistently.

Insight 2: the declaration chain writes labelling obligations into the DoC. The first item of Section 9.2.5 requires the DoC to declare that the device conforms to the applicable Essential Principles as well as the applicable labelling and IFU requirements. Non-conforming labelling directly renders the DoC inaccurate, rather than being merely a formal defect. Because the DoC is a signed, accountable commitment, any late change to artwork, symbols or IFU wording after signature technically invalidates it, which is why labelling changes and DoC updates must be managed as a single workflow.

Insight 3: English is the language threshold for the accompanying information of the registration application. The general guideline requires, in the registration application materials part, that the accompanying information be in English at least (at least, be in English). This differs from some French-speaking African or multilingual markets: in Ethiopia English is a sufficient condition, and no local-language version needs to accompany it by default. The operative word is accuracy: translations of warnings, indications and symbols should be reviewed by someone competent in both the source language and regulatory English, because a mistranslated warning creates a genuine safety defect.

Insight 4: electronic labelling has dedicated provisions but does not apply by default. EFDA/GDL/097 Section 5.3 provides for e-labelling, showing that it is available, but its applicable conditions must be confirmed case by case. For standalone software without physical packaging, e-labelling has greater value; for conventional devices, paper labelling remains the default form. Manufacturers should decide the labelling format before the dossier is compiled, because the choice shapes the presentation of Chapter 5 and the consistency checks between the label, the packaging and the IFU.

Insight 5: the distributor’s affixing obligation is a common post-market rectification point. Under regulatory requirements generally observed in the industry, distributors must indicate the company name and contact information by means of an affixed label, so as to satisfy vigilance and post-market traceability requirements. This point is frequently checked during import and customs clearance. Agreeing in the agency agreement who prepares and applies the distributor label, and in which language, prevents the shipment from being held at the border for a correction that could have been settled on paper before dispatch.

4. Practical recommendations

1. Check the mandatory content item by item against EFDA-GDL-084: and retain the verification records.
2. Cross-check label content against the risk management file and the Essential Principles argumentation: ensure consistency.
3. Prepare the accompanying information in English at minimum: and confirm the accuracy of the translation.
4. Confirm the applicable conditions for e-labelling case by case: and explain them in the dossier.
5. Self-check in the order of packaging, label and IFU before submission: the information across the three must be consistent.
6. Agree on affixing responsibilities with the local agent: avoid rectification at customs clearance.

5. Verification checklist

• □ The mandatory label content has been checked against EFDA-GDL-084
• □ The intended labelling and the instructions for use have been submitted (Chapter 5)
• □ The accompanying information is in English at minimum
• □ The label content is consistent with the risk management file and the Essential Principles argumentation
• □ The applicable conditions for e-labelling have been confirmed and explained
• □ The information on the packaging, the label and the IFU is consistent

Regulatory information verified as of October 29, 2026. The labelling guideline, dossier items and language requirements listed in this article are based on the current texts of EFDA-GDL-084, EFDA/GDL/097 Sections 5.1–5.3 and EFDA-GDL-046; when the guidelines are updated, they must be re-checked.

• Ethiopia local resource: GRZAN can assist manufacturers from the Chinese mainland and overseas with marketing authorization (MA), Certificate of Competency (CoC) and import licence applications to the Ethiopian Food and Drug Authority (EFDA), including local agent planning and agency agreement review, SRA reliance pathway justification, UMDN coding and classification determination, technical documentation 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 application and re-registration, applicability determination for the low-risk notification procedure, Essential Principles conformity justification, labelling and IFU localization (English), and vigilance reporting and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.