Declaration of Conformity and UMDN Coding for Medical Devices in Ethiopia

1. Key takeaways

Ethiopia requires manufacturers to issue a written Declaration of Conformity (DoC) and prescribes that it contains at least seven items of content. The two items most easily overlooked by manufacturers from the Chinese mainland are: the requirement to state the Universal Medical Device Nomenclature (UMDN) code of the device, and the requirement that the declaration be signed by the person authorized to complete it on behalf of the manufacturer, with the name and position stated. The DoC is the manufacturer’s single-point commitment of responsibility for all regulatory requirements, and it must be continually updated.

The DoC appears on every regulatory path in Ethiopia: the full assessment route (Section 1.8 of EFDA/GDL/097), the low-risk route (Section 6.1.8 of EFDA-GDL-092) and re-registration (item e of Section 12.1) all require it to be submitted, and Annex 6 of EFDA-GDL-046 supplies the official template. Because the declaration states conformity with the applicable Essential Principles and labelling and IFU requirements, any non-conformity discovered in those areas also renders the DoC inaccurate, which is why the document is treated as a living instrument rather than a one-time formality.

The most consequential technical detail is the nomenclature. Ethiopia requires the UMDN code, not the GMDN code, on the DoC. Copying a DoC template from another market that uses GMDN codes produces a defective mandatory field, and this defect is easy to introduce precisely because the template looks otherwise identical. Checking the code system is therefore the first verification step for any DoC destined for Ethiopia.

2. Legal basis

3. Expert insights

Insight 1: the seven minimum items together form a complete declaration of responsibility. Section 9.2.5 lists: (1) a declaration that each device covered by the declaration conforms to the applicable Essential Principles of Safety and Performance and the applicable labelling and instructions for use requirements; (2) information sufficient to identify the devices to which the declaration applies; (3) the Universal Medical Device Nomenclature (UMDN) code of the device; (4) the classification of the device determined under the classification principles; (5) the date of issue of the declaration; (6) the name and address of the manufacturer; and (7) the name, position and signature of the person authorized to complete the declaration on behalf of the manufacturer. Treating these seven fields as a completeness gate before signature prevents the most common omissions.

Insight 2: the UMDN code rather than the GMDN code is a substantive difference between Ethiopia and some other markets. Section 9.2.5 explicitly requires the UMDN code. The abbreviations table of the low-risk guideline lists both GMDN and IMDRF, showing that the nomenclature context is in transition, but the mandatory field of the DoC is currently UMDN. Copying a DoC template from another market that uses GMDN codes will directly produce a missing field. Manufacturers should verify the code system on every DoC signed for Ethiopia, including renewals of documents originally drafted for other jurisdictions.

Insight 3: the object of the declaration is the Essential Principles, not a given standard or a system certificate. The first item of Section 9.2.5 requires a declaration of conformity with the Essential Principles and the labelling and IFU requirements; Section 7.4 requires the declaration that the requirements of the guideline and related documents have all been met. Writing conformity with ISO 13485 does not satisfy the requirement; a system certificate and a product declaration of conformity are two different things. The DoC must speak about the device, its classification and its Essential Principles conformity, while the QMS certificate is filed separately as Chapter 1 evidence.

Insight 4: the DoC is a living document and must be continually updated. Section 7.4 provides expressly that the manufacturer must update the Declaration of Conformity continually. Design changes, process changes and changes to the conditions of registration abroad can all invalidate an existing DoC. A workable internal rule is to link the DoC review to the change management process: whenever a notifiable change is evaluated, one of the checklist questions should be whether the DoC requires re-issue, and each issued version should be archived with its effective date.

Insight 5: the DoC is a mandatory item on every route. The full assessment route (Section 1.8), the low-risk route (Section 6.1.8) and re-registration (item e of Section 12.1) all require the DoC to be submitted. There is no route from which it can be waived. Even a notification-style submission for low-risk devices must carry it, so a market-entry plan that treats the DoC as relevant only to high-risk dossiers will fail at the first screening.

4. Practical recommendations

1. Complete the seven items one by one using the Annex 6 template: no item may be omitted.
2. Verify the UMDN code device by device: do not carry over GMDN codes.
3. Make the Essential Principles the object of the declaration: do not cite system standards generically.
4. Bring the DoC into change management: significant changes require re-signature and version archiving.
5. Update the DoC in step with re-registration: Section 12.1 lists it as mandatory documentation.
6. The signatory must be an authorized person with name and position stated: a company seal cannot substitute.

5. Verification checklist

• □ The DoC has been issued using the Annex 6 template
• □ The UMDN code (not GMDN) has been stated
• □ Conformity with the Essential Principles and the labelling and IFU requirements has been declared
• □ The device classification and the date of issue have been stated
• □ The manufacturer name and address and the signatory name, position and signature have been stated
• □ A mechanism for DoC change updates and version archiving has been established

Regulatory information verified as of October 29, 2026. The seven items of the DoC, the UMDN requirement and the template source listed in this article are based on the current text of EFDA-GDL-046 Section 9.2.5 and Annex 6; when the template is 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.