Ethiopia Non-IVD Device Registration Dossier under EFDA/GDL/097 Version 002

1. Key takeaways

The registration dossier for non-IVD medical devices in Ethiopia must be organized in accordance with EFDA/GDL/097, the Guideline for Requirements of Registration of Non-IVD Medical Devices, Version 002. This version was approved on June 15, 2026 and entered into force on June 30, 2026; the first edition was issued in 2022. The stated rationale for the revision is unambiguous: to align the requirements with the World Health Organization Global Benchmarking Tool (GBT) for medical device evaluation and to comply with EFDA document control principles. Any dossier prepared today that still follows the 2022 structure is therefore out of step with the current regulatory expectations.

The dossier consists of six chapters: Chapter 1, administrative documents; Chapter 2, submission background; Chapter 3, non-clinical evidence; Chapter 4, clinical evidence; Chapter 5, labelling (including electronic labelling); and Chapter 6 (6A/6B), quality management system and GMP evidence. Each chapter serves a distinct review purpose. Chapter 1 establishes eligibility to apply, Chapter 2 defines what the device is, Chapters 3 and 4 carry the technical and clinical proof, Chapter 5 governs what reaches the user, and Chapter 6 confirms the manufacturing environment behind the product.

Two practical consequences follow. First, the administrative documents in Chapter 1 are all eligibility documents, and any missing item is likely to trigger a return at the screening stage rather than a request for correction during assessment. Second, because the Version 002 revision explicitly pursues WHO GBT alignment, and EFDA launched a WHO self-assessment of its medical device regulatory system on July 28, 2026, the dossier requirements should be treated as a moving target that continues to converge with international practice.

2. Legal basis

3. Expert insights

Insight 1: the revision rationale of Version 002 is itself a signal. The document history table states that the purpose of the revision is to align the requirements with the World Health Organization GBT medical device evaluation tool. Taken together with the WHO self-assessment of the medical device regulatory system that EFDA launched on July 28, 2026, it can be concluded that the dossier requirements are in a process of continuous international benchmarking. Manufacturers can no longer rely on the structure of the 2022 first edition when preparing their submission files, and they should monitor the guideline for further updates during the lifecycle of their registration.

Insight 2: Chapter 1 contains eight administrative documents covering agreements, systems and declarations. They include: the cover letter; the agency agreement; the proof of payment of the registration application fee; the quality management system documentation; the Good Manufacturing Practice (GMP) certificate; the Certificate of Free Sale or Certificate of Marketing Authorization; the attestation of absence of TSE/BSE risk; and the Declaration of Conformity. All eight are eligibility documents, and the absence of any one of them will result in the dossier being returned at the screening stage. Companies should treat this list as a hard gate before submission rather than as a checklist to complete afterwards.

Insight 3: Chapter 2 breaks the question of what the device is into four reviewable dimensions. They include: the submission overview; the device description (covering the comprehensive description and principle of operation, the packaging description, the development history, the reference comparison with similar or previous-generation products, and the discussion of substantial equivalence); the intended use, indications and contraindications (covering the intended use environment, paediatric use and use contraindications); and the global marketing history. The fact that the discussion of substantial equivalence is listed as a standalone item shows that the authority attaches importance to comparative argumentation against products already on the market.

Insight 4: Chapter 3 on non-clinical evidence is the most technically demanding chapter. It covers risk management; the Essential Principles (EP) checklist; standards; non-clinical studies (physical and mechanical characterization, chemical and material characterization, electrical system safety and electromagnetic compatibility, radiation safety, software and firmware, biocompatibility and toxicology, non-material-mediated pyrogenicity, safety of biological source materials, sterilization validation, and animal testing); non-clinical literature; and shelf life and packaging verification (including product stability and packaging verification). Each of these items must be individually addressed, with a reasoned justification wherever an item is claimed not to apply.

Insight 5: Chapter 5 places electronic labelling on an equal footing with physical labelling, reflecting changes in how products are delivered. Chapter 5 contains three sections: the product and packaging label, label content, and the electronic label (e-labelling). This means that paper labelling is no longer the only acceptable form, but an electronic label must satisfy the conditions set out in the guideline and cannot be assumed to apply by default. Manufacturers of standalone software and connected devices should examine these conditions early, because the choice of labelling format affects the layout of the whole Chapter 5 submission.

4. Practical recommendations

1. Rebuild the dossier table of contents around the six-chapter structure of Version 002: do not reuse templates based on the 2022 edition.
2. Complete the eight eligibility documents of Chapter 1 first: this is where most returns at the screening stage occur.
3. Prepare the discussion of substantial equivalence as a standalone section in Chapter 2: compare the device against products already on the market.
4. Assess the applicability of each of the ten categories of non-clinical studies in Chapter 3 item by item: where an item does not apply, state the reason explicitly.
5. Adopt electronic labelling only after confirming it case by case: and explain the confirmation in the dossier.
6. Maintain an evidence index mapped one to one to the chapters of Version 002: this makes review and verification straightforward.

5. Verification checklist

• □ EFDA/GDL/097 Version 002 has been obtained and the effective date of June 30, 2026 has been confirmed
• □ The dossier table of contents has been organized according to the six-chapter structure
• □ All eight administrative documents of Chapter 1 are complete and valid
• □ Chapter 2 contains the discussion of substantial equivalence and the global marketing history
• □ Chapter 3 has assessed and justified each of the ten categories of non-clinical studies item by item
• □ Chapter 5 explains the applicable conditions for electronic labelling

Regulatory information verified as of October 29, 2026. The dossier structure, chapter items and effective dates listed in this article are based on the current text of EFDA/GDL/097 Version 002; when the guideline is revised again, 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.