Ethiopia IVD Registration Dossier under EFDA-GDL-087 and the IMDRF ToC

1. Key takeaways

The registration dossier for IVD medical devices in Ethiopia is organized under EFDA-GDL-087, the Guideline for Requirements of Registration of IVD Medical Devices, and adopts the In Vitro Diagnostic Submission Table of Contents (ToC) of the International Medical Device Regulators Forum (IMDRF). Consistent with Proclamation No. 1112/2019, IVDs are classified as Class A–D, entirely separate from the Class I–IV scheme used for non-IVD devices. The core evidence consists of analytical performance (limit of detection, precision, interference, stability and the like) and clinical performance (clinical agreement and clinical performance studies), and neither category of evidence can be omitted.

For manufacturers who already hold EU IVDR documentation or Southeast Asian IVD dossiers, the IMDRF ToC structure is a significant advantage, because existing files can be mapped onto the Ethiopian requirements rather than rebuilt from zero. At the same time, several Ethiopia-specific features deserve attention: quality management system conformity is currently verified through documents rather than on-site inspection, high-risk HIV assays pass through a national reference laboratory confirmation step, and the review route differs depending on whether the product has been approved by a Stringent Regulatory Authority (SRA) or prequalified by WHO.

In practical terms, an IVD submission that clearly separates analytical performance from clinical performance, supplies the QMS evidence required under Chapters 1, 6A and 6B, and states its reliance pathway up front will move through screening and review with far fewer queries than one that mixes evidence types or borrows templates from general medical device dossiers.

2. Legal basis

3. Expert insights

Insight 1: the IVD dossier adopts the IMDRF submission table of contents and connects directly with internationally accepted structures. The authority’s public statements indicate that the dossier requirements for IVD products are adopted from the IMDRF IVD submission table of contents, whose Chapter 3 requires manufacturers to submit analytical and clinical performance evaluation reports. Companies that already hold EU IVDR or Southeast Asian IVD dossiers can map their existing files directly onto the ToC. This reduces preparation time substantially and also reduces the risk that evidence is filed under the wrong chapter heading.

Insight 2: conformity of the quality management system is currently verified mainly through documents. According to the authority’s public position: although manufacturer QMS requirements have been established and on-site inspections are being advanced, conformity with the QMS requirements is at present verified through the documents required under Chapter 1 (QMS conformity certificates issued by accredited conformity assessment bodies), Chapter 6A and Chapter 6B. This provides an identical system-evidence framework for non-IVD and IVD submissions. Manufacturers should nevertheless keep their QMS certificates current, because the arrival of routine on-site inspections will turn today’s documentary check into an auditable requirement.

Insight 3: high-risk IVDs face a practical national reference laboratory confirmation step. According to the authority’s public statements: the performance of HIV serology rapid diagnostic tests must be confirmed by testing at the national reference laboratory before the assays are incorporated into the national HIV testing algorithm. The authority is also building its own capacity so that it can carry out performance evaluation at the post-market stage in the future. Although this step is not a universal requirement, it materially shapes the actual market entry path for HIV testing products.

Insight 4: the IVD review route likewise branches on SRA status. According to the authority’s public statements: for IVD registration applications that have been approved by one or more SRAs or prequalified by WHO, the review process is screening for completeness, followed by a simplified review to verify the identity of the IVD; for non-SRA applications, the process is screening for completeness, followed by an in-depth scientific review conducted by one primary reviewer and one secondary reviewer, each trained respectively in basic and advanced dossier review. This corroborates the two-reviewer arrangement described in Article 20.

Insight 5: the fourth dimension of IVD classification is an Ethiopian point of special attention. The classification criteria include the intended use and indications, the level of qualification of the intended users, the importance of the information to diagnosis, and the impact of the results, whether true or false, on individual and public health. HIV blood screening and HIV diagnostics are classified as Class D precisely because of the double high risk to individual and public health. When preparing classification rationales for Class C and Class D assays, manufacturers should address this public health dimension explicitly rather than leaving it implicit.

4. Practical recommendations

1. Organize the dossier according to the IMDRF IVD submission table of contents: existing international dossiers can be mapped directly.
2. Present analytical performance and clinical performance as separate chapters of evidence: do not merge them.
3. Complete the QMS evidence according to the requirements of Chapter 1 and Chapters 6A/6B.
4. For HIV testing products, connect early with the national reference laboratory step: reserve sufficient time.
5. For IVDs holding SRA approvals or WHO prequalification, declare the reliance pathway proactively: this can shorten review considerably.
6. In the classification rationale, address the public health impact dimension in detail: this is especially critical for Class C/D.

5. Verification checklist

• □ The dossier has been organized under EFDA-GDL-087 and the IMDRF IVD table of contents
• □ The IVD classification has been determined and the Class A–D notation adopted
• □ Both the analytical performance and clinical performance reports have been submitted
• □ The QMS evidence covers Chapter 1 and Chapters 6A/6B
• □ HIV testing products have been aligned with the national reference laboratory step
• □ SRA or WHO prequalification evidence is ready and the reliance pathway has been declared

Regulatory information verified as of October 29, 2026. The IVD dossier guideline, classification basis and review branching listed in this article are based on the current texts of EFDA-GDL-087, EFDA-GDL-043 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.