Screening and Evaluation Process for Medical Device Applications in Ethiopia

1. Key takeaways

Ethiopian marketing authorization applications pass through two stages: Screening — a check of whether the application is well organized, whether the required forms and documents are complete, and whether it meets the eligibility requirements of the chosen approval pathway; and Evaluation — the substantive review of the administrative and technical documents. Review staffing follows a fixed pattern: new-type non-SRA applications are reviewed by two reviewers in sequence, all other types are reviewed by one reviewer, and the team leader conducts the final review. Applications that fail screening never reach scientific review — this is the principal source of lost time.

The fee schedule confirms the independence of the two stages: screening of a new application costs 350 birr and evaluation costs 1300 birr under the service fee regulation. Read together with the staffing rules, the message to applicants is clear: the fastest route to approval is not persuasion but preparation — a file that is well structured, complete and matched to the declared pathway passes the first gate quickly and enters evaluation with its credibility already established, while a disorganized file pays for its defects at both gates.

2. Legal basis

3. Expert insights

Insight 1: screening is a formal, separately charged stage. Regulation No. 370/2015 lists screening and evaluation as two independent fee items (350 birr and 1300 birr), which shows that screening is not a complimentary preliminary to evaluation but an independent administrative review step. The treatment of the evaluation fee when screening is failed, and the cost of re-application, must be calculated in advance. Budgets that assume a single uninterrupted pass from submission to certificate underestimate the process, and the gap is felt precisely by the applicants who are least prepared.

Insight 2: the three screening checks determine the most frequent grounds for return. Section 11.1 states that screening examines whether the application is well organized; whether all required forms and relevant documents have been submitted; and — as described in Section 11 — whether the application meets the eligibility requirements of the chosen approval pathway. The three correspond to dossier structure, documentary completeness and pathway selection, which are exactly the three places where companies most often go wrong. A pre-submission self-check built on these three headings costs hours and prevents weeks of delay.

Insight 3: the two-reviewer allocation for new non-SRA applications is the institutional source of the time differences. Section 11.2 explains that an application is assigned to one reviewer, but that new-type non-SRA applications are assigned to two reviewers who review in sequence. This corroborates the shorter processing time of the SRA route — pathway selection directly affects the review resources invested. Applicants choosing the Full Assessment route should plan for the doubled review layer in their timelines rather than treating the SRA and non-SRA durations as interchangeable.

Insight 4: queries follow a model of completing the review first, then consolidating the questions. Section 11.2 describes the sequence: the review is carried out on the information submitted; a list of questions is then issued to the applicant with a response deadline; and the responses are evaluated over one or more rounds before the decision is made. This means response quality matters more than response speed — one high-quality response is worth more than three rounds of supplements. Preparing the response as a complete, evidence-linked package, rather than a partial answer sent early, is the single most effective way to shorten the evaluation stage.

Insight 5: the review is evidence-based and permits post-approval studies to supply information. Section 11.2 states that the reviewers determine the information needed to decide on approval of the product, and consider whether further information could be obtained in post-approval studies without compromising safety. For products whose early evidence is incomplete but whose risk is controllable, this is a path that can be actively pursued. The proposal must itself be credible — with defined endpoints and timelines — since the reviewer is being asked to trade immediate certainty for a managed commitment.

4. Practical recommendations

1. Self-check against the three screening items before submission: structure, documents, pathway eligibility.
2. List the screening fee and evaluation fee separately in the budget: and reserve for the possibility of re-application.
3. Prepare non-SRA applications to the depth of a two-reviewer review: expect a longer evaluation cycle.
4. Answer the question list once, at high quality: reduce the number of rounds.
5. Where evidence is thin, propose a post-approval study proactively: pursue the conditional route deliberately.
6. Track status throughout through the local agent: foreign entities cannot query the system directly.

5. Verification checklist

• □ Pre-submission self-check completed against the three screening items
• □ Screening fee and evaluation fee paid separately and receipts retained
• □ Chosen pathway confirmed consistent with the submitted materials (no non-SRA application mislabeled as SRA)
• □ Owners and deadlines prepared for the question-list response
• □ Need for a post-approval study proposal assessed
• □ Review status tracking mechanism established through the local agent

Regulatory information verified as of October 29, 2026. The review stages, reviewer staffing and fee items described in this article follow Section 11 of EFDA-GDL-046 and the current text of Regulation No. 370/2015; when the process or fee rates change, the content must be re-verified.

• Ethiopia local resource: GRZAN supports manufacturers from the Chinese mainland and overseas in working with the Ethiopian Food and Drug Authority (EFDA) on marketing authorization (MA) applications, the institutional competency certificate (CoC) and import permit applications, including local agent scheme design and agency agreement review, SRA reliance route justification, UMDN coding and classification determination, technical dossier preparation, and vigilance and post-market surveillance system setup.
• 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 determination, Essential Principles conformity justification, English-language labeling and instructions-for-use localization, vigilance reporting and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn. For EFDA registration pathway and classification strategy support for the Ethiopian market, write to info@grzanglobal.com.