Official Fee Schedule under Council of Ministers Regulation No. 370/2015

1. Key takeaways

Official fees for medical device registration in Ethiopia are set by Council of Ministers Regulation No. 370/2015 (Rate of Service Fees), and are itemized by application category in Section 9.2.4, Table 6 of the EFDA General Guideline for Market Authorization of Medical Devices (EFDA-GDL-046, Fourth Edition, January 2022). The schedule contains seven items in total: new application screening 350 Birr, new application evaluation 1300 Birr, laboratory testing 200 USD, re-registration application evaluation 870 Birr, major change application evaluation 870 Birr, minor change application evaluation 650 Birr, and agency agreement 50 USD. Critically, two items are denominated in US dollars and five in Ethiopian Birr. This mixed-currency structure is the single most common source of budgeting errors in this market: applicants who consolidate everything into one currency line, or who convert at an assumed rate without checking which items are officially pegged to USD, routinely under-budget or over-budget specific steps of the process. Every figure below traces back to the two instruments cited above, and every payment is tied to a specific procedural gate.

2. Legal basis

3. Expert insights

Insight 1: The fee is split into a screening leg and an evaluation leg by design, not by accident.

Table 6 breaks the official charge for a new application into screening at 350 Birr and evaluation at 1300 Birr, a combined 1650 Birr. The split mirrors the two-stage review architecture of EFDA: the authority first completes an administrative completeness screening of the dossier, and only after the file passes does it proceed to technical evaluation. For applicants, the practical consequence is that each payment receipt is itself the proof of having cleared a procedural node. If the screening fee has not been paid, the dossier does not advance to the next stage at all, regardless of how complete the technical content is. Budgeting should therefore track the two legs separately, because a missing screening receipt can stall a file that is otherwise ready for review.

Insight 2: The laboratory testing fee is priced in US dollars and is not triggered by every application.

Laboratory testing at 200 USD appears in Table 6 alongside screening and evaluation, but whether it is actually triggered depends on whether EFDA requires the product to undergo laboratory testing. Treating the testing fee as a mandatory line item in the budget of every submission is a common cost miscalculation that inflates projected entry costs. The opposite error is equally damaging: if a product is selected for testing and no budget was reserved for that 200 USD item, the file stalls directly in the review stage until the payment is made and evidence of payment is supplied. A practical estimate approach is to hold the amount as a contingent reserve and release it only upon an official request.

Insight 3: Re-registration and major changes carry the same fee, signaling equal review workload.

The re-registration application evaluation fee of 870 Birr is identical to the major change application evaluation fee of 870 Birr; both sit at roughly two-thirds of the 1300 Birr charged for a new application evaluation, while minor changes at 650 Birr are priced notably lower. This gradient reveals EFDA’s pricing logic: fees are set by review workload, not by certificate status. A major change is priced the same as re-registration because both require substantive re-examination of safety and performance evidence, whereas a minor change entails a lighter documentary check. Applicants should read the fee schedule as a proxy for the depth of scrutiny each pathway will attract.

Insight 4: The agency agreement fee is dollar-denominated and follows its own payment and filing routine.

The agency agreement fee of 50 USD is the only one of the seven items that arises before the registration application itself. It must be paid into EFDA’s account at the Commercial Bank of Ethiopia (CBE). Under the instructions of Annex IV of EFDA-GDL-046, the agency agreement submission must be accompanied by proof of payment, a soft-copy PDF, and the signed paper original from both parties (sent through unopened DHL packaging to the archive room), and the body of the agreement must not exceed 5 pages. Because this fee and its documentary routine precede everything else, a delay or defect at this stage delays the entire registration timeline, not merely one supporting document.

4. Practical recommendations

1. Budget in two layers: mandatory plus contingent. Mandatory items are screening at 350 Birr plus evaluation at 1300 Birr; the contingent item is laboratory testing at 200 USD, payable only if the authority requires it.
2. Keep Birr and USD accounts separate. The Birr-denominated items and the USD-denominated items should be tracked on separate ledgers; the USD items (laboratory testing and the agency agreement) require an additional reserve for exchange-rate movement and the time cost of cross-border payment.
3. Retain every payment receipt. Annex V of EFDA-GDL-046 provides the application formats for payment of service fees covering agency agreements, screening, evaluation and laboratory testing; receipts must be uploaded to eRIS together with the application.
4. Budget major changes at 870 Birr, not at the minor-change rate. Misclassifying a change leads to an underpayment that gets the file returned, costing more time than the fee difference itself.
5. Time the payment correctly. Table 6 states uniformly in its When to pay column that fees fall due before dossier submission or simultaneously with the submission; in practice, upload the receipt together with the application (practical estimate: the specific payment channel follows the current eRIS prompts and EFDA payment notices).
6. Re-verify rates before each submission cycle. Because the schedule lives inside a fourth-edition guideline and a 2015 regulation, confirm no revision has intervened before committing a budget figure to management.

5. Verification checklist

• □ Current rates have been checked against Regulation No. 370/2015 and Table 6 of EFDA-GDL-046
• □ Birr-denominated fees (5 items) and USD-denominated fees (2 items) have been separated in the budget
• □ It has been confirmed whether this application triggers laboratory testing at 200 USD
• □ Payment receipts for screening (350 Birr) and evaluation (1300 Birr) have been obtained
• □ Payment receipt, PDF and paper original of the 50 USD agency agreement fee are complete
• □ The body of the agency agreement does not exceed 5 pages
• □ The payment application formats of Annex V have been used

Regulatory information verified as of October 29, 2026. The seven fee items listed in this article are governed by the current text of Council of Ministers Regulation No. 370/2015 and Table 6 of the fourth edition of EFDA-GDL-046; whenever rates or currency conversion arrangements change, the official announcements must be re-checked before relying on any figure above.

Local resource in Ethiopia: GRZAN supports manufacturers from the Chinese mainland and overseas in engaging with the Ethiopian Food and Drug Authority (EFDA) on market authorization (MA), Certificate of Competence (CoC) and import permit applications, including local agent structuring and agency agreement review, SRA reliance pathway justification, UMDN coding and classification determination, technical documentation preparation, and the establishment of vigilance and post-market surveillance systems. Service capabilities cover product attribute determination and risk classification (non-IVD Class I–IV / IVD Class A–D), market authorization applications and re-registration, applicability assessment for the low-risk notification procedure, Essential Principles conformity reasoning, label and instruction-for-use localization in English, and vigilance reporting with field safety corrective action support. Contact: hito.lin@grzan.cn; website www.grzan.cn. For fee budgeting and local authorized representative support in the Ethiopian market, GRZAN can also be reached at info@grzanglobal.com.