Certificate of Competence: Premises and Personnel Requirements in Ethiopia

1. Key takeaways

The Certificate of Competence (CoC) is Ethiopia’s authorization of an establishment, not of a product, issued by EFDA through the i-License module of eRIS. It has two legal anchors: Article 23(1) of Proclamation No. 1112/2019 (establishments carrying out the relevant activities must obtain a license), and item 9.2.3(h) of EFDA-GDL-046 (an agent handling imports on behalf of a manufacturer must hold the Ministry of Trade license and an EFDA-issued CoC at the time of import). The regulatory triangle is strict: the product needs an MA, the entity needs a CoC, and each consignment needs an import permit; no line of the triangle can be missing. One caution applies throughout this article: regarding specific technical conditions for the CoC, such as premises area, dedicated staffing levels, cold chain and temperature-humidity monitoring facilities, the publicly verifiable authoritative texts (Directive No. 872/2022 and its accompanying checklists) could not be obtained in full during this verification round, so every dimension involving specific technical parameters below is marked as a practical estimate, and companies must follow the CoC application requirements and on-site inspection checklists currently published by EFDA.

2. Legal basis

3. Expert insights

Insight 1: The CoC binds the person, the MA binds the thing, and the two are constantly conflated.

Many companies read the fact that a product is registered as permission to handle the import themselves, overlooking the independent licensing requirement for establishments under Article 23(1). If the importing entity is not a licensed agent, or if the agent’s CoC has expired, the goods will still be stopped at the port even though the product MA is fully valid. The two authorizations are examined by different officers, at different nodes, against different criteria, and neither substitutes for the other. This separation is the structural reason why import planning in Ethiopia must be built around entities as well as products.

Insight 2: The judging point for the CoC is embedded in the agency agreement conditions, with contractual knock-on effects.

Item 9.2.3(h) makes holding the CoC at the time of import one of the eight conditions of the agency agreement. A missing CoC is therefore not merely a customs problem: it renders the agency agreement itself non-compliant with EFDA’s conditions, which in turn undermines the validity of the registration application built on that agreement. A single expired certificate can thus cascade backwards through the entire authorization chain, which is why CoC renewal dates deserve the same calendar discipline as MA expiry dates.

Insight 3: The submission form for the CoC has already been standardized.

Under the instructions of Annex IV of EFDA-GDL-046, the agency agreement submission must be accompanied by a valid scanned PDF of the CoC. This shows the CoC has entered the online verification chain of eRIS; the paper copy is no longer the sole credential, but it also means the certificate status must be retrievable in the system. If a paper certificate exists but the electronic record is not current, the verification chain breaks at exactly the point where the authority checks it.

Insight 4: The practical inspection dimensions (practical estimate, subject to the current official documents).

EFDA’s on-site attention to warehousing and trading establishments typically concentrates on: whether the business premises are independent and separated from non-business activities; whether dedicated technical personnel with the relevant professional background are in place; whether storage conditions and temperature-humidity monitoring are matched to the product range handled; whether traceable purchase and sales records are maintained; and whether the responsibilities of the quality manager are documented in writing. These are the industry’s common preparation directions; the specific items and judging criteria must follow the CoC application requirements and on-site inspection checklists currently published by EFDA.

4. Practical recommendations

1. Fix the entity before fixing the product: before starting the MA application, confirm the local agent’s CoC status and that its business scope covers the device category.
2. Put the CoC validity period into the import calendar: CoC and MA expiry dates do not coincide, so separate early-warning reminders must be set for each.
3. Self-inspect along four lines: people, premises, records, temperature (practical estimate): appointment documents for dedicated technical staff, floor plans and premises independence, purchase and sales record ledgers, and temperature-humidity monitoring with deviation-handling records.
4. Prepare the authorization chain for foreign entities: the power of attorney and the agency agreement under which the foreign manufacturer authorizes the local agent must be consistent with the entity named on the CoC.
5. Obtain the official checklist early: request the current CoC application requirements and inspection checklist directly from EFDA or a local adviser, rather than importing checklists from other markets that may not match Ethiopian practice.
6. Verify the electronic record, not just the paper: confirm the CoC appears correctly in eRIS before any submission that references it.

5. Verification checklist

• □ Confirmed that the importing / trading entity must hold a CoC (Article 23(1))
• □ The agency agreement satisfies the condition of item 9.2.3(h)
• □ The current EFDA CoC application requirements and on-site inspection checklist have been obtained
• □ Premises independence and layout meet the checklist requirements (practical estimate)
• □ Appointment and qualification documents for dedicated technical personnel are complete (practical estimate)
• □ Temperature-humidity monitoring and storage facilities are in place with records (practical estimate)
• □ Purchase and sales record ledgers are traceable (practical estimate)
• □ A scanned PDF of the CoC is available for eRIS submission

Regulatory information verified as of October 29, 2026. The parts of this article verifiable in official texts are Articles 20(1) and 23(1) of Proclamation No. 1112/2019 and Section 9.2.3(h) and Annex IV of EFDA-GDL-046; content involving specific technical conditions such as premises area, staffing levels and cold-chain facilities is practical estimate only and must follow the documents currently published by EFDA.

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 CoC applications, premises readiness and local authorized representative support in the Ethiopian market, GRZAN can also be reached at info@grzanglobal.com.