Certificate of Competence: Qualification, i-License Procedure and Facility Requirements

1. Key takeaways

The Certificate of Competence (CoC) is the qualifying credential that an Ethiopian local entity must hold before engaging in the medical device trade. It is established under Article 23(1) of the Food and Drug Administration Proclamation and applied for through the i-License module of the electronic regulatory information system (eRIS). The procedure runs as follows: the applicant pays the assessment fee, completes the application and uploads the payment receipt together with the other required materials → personnel of the inspection and licensing directorate review the application, inspect the premises and issue the certificate; where the materials do not conform, they may demand supplementation or refuse the application. The CoC is a hard precondition both for the agency agreement (condition 9.2.3(h)) and for the import stage. Unlike a product registration, the CoC assesses an organization: its premises, its professional staffing, its storage conditions and its operating procedures. A product dossier can be prepared abroad and shipped in as a file, but the CoC can only be earned by an establishment physically present and inspectable in Ethiopia, which is why it must be the first milestone on any project plan rather than an item assumed to be already in place.

2. Legal basis

3. Expert insights

Insight 1: the CoC is an establishment certificate, entirely separate from the product marketing authorization. The former proves that this entity is qualified to trade; the latter proves that this product may be sold. A company can hold a CoC with no authorized products to its name; a product can hold a marketing authorization with no licensed importer behind it. Both must exist at the same time for any commercial act to be complete and lawful. Compliance audits should therefore test the pairing of entity and product, not the certificates individually.

Insight 2: the i-License procedure includes a substantive premises inspection. The official eRIS documentation states that personnel of the inspection and licensing directorate will review the application and inspect the facility before issuing the certificate. This is not a purely formal review — premises that fail the conditions are refused outright. The inspection covers layout, storage conditions and documentation, so applicants should schedule a full readiness check before triggering the authority’s visit rather than relying on the application review to reveal deficiencies.

Insight 3: printing errors on the certificate void the application and consume time. The eRIS documentation provides that where a printed certificate contains a printing error, the responsible officer must void the application so that the applicant can correct it and submit again. This makes it essential to fill fields such as the establishment name and address correctly on the first attempt: an error that looks typographic restarts the process rather than generating a corrected reprint.

Insight 4: the CoC and the agency agreement interlock. Condition 9.2.3(h) requires the importing agent to hold a CoC at the time of import, while the agency agreement is itself a mandatory attachment to the marketing authorization application (i-Register). Once the sequence is inverted — applying for the MA first and obtaining the CoC later — the application chain is returned at the i-Register stage. Project plans should encode the CoC as a hard dependency of the agency agreement, and the agreement as a hard dependency of the MA submission.

Insight 5: the professional staffing of the local agent is a core inspected substance. Under the standards of Directive No. 872/2022, device establishments must employ full-time registered professionals bearing technical responsibility: pharmaceutical products are handled by a registered pharmacist, while medical devices must be managed by a qualified biomedical or medical engineer. Premises must be independent and located away from environmental hazards, with a separate office area, sorting area and main storage area, and must be equipped with calibrated thermohygrometers and the necessary cold-chain facilities. These staffing and premises standards are what the inspection actually verifies.

4. Practical recommendations

1. Obtain the CoC first, then sign the agency agreement, then apply for the marketing authorization: keep the order strict.
2. Fill application fields correctly on the first attempt to avoid voiding and re-submission caused by printing errors.
3. Recruit the full-time biomedical or medical engineer early and retain employment and qualification records.
4. Configure premises with separate zones, racking and thermohygrometer monitoring, and reserve a walk-through route for inspection.
5. Set separate reminders for CoC renewal and MA renewal to avoid lapses of establishment qualification.
6. Safeguard the notarized power of attorney from the foreign principal: it will be verified during inspection.

5. Verification checklist

• □ Submitted the CoC application through i-License and paid the fee
• □ Passed the premises inspection and obtained the certificate
• □ Employed a full-time biomedical or medical engineer with qualification records on file
• □ Configured the premises with separate zones, thermohygrometer monitoring and cold-chain requirements
• □ Confirmed the validity of the CoC for the agency agreement and the import stage
• □ Established a CoC renewal reminder

Regulatory information verified as of October 29, 2026. The legal basis, application module and premises and personnel requirements of the CoC listed above are based on Proclamation No. 1112/2019, Directive No. 872/2022 and the current eRIS documentation; where the directive or system procedures are adjusted, the information must be re-checked.

• Ethiopia local support: GRZAN assists manufacturers from the Chinese mainland and overseas in dealing with the Ethiopian Food and Drug Authority (EFDA) on marketing authorization (MA), Certificate of Competence (CoC) and import permit applications, including local agent planning and agency agreement review, SRA reliance pathway justification, UMDN coding and classification determination, technical dossier 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 applications and re-registration, low-risk notification eligibility assessment, Essential Principles conformity justification, labelling and instructions-for-use localization in English, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.