Import Permit and Port Clearance for Medical Devices in Ethiopia

1. Key takeaways

In Ethiopia, holding a market authorization (MA) does not by itself permit importing. The product must first obtain an Import Permit through the i-Import module of the eRIS platform, and the shipment must then clear customs at the port of entry. Three links form one complete chain: MA (i-Register) → CoC (i-License) → Import Permit and clearance (i-Import). The import permit (purchase order / pre-import permit) is valid for 12 months and is non-transferable; it may cover one or multiple shipments and allows partial deliveries; but once it expires or is cancelled, no quantity of product may be imported or supplied any further. The importing agent must hold a license issued by the Ministry of Trade and a Certificate of Competence (CoC) issued by EFDA, and this requirement is judged at the time of import (EFDA-GDL-046 Section 9.2.3(h)). Treating the MA certificate as a customs document is the most frequent and most expensive mistake in this chain.

2. Legal basis

3. Expert insights

Insight 1: The import permit is an independent administrative act and is not granted automatically by holding an MA.

Article 20(1) of Proclamation No. 1112/2019 lists import among the activities that require a valid market authorization as a precondition. But the MA is an authorization over a product, while the import permit is an authorization over a consignment or an act; the objects and the approval nodes differ. Presenting the MA certificate directly at customs as if it were an import document is the most common import blockage in this market. The permit application runs through i-Import on eRIS and produces its own document with its own validity window, which customs officers verify independently of the MA.

Insight 2: The judging point for the CoC is the time of import, not the time of application.

Item 9.2.3(h) is worded so that the agent responsible for importing must hold the Ministry of Trade license and the EFDA Certificate of Competence when importing the product. This means that even if the agent had not yet obtained the CoC when the registration application was filed, the certificate must be in hand before the goods are actually imported. If the agent only starts the CoC application after the MA is granted, the import plan is pushed back by the entire CoC processing time.

Insight 3: The permit is valid for 12 months, non-transferable, and closes completely on expiry.

The clearance guideline provides that the import permit (purchase order / pre-import permit) is valid for 12 months from issuance, is non-transferable, and may cover one or several shipments with partial deliveries allowed; but once the validity period lapses or the permit is cancelled, no quantity may be imported or supplied any further. This is a hard-closure clause: there is no grace period and no remedial channel, only a fresh application. Shipment plans must therefore be built backwards from the issuance date.

Insight 4: Port documents fall into administrative and technical categories, and the administrative set is the hard gate.

The clearance guideline divides the documents required at the port into administrative documents and technical documents. The administrative set includes: a valid purchase order (PO) or pre-import permit (PIP), a valid registration certificate, the Certificate of Competence (CoC), the certificate of origin (COO), and, where applicable, a clinical trial approval letter and a prescription certificate. The COO must be signed by the exporter, countersigned by the local chamber of commerce, and must state the country of origin, the destination, the device names and models, and the quantities.

Insight 5: Personal imports are tiered by risk class.

For personal use, Class II, III and IV non-IVD devices (or Class B, C and D IVDs) may only be imported with a written prescription from a licensed physician, dentist or other authorized practitioner; Class I non-IVD devices (or Class A IVDs) may be imported with a written prescription or a medical certificate, and where no document is available, the imported quantity is limited to what the individual medical use requires.

Insight 6: The bank foreign-exchange step is a hidden function of the import permit.

In Ethiopia, payment for imports generally requires valid permit documents, so the import permit also serves as a foreign-exchange channel credential on top of its regulatory function (practical estimate: the specific documentary requirements follow the current rules of the National Bank of Ethiopia and the commercial banks, and no definitive statement is made here). Arranging foreign-exchange payment without an import permit produces a two-sided lock-up: funds blocked at the bank and goods blocked at the port.

4. Practical recommendations

1. Sequence the project plan around the three-certificate timeline: run the CoC application in parallel with the MA review so the import is not left waiting for the CoC after the MA is granted.
2. Complete three consistency checks before shipping: the MA is within its validity period, the importer named on the permit matches the actual importer, and the product names on the permit match the physical labels.
3. Move port verification upstream into an internal check: before dispatch, confirm on eRIS that the permit status can be retrieved online.
4. Reverse-plan shipments from the 12-month validity: the permit is valid 12 months from issuance and non-transferable; all partial shipments must be completed within that window; after expiry or cancellation there is no grace period and a new application is required.
5. Assemble port documents in both categories: the administrative set must include at least a valid PO / PIP, the valid registration certificate, the CoC and the COO (signed by the exporter and countersigned by the local chamber of commerce).
6. Appoint a single import interface person: let the CoC-holding import agent deal with the port uniformly, so that intermediaries do not declare customs in their own name and create an entity mismatch.

5. Verification checklist

• □ The product to be imported holds a valid market authorization (MA)
• □ The importing agent holds the Ministry of Trade license
• □ The importing agent holds a valid CoC whose validity covers the arrival date
• □ The import permit application has been submitted through the i-Import module of eRIS
• □ The importer, product names and specifications on the permit match the physical goods
• □ The 12-month validity of the permit covers all shipments and the permit has not been transferred
• □ Administrative port documents are complete: PO / PIP, registration certificate, CoC, COO
• □ The certificate of origin has been signed by the exporter and countersigned by the local chamber of commerce
• □ Permit documents for the bank foreign-exchange step have been prepared (practical estimate, to be re-checked)

Regulatory information verified as of October 29, 2026. The import permit and clearance procedures listed in this article are governed by Proclamation No. 1112/2019, Directive No. 872/2022 and the current eRIS module documentation; when the system is upgraded or the procedures are adjusted, the provisions must be re-checked.

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 import permits, port clearance and foreign-exchange documentation support in the Ethiopian market, GRZAN can also be reached at info@grzanglobal.com.