Agency Agreements with Local Agents: Eight Conditions, USD 50 Fee and Key Risks

1. Key takeaways

To place a device on the Ethiopian market, an overseas manufacturer must sign an Agency Agreement with a local agent and pay a USD 50 agreement fee. The EFDA general guideline prescribes eight conditions (a–h) for the content of the agreement, three of which most frequently trigger rejection: the same product may not be entrusted to two agents at the same time; the agreement must remain valid for at least one year from the date of submission; and the agent handling imports must hold a Certificate of Competence (CoC) at the time of import. The agency agreement is the only link in the Ethiopian submission chain that has no substitute: there is no alternative route, no third-party structure and no grandfathering that can replace a compliant agreement with a compliant agent. Because the agreement is also the vehicle through which recall duties, vigilance duties and one-year safety evidence duties are imposed jointly on both parties, its drafting quality directly determines the manufacturer’s legal exposure years after the product reaches the market. Companies should therefore treat agency agreement drafting as a regulatory deliverable in its own right, built on the official template and reviewed clause by clause against the eight conditions, rather than as a commercial annex to be finalized quickly.

2. Legal basis

3. Expert insights

Insight 1: exclusive agency for the same product and unlimited numbers of agents are not contradictory. Section 9.2.2 provides that the license holder or manufacturer may not appoint multiple registrants or local agents for the same product at the same time; Section 9.2.3(c) then provides that for multiple devices of the license holder, there is no limit on the number of agents, but each agreement must state the agent’s sequence position (first, second or third agent). The distinction lies between the same product and different products — a boundary that must be clarified when designing the distribution channel. Multi-brand agents are permissible; competing agents for one product are not.

Insight 2: three of the eight conditions are liability-allocation clauses, not formalities. Condition (d) requires the agreement to declare that, if fraud or unforeseeable and unacceptable adverse events occur under normal conditions of use, both parties are jointly responsible for recalling the product from the market and for bearing the burden of proof. Condition (e) requires that for Class III and above devices and Class C and above IVDs, both parties collect and submit evidence of the device’s safety and performance to the authority within one year of placing it on the Ethiopian market. Condition (f) makes the parties jointly responsible for device vigilance and post-market reporting. Together these clauses bind the manufacturer and the local agent into joint and several liability.

Insight 3: the one-year validity is a minimum duration, not a recommended value. Condition (g) requires that, for administrative purposes, the agreement remain valid for at least one year from the date of submission, unless termination of the agreement is considered appropriate. Given the length of the review cycle, a one-year term carries a real risk of lapsing mid-review, with the application left without a valid legal foundation. A term covering review plus the first re-registration cycle is the safer practical estimate.

Insight 4: multi-site manufacturing changes the signing structure of the agreement. Condition (a) provides that where the product is manufactured at two or more sites, an agreement concluded between the manufacturers and a division of responsibilities among them must be submitted; in that case, the agreement between the local agent and the manufacturer is determined by the place where the documentation is kept and the registration applicant. Group companies must decide in advance which manufacturing site will act as the applicant, and fix that choice in the documentation before filing.

Insight 5: where the applicant is not the actual manufacturer, trilateral or bilateral agreements are required. Where an entity other than the actual manufacturer applies to register the product for sale in the country, there must be a validly signed agreement concluded among the actual manufacturer, the supplier and the local agent or registrant as three parties, or two agreements concluded separately between the actual manufacturer and the supplier and between the supplier and the local agent; in addition, the supplier must submit a valid licence issued by the competent local authority proving that it is engaged in the relevant activity.

4. Practical recommendations

1. Draft the agreement on the Annex IV template, mapping every clause against the eight conditions a–h.
2. Agree a term of three years or more: covering the review period and the first re-registration cycle.
3. State each agent’s sequence position explicitly to avoid conflicts in multi-product, multi-agent structures.
4. Write recall, vigilance and one-year safety evidence duties into the agreement in operative language.
5. Confirm the agent’s CoC before signing import-related clauses, or the import stage will stall.
6. For group companies, fix the applicant manufacturing site in advance and record it in the agreement.

5. Verification checklist

• □ Signed the agency agreement on the Annex IV template with both parties’ seals
• □ Paid and retained the receipt for the USD 50 agreement fee
• □ Confirmed that the same product has not been entrusted to two agents simultaneously
• □ Confirmed the agreement’s validity of at least one year from the submission date
• □ Confirmed that the agent handling imports holds a Certificate of Competence
• □ Confirmed that the agreement covers recall, vigilance and one-year safety evidence duties for high-risk devices

Regulatory information verified as of October 29, 2026. The eight conditions of the agency agreement and the fee amount listed above are based on the current text of Section 9.2 of EFDA-GDL-046 and the tariff schedule of Regulation No. 370/2015; where the template or fee is updated, 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.