Registration Exemptions and Special Access: Four Categories, Donations and Used Devices

1. Key takeaways

Ethiopia recognizes four categories of medical devices that are not required to be registered: custom-made devices and devices for individual patient use, devices for national health emergencies, devices for research, and devices intended for research, demonstration, training, education and other non-clinical purposes. However, exemption from registration does not mean exemption from approval — the general guideline states clearly that these devices may not be imported or placed on the market without prior EFDA approval, and they must be handled under the guideline on the importation of medical devices through the special access channel. The distinction between exemption and the low-risk notification procedure is the most common point of confusion: the notification route is still a registration pathway for Class I non-IVD devices and Class A IVDs, simply simplified, whereas the four exemption categories bypass registration entirely but substitute a special-access approval. Documentation of purpose, prior approval before shipment, and the specific requirements that attach to donated and used devices — including pre-import permits, refurbishment certificates and voltage declarations — form the practical core of this regime, and each of them fails on its own if treated as an afterthought at the port of entry.

2. Legal basis

3. Expert insights

Insight 1: exemption from registration and the low-risk notification procedure are two different things, and confusing them is the most frequent error. The low-risk procedure (Section 9.5) applies to Class I non-IVD devices and Class A IVDs and is a simplified registration pathway that still requires an application and the grant of a marketing authorization; the four categories in Section 10, by contrast, are not required to be registered at all and instead follow the special-access route for import approval. Conflating the two leads either to products that should obtain a marketing authorization being pushed through the special channel, or to unnecessary review costs being incurred for devices that could have used the exemption.

Insight 2: special-access approval still exists for traceability and monitoring. The general guideline explains that the authority developed and implements the dedicated guideline in order to manage and grant import permits without compromising the safety, quality and performance of the devices, so that EFDA can monitor their safety during the period of use and, where applicable, test them. What is waived is the depth of review, not the regulation itself. Importers of exempted devices therefore remain fully visible to the authority, with records, approvals and monitoring obligations attached.

Insight 3: the boundaries of the four categories have concrete practical tests. A custom-made device must reflect individualized design for a specific patient; personal use must be distinguished from commercial distribution; a national health emergency must rest on a recognized emergency determination; and research, demonstration, training, education and other non-clinical uses must genuinely exclude clinical diagnosis and treatment. The determination turns on purpose and actual destination, not on the product itself. The same ventilator can be exempt as a training unit and fully registrable as a clinical unit, so the file must document use and flow of goods.

Insight 4: donated devices travel through the same special channel. EFDA issued EFDA-GDL-099 for donated devices, requiring a prior pre-import permit supported by the donation agreement, proof of source, proforma invoice, certificate of origin and a complete packing list, among others; the pre-import permit is valid for one year. Used devices must additionally state the year of manufacture, the previous duration of use and the manufacturer-determined lifespan, and submit a refurbishment certificate issued by a licensed refurbisher.

Insight 5: donated devices also face hard localization requirements on voltage and calibration. The donation guideline requires a declaration that the electrical requirements of single-phase equipment are set to the 220V / 50Hz standard voltage, and of three-phase medical equipment to 380V / 50Hz; X-ray emitting equipment must be calibrated and inspected by qualified personnel before shipment. These requirements deserve attention in ordinary commercial imports as well, as they are a common threshold across African markets. Equipment configured for other grids is a recurring cause of port rejection and unusable donations.

4. Practical recommendations

1. First distinguish the low-risk notification procedure from the registration-exemption special channel: the two routes cannot substitute for each other.
2. Determine exemption eligibility by use, not by product, and retain written statements of purpose.
3. Obtain approval before shipping even for exempted devices to avoid detention at the port.
4. Start the pre-import permit for donated devices three months ahead: it is valid for one year, so watch its expiry.
5. Prepare refurbishment certificates and lifespan statements for used and refurbished devices.
6. Configure and declare electrical equipment at 220V / 50Hz (single-phase) and 380V / 50Hz (three-phase).

5. Verification checklist

• □ Determined whether the device follows the low-risk notification procedure or the registration-exemption special channel
• □ Obtained prior EFDA approval for the registration-exempt category
• □ Retained purpose documentation (custom-made, personal use, emergency, research, etc.)
• □ Obtained the pre-import permit for donated devices within its validity period
• □ Prepared refurbishment certificates and lifespan statements for used devices
• □ Completed the voltage and calibration declarations for electrical equipment

Regulatory information verified as of October 29, 2026. The four registration-exempt categories and the special-access requirements listed above are based on the current text of Section 10 of EFDA-GDL-046 and EFDA-GDL-099; where the guidelines are 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.