Essential Principles Checklist for Medical Device Registration in Ethiopia

1. Key takeaways

Ethiopia treats the Essential Principles of Safety and Performance (EP) as the overarching framework for device conformity and, in the non-IVD dossier, EFDA/GDL/097 Section 3.2 requires submission of an EP Checklist. The method of proof is an item-by-item statement of applicability supported by an index to the evidence; items that do not apply must likewise be accompanied by a stated reason. The checklist is the only document in the dossier that links all the evidence into a single logical chain, which is why reviewers use it as their map of the submission.

The EP checklist does not stand alone. Section 7.3 of the general guideline requires technical documentation to demonstrate conformity with the Essential Principles; Section 9.2.5 requires the Declaration of Conformity to declare conformity with the applicable Essential Principles; and Article 20(4) of Proclamation No. 1112/2019 requires the dossier to be assessed for safety, quality and efficacy. Read together, these provisions form a closed loop of evidence, conclusion and commitment, and a gap in any one element will be questioned during review.

Two further points deserve emphasis. First, the depth of technical documentation is expected to scale with the device class and complexity, so a single evidence package cannot serve every risk class. Second, conformity extends beyond the Essential Principles to labelling, risk analysis and other national regulatory requirements, meaning that certain device categories, such as radiation-emitting devices, carry additional national requirements that the EP checklist alone cannot cover.

2. Legal basis

3. Expert insights

Insight 1: the Essential Principles are the conclusion, the technical documentation is the evidence, and the DoC is the commitment. Section 7.3 requires that the manufacturer, by compiling and holding technical documentation, demonstrate that the device conforms to the Essential Principles of Safety and Performance; Section 9.2.5 requires the Declaration of Conformity to declare conformity with the applicable Essential Principles. Together the three form a complete closed loop of evidence, conclusion and commitment, and if any link is missing it will be challenged during review. Preparing these three elements as a deliberately consistent set, using the same terminology and the same evidence references, is the most efficient way to build a defensible submission.

Insight 2: the depth of technical documentation increases with class and complexity. Section 7.3 states explicitly that the range of evidence included in the technical documentation is expected to increase with the class of the device, its level of complexity and the extent to which it employs new technologies. This means that a Class I device and a Class IV device cannot be supported by an evidence package of the same depth. In practice, manufacturers should define the depth of each evidence element, from characterization data to clinical justification, according to the risk class and the novelty of the technology, and should record that scoping decision inside the dossier itself.

Insight 3: the EP checklist must contain written justifications for non-applicable items. When demonstrating conformity item by item, entries for principles that do not apply must not be left blank or marked N/A; a reason must be given. Leaving entries blank is one of the most common formal defects and will be read as an incomplete argument. A short but specific justification, for example explaining that the device has no software function and therefore the software-related principles are not applicable, converts a potential query into a closed point.

Insight 4: Essential Principles conformity extends beyond labelling and risk analysis to other national requirements. Section 7.3 lists: the technical documentation must provide evidence that the device conforms to the Essential Principles, labelling, risk analysis and other national regulatory requirements (for example, requirements applicable to radiation-emitting devices). Radiation-emitting devices therefore carry additional national requirements and cannot rely on the EP checklist alone. Manufacturers of such devices should identify the specific national requirements early and file the supporting evidence in the same dossier location as their EP evidence.

Insight 5: the technical documentation must include a declaration of truthfulness signed by the responsible person. Section 7.3 requires that the technical documentation submitted to the authority include a declaration that the content is true and accurate and identify the name, position and signature of the person authorized to submit the documentation on behalf of the manufacturer. This is a formal, accountable document, not a formatting page. Companies should therefore treat the signatory designation as a governance decision, confirm the authorization chain in writing, and ensure that the same authorized signatory appears consistently across the EP checklist, the DoC and the cover letter.

4. Practical recommendations

1. Build an evidence index item by item against the EP checklist: one principle maps to one or more evidence documents.
2. State reasons for non-applicable items: never leave them blank and never write N/A without justification.
3. Adjust the depth of evidence to the risk class and the degree of technological novelty: do not apply a single template to everything.
4. Provide supplementary evidence for device categories with special national requirements, such as radiation-emitting devices.
5. Attach the declaration of truthfulness and the responsible person’s signature to the front of the technical documentation.
6. Use the EP checklist as the master index of the dossier: it makes review and verification straightforward.

5. Verification checklist

• □ The Essential Principles checklist has been submitted in accordance with Section 3.2
• □ Applicability and the evidence index have been given item by item
• □ Written reasons have been provided for non-applicable items
• □ The depth of evidence has been adjusted to the risk class and the degree of technological novelty
• □ The technical documentation includes the declaration of truthfulness and the responsible person’s signature
• □ Special categories (such as radiation-emitting devices) have been supplemented with national requirement evidence

Regulatory information verified as of October 29, 2026. The Essential Principles requirements and checklist items listed in this article are based on the current text of EFDA/GDL/097 Section 3.2 and EFDA-GDL-046 Sections 7.3 and 9.2.5; when the guidelines are updated, they must be re-checked.

• Ethiopia local resource: GRZAN can assist manufacturers from the Chinese mainland and overseas with marketing authorization (MA), Certificate of Competency (CoC) and import licence applications to the Ethiopian Food and Drug Authority (EFDA), including local agent planning and agency agreement review, SRA reliance pathway justification, UMDN coding and classification determination, technical documentation 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 application and re-registration, applicability determination for the low-risk notification procedure, Essential Principles conformity justification, labelling and IFU localization (English), and vigilance reporting and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.