Egypt Import Approval Types and Appendices I-X under EDREX GL.CAMD.007

1. Key takeaways

Import approval in Egypt is not a single channel but a set of parallel tracks assigned by situation. Under EDREX: GL.CAMD.007 Version 2 (September 2025), Section 8 identifies six routes: (1) registered devices (Appendix I); (2) devices used in medical activities (Appendix II); (3) devices for research protocols (Appendix III); (4) production inputs, components and raw materials for local device factories (Appendix IV); (5) annual import plans (Appendix VI) and customs release (Appendix V); and (6) special import requests (Appendix VIII). Three supporting appendices complete the framework: Appendix VII for documents submitted to the specialised scientific committee, Appendix IX for the letter of lack of jurisdiction, and Appendix X for quality and sale certificates by classification.

The routing decision comes first because a mis-routed application is rejected outright as outside the remit of the department concerned. Companies should map each consignment to the correct appendix before assembling any dossier, since document sets differ substantially across routes.

2. Legal basis

3. Expert insights

Insight 1: nearly half of the Appendix I document set is administrative-consistency paperwork.

Appendix I (import of registered devices) requires, among other items: a power of attorney from the importing company to the contact person (signed and stamped by the manager, signature authenticated by the bank); a payment receipt bearing the invoice number and stamped by the Authority; the proforma invoice; the medical device importer registration licence; Form-14 (c14) where the registration licence names an agent; a distribution or agency contract authenticated by the chamber of commerce and the Egyptian embassy where the licence mentions the agent or is marked as covering part of the products; a letter explaining the manufacturer–supplier relationship where these differ (including the supplier’s right to supply Egypt), likewise authenticated; and a valid registration notification issued by the Registration Directorate. None of these documents proves product safety; they prove the consistency between the applicant entity and the registration licence.

Insight 2: data mismatches have a dedicated pathway in Egypt rather than outright rejection.

Item 12 of Appendix I provides that where a registered device has changed — that is, any discrepancy exists between the data in the registration notification and the device data stated on the invoice — the applicant submits either a letter issued by the Variation Department of the Registration Directorate concerning the registration notification, or the initial acceptance number of a variation application filed with the Registration Directorate. In practice a company can first open a variation case, obtain the initial acceptance number, then continue with the import approval.

Insight 3: two clarification-letter provisions show that Egypt tolerates minor discrepancies.

Item 13 of Appendix I covers different postal codes in the certificate: the applicant submits a clarification letter from the manufacturer explaining that certain digits in the address reflect a change of postal code. Item 14 covers situations where, after comparing the registration notification, the invoice and the renewed quality certificate, certain data remain unclear: the applicant submits the manufacturer’s catalogue (leaflet) explaining the product’s intended use, model and code. Item 15 covers cases that remain unclear even then: a Declaration Certificate must be submitted, containing at least the address of a given manufacturer and the product classification. Together these form a tiered mechanism for handling discrepancies.

Insight 4: expired certificates create a supplementary submission duty at the import stage.

Item 16 of Appendix I requires submission of the certificate of sale and quality (FSC plus CE or FDA) stated in the registration notification where it has expired or lapsed. This is the link between registration and import: even if the registration licence itself remains valid, an expired certificate will still block the consignment at the import stage.

Insight 5: the document list for non-sterile devices differs from that for sterile devices, dropping several items but adding a catalogue requirement.

The list titled “documents required for import approval of non-sterile devices” (8.1.2), which follows Appendix I, requires — in addition to the power of attorney, proforma invoice, importer registration licence, Form-14, agency contract and payment receipt — the manufacturer’s catalogue, stating the devices it contains, their conformity (model or code) and the intended use; where the catalogue does not explain how to use the device, a manufacturer letter stating the intended use must be submitted instead. It also requires the trade and quality certificate by classification (Appendix X).

Insight 6: dosage-form and dental devices face additional requirements at the import stage.

Item 15 of the non-sterile list provides that dosage-form devices must be forwarded, together with the documents above (by classification), to the specialised scientific committee to obtain the import approval; item 16 requires dental devices to be accompanied by additional documents. In addition, items 4–5 of Appendix I specifically address the repair and refurbishment of cochlear implants: the invoice at the time of export and the repair and refurbishment report must be submitted.

Insight 7: the letter of lack of jurisdiction (Appendix IX) is an easily overlooked pathway.

Appendix IX lists the documents required to issue a letter of lack of jurisdiction. Read with the EDA guidance to applicants of June 2025 (Cases where Pharmaceutical and Biological Product Manufacturers must approach CAMD to obtain an Import Approval or a Non-Jurisdiction statement), this pathway determines whether a product falls within device jurisdiction — critical for drug-device combinations and borderline products.

4. Practical recommendations

1. Determine the situation first, then select the appendix: the six situations map to different appendices, and a wrong selection is rejected as outside the department’s remit.
2. Prepare the administrative-consistency documents first: bank-authenticated power of attorney, payment receipt stamped with the invoice number, importer registration licence.
3. Open a variation case first where discrepancies exist: obtain the initial acceptance number before continuing the import approval.
4. Use the three-tier clarification mechanism: a clarification letter for postal-code differences, the catalogue for unclear data, and the Declaration Certificate where doubt remains.
5. Maintain a certificate-expiry register: an expired FSC, CE or FDA certificate cited in the registration notification will block import.
6. Always submit the manufacturer’s catalogue for non-sterile devices: add a letter stating the intended use where the catalogue is silent on method of use.
7. Allow committee time for dosage-form and dental devices; approach the lack-of-jurisdiction pathway early for borderline products.

5. Verification checklist

• □ The import approval type has been determined and the corresponding appendix selected (I–VIII)
• □ The power of attorney is signed and stamped by the manager with the signature authenticated by the bank
• □ The payment receipt bears the invoice number and the Authority’s stamp
• □ The medical device importer registration licence is valid; Form-14 is prepared where an agency applies
• □ The distribution or agency contract is authenticated by the chamber of commerce and the Egyptian embassy
• □ Where the manufacturer and the supplier differ, the relationship letter is authenticated and states the right to supply Egypt
• □ A valid registration notification or an initial acceptance number is available
• □ The trade and quality certificate by classification (Appendix X) is within its validity period

Regulatory information verified as of 29 October 2026. The import approval types and appendix structure described here follow the current text of Section 8 and Appendices I–X of EDREX: GL.CAMD.007 Version 2.

• Local resource in Egypt: GRZAN assists manufacturers from the Chinese mainland and other overseas markets in engaging the Egyptian Drug Authority (EDA) for medical device registration, import approvals and variation applications, including design of the registration applicant scheme (importing company, local factory or scientific office), preparation for scientific committee evaluation, analysis of pathways for obtaining free sale certificates from reference countries, Arabic localisation of labels and instructions for use, and setup of vigilance systems and periodic reporting.
• Service capabilities: product attribute determination and risk classification (devices Class I–III / IVD Class A–D), registration and re-registration, applicability assessment of system registration and bundled registration, three-category variation determination, import approvals and annual import plans, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; info@grzanglobal.com; website www.grzan.cn.