Egypt Annual Import Plan and Customs Release Procedures Explained

1. Key takeaways

Egypt provides a dedicated annual import plan channel for high-frequency importers. The plan is submitted through MeDevice, handled by the Medical Devices Import Plans Unit, with feedback of acceptance, rejection or suspension for completion within 3 working days, completion requirements issued within a further 3 working days, issuance once the dossier is complete and validity of one year from the date of issuance; amendments must be submitted on the platform with supporting documents. Customs release (Section 4.5 and Appendix V) covers six situations, of which the three most relevant to routine trade are registration samples, devices holding an import approval and devices holding an annual import plan.

The annual plan converts batch-by-batch applications into a single yearly exercise, but it demands a heavier dossier at the outset, and the plan itself expires after one year and must be renewed annually. Companies should therefore decide between per-batch import approvals and the annual plan based on import frequency and product stability, and should keep the customs release document set under separate control because approval and release remain distinct stages.

2. Legal basis

3. Expert insights

Insight 1: the value of the annual plan lies in turning repeated applications into one application used all year.

For companies with many import batches per year, the annual plan can significantly reduce the number of applications. The price is a larger document set at the application stage — the full-year plan materials required under Appendix VI — and the fact that the plan itself is valid for only one year and must be rebuilt every year.

Insight 2: the annual plan shares the same 90 plus 90 suspension gate as the import approval.

Section 5.1: where documents and data required under Appendix VI are not completed for 90 days, the review stops and the application is deemed refused; it may be restored within the following 90 days under the same application number and upon a one-time payment of the service fee, otherwise the application lapses. This is identical to Section 4.1.1 for import approvals.

Insight 3: customs release is a separate stage and is conditional on medical customs clearance.

Section 4.5: the release of devices holding an issued import approval (invoice by invoice or under the annual plan) is conditional on the medical customs clearance, and includes six situations: import approval for registered medical devices, registration samples, raw material analysis samples, import approvals obtained from the approval departments, devices holding an annual import plan, and the Intragastric balloon.

Insight 4: the document structures of the three release situations are similar, but the undertakings differ.

The three situations in Appendix V (8.5.1 registration samples, 8.5.2 import approval, 8.5.3 annual import plan) share the following documents: an undertaking letter on the importing company’s letterhead signed and stamped by the responsible manager; a power of attorney to the contact person at the Central Administration for Marketing Authorisations (signature authenticated by the bank); the commercial invoice stamped by the factory (stating page order and the country of origin of each item); the plan for submitting the registration dossier and the undertaking not to sell or trade and to bear legal responsibility; the packing list accompanying the goods; and the bill of lading linked to the commercial invoice. The differences: 8.5.2 additionally requires the stamped import approval plus the proforma invoice, the certificate of origin (where the invoice does not state the origin), the registration licence matching the invoice items by number, and the free sale and quality certificate where the certificates in the import approval have expired or lapsed; the undertaking in 8.5.1 instead states use for registration purposes and no sale or trade.

Insight 5: the undertaking not to open the invoice is a substantive constraint.

Item 1 of both 8.5.2 and 8.5.3 requires the undertaking that the invoice will not be opened before the presence of the inspectors of the Central Administration for Pharmaceutical Institutions Inspection. Physical handling of the goods after arrival is thus under regulatory control, and companies must align with the inspection arrangements.

Insight 6: certificate validity must be re-checked even at the release stage.

Item 10 of 8.5.2 requires resubmission by classification where the free sale and quality certificates in the import approval have expired or lapsed. In other words, even with an import approval in hand, expired certificates must be made good before release.

Insight 7: the eligible applicants and device categories for the annual plan are governed by dedicated notices.

The EDA notice-to-applicant section carries the August 2024 notice on updating the categories of medical devices allowed for obtaining annual importation plans, and the March 2025 notice on updating the applicable procedures for issuing annual plans for registered medical devices and submitting a request for change, re-registration or new registration. (Practical estimate: the device categories eligible for annual plans follow the current EDA notices; specific categories are not listed here.)

4. Practical recommendations

1. Assess whether the annual plan fits: prioritise high-batch, stable product lines; first check the current notice on eligible categories.
2. Assemble the full-year dossier in one pass under Appendix VI: the annual plan requires more material than a single-batch application.
3. Manage it with the same 90 plus 90 gate SOP as the import approval.
4. Tabulate release documents by the three situations: six shared items plus the situation-specific items.
5. Pre-draft the undertaking letters before arrival: no opening of the invoice, and no sale or trade.
6. Re-check certificate validity before release: expired certificates cited in the import approval must be resubmitted.
7. Rebuild the annual plan each year: one-year validity, linked to the certificate-expiry register.

5. Verification checklist

• □ The product has been confirmed as falling within the current categories eligible for an annual import plan
• □ The annual plan dossier is complete under Appendix VI and submitted through MeDevice
• □ The 3 working day acceptance and 3 working day evaluation milestones are being tracked
• □ Reminders are set for the 90 plus 90 day suspension gate
• □ The validity of the annual plan (1 year) is included in annual maintenance
• □ The customs release situation has been determined (registration samples / import approval / annual plan)
• □ The 6 shared documents and the situation-specific documents are ready
• □ Certificate validity has been re-checked before release

Regulatory information verified as of 29 October 2026. The annual import plan and customs release rules described here follow the current text of Sections 4.5 and 5.1–5.5 and Appendices V and VI of EDREX: GL.CAMD.007 Version 2; device categories eligible for annual plans follow the current EDA notices.

• 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.