Validity and Amendment of Egypt Import Approvals and Customs Release Rules

1. Key takeaways

Two operations around the Egyptian import approval are easily confused: issuance and amendment. Issuance (Section 4.1.4): once the dossier is complete, the import approval is issued and is valid for one year from the date of issuance. Amendment (Section 4.1.5): a request to amend the data of an import approval must be submitted on the MeDevice platform, stating the amendments required and uploading the documents supporting the request; where the amendment is made after issuance and does not affect the invoice value, the service fee is charged according to the decision issued by the EDA Chairman in this regard.

The annual import plan follows an identical design: Sections 5.4 and 5.5 give it the same one-year validity counted from issuance and the same amendment mechanism on the platform. Companies that internalise one set of rules for validity, amendment and supporting evidence can manage both instruments with a single procedure, while keeping amendment clearly separate from variations to the registration licence, which follow a different guideline.

2. Legal basis

3. Expert insights

Insight 1: the one-year validity runs from the date of issuance, not from the application date or the arrival date.

The wording of Section 4.1.4 is valid for one year from the date of issuance. When planning shipping schedules and customs declarations, companies should anchor everything to the issuance date, not to the contract date or the date of dispatch from the supplier.

Insight 2: amending data is not a fresh application, but it carries explicit evidentiary requirements.

Section 4.1.5 requires the amendment request to state the amendments required and to upload supporting documents. This differs from a variation: variations target the data of the registration licence (processed under GL.CAMD.003), whereas an amendment targets the data of the issued import approval itself — quantities, invoice information, device data — through the amendment procedure within the same import approval channel. Confusing the two leads to rejection as outside the remit of the department concerned.

Insight 3: not affecting the invoice value is the dividing line of the service fee clause.

The final sentence of Section 4.1.5 limits the service fee to amendments made after issuance without affecting the invoice value. This implies that amendments affecting the invoice value may trigger different fee or procedural treatment. (Practical estimate: the exact charging method follows the payment notice on the MeDevice platform and the current EDA Chairman decree.)

Insight 4: the annual import plan uses exactly the same validity and amendment mechanism.

Section 5.4: the annual import plan is valid for one year from the date of issuance. Section 5.5: a request to amend the annual plan must be submitted on MeDevice, stating the amendments and uploading supporting documents, and the amended plan is issued once the required documents are complete. The two mechanisms are symmetrical, and companies can manage them with the same internal SOP.

Insight 5: import approval and customs release are two successive stages and cannot substitute for each other.

Section 4.5 lists the release of devices holding an issued import approval as one of the six customs release situations. Appendix V (8.5.2) then lists the 10 documents required for release, including the (stamped) import approval previously obtained from the Central Administration for Marketing Authorisations together with the proforma invoice, the certificate of origin linked to the commercial invoice (where the invoice does not clearly state the origin), the free sale and quality certificate by classification (where the certificates in the import approval have expired or lapsed), and the registration licence matching the invoice items by number. Obtaining the import approval does not by itself secure release.

Insight 6: two undertakings are fixed features of the release stage.

Item 1 of Appendix V 8.5.2 requires an undertaking letter on the importing company’s letterhead, signed and stamped by the responsible manager, undertaking not to open the invoice before the presence of the inspectors of the Central Administration for Pharmaceutical Institutions Inspection. Item 1 of 8.5.1 (registration samples) instead requires an undertaking that the imported items are for registration purposes and will not be sold or traded, accompanied by a plan for submitting the registration dossier and an undertaking not to sell or trade and to bear legal responsibility. These two letters convert the rule that released goods may not be freely disposed of into a written company obligation.

Insight 7: where the original commercial invoice is missing there is a substitute, but it requires a written undertaking.

Appendix V notes that where the original commercial invoice has not been submitted, a written undertaking must be provided stating that the submitted invoice matches the original invoice submitted at the customs department and uploaded to the ACI system. This leaves a pathway open for electronic document flows.

4. Practical recommendations

1. Anchor shipping plans to the issuance date: validity is one year; work backwards for customs clearance and arrival.
2. Keep amendment and variation separate: data of the import approval follow the Section 4.1.5 amendment; data of the registration licence follow GL.CAMD.003 variations.
3. State the amendment fully in one request with supporting documents: description of amendments plus uploaded evidence.
4. Assess whether the amendment affects the invoice value: the answer determines the fee and procedural treatment.
5. Run the annual import plan on the same validity and amendment SOP.
6. Prepare the 10 release documents separately: stamped import approval, proforma invoice, certificate of origin, packing list, bill of lading and the licence matched by number.
7. Pre-draft both undertaking letters: no opening of the invoice, and no sale or trade.

5. Verification checklist

• □ The validity of the import approval (1 year from issuance) is on the register with an expiry reminder
• □ The amendment request has been submitted on MeDevice, stating the amendments and uploading supporting documents
• □ It has been assessed whether the amendment affects the invoice value
• □ The validity and amendment of the annual import plan are managed under Sections 5.4 / 5.5
• □ The 10 customs release documents are ready (stamped import approval, proforma invoice, certificate of origin included)
• □ The commercial invoice is stamped by the factory and states page order and the country of origin of each item
• □ Both undertaking letters (no opening of the invoice / no sale or trade) have been issued

Regulatory information verified as of 29 October 2026. The validity and amendment mechanisms described here follow the current text of Sections 4.1.4–4.1.5 and 5.4–5.5 and Appendix V 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.