Egypt Import Approval Procedure, Suspension and Restoration under GL.CAMD.007

1. Key takeaways

The procedure for import approval in Egypt is shorter and sharper than registration. Under the regulatory guideline for issuing import approvals for various medical devices, EDREX: GL.CAMD.007 Version 2, the sequence is: acceptance — feedback of acceptance, rejection or suspension for completion within 2 working days of sending the request, through MeDevice; evaluation — requirements for completion issued on the platform within 3 working days of receiving the dossier; completion — carried out on the MeDevice platform; and issuance — the import approval is issued once complete, valid for one year from the date of issuance. The suspension rule works as follows: if the documents are not completed within 90 days of the issuance of the completion requirements, the review stops and the application is deemed refused; it may be restored within the following 90 days under the same previous application number and upon a one-time payment of the service fee, failing which the application lapses.

Because every clock in this procedure runs in days rather than months, companies must arrive at the platform with fully formed documents. The procedure leaves almost no room for assembling evidence while the review is under way, and the suspension-restoration mechanism is the only safety valve once a deadline is missed.

2. Legal basis

3. Expert insights

Insight 1: every clock in the import approval runs at day level — faster and tighter than registration.

Acceptance within 2 working days and evaluation within 3 working days are both far shorter than the 5 / 20 working days of the registration procedure. This means companies have almost no buffer at the Egyptian import stage: documents must be fully formed in advance, because the review cannot proceed while evidence is still being assembled.

Insight 2: the suspension rule is a two-gate structure of 90 plus 90 days, and the second gate costs money.

The first gate: if the documents are not completed within 90 days of the issuance of the completion requirements, the review stops and the application is deemed refused. The second gate: the procedure 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. Note that the service fee at the second gate is charged only once — a second lapse on the same application leaves no third chance.

Insight 3: rejection grounds closely mirror the registration stage and concentrate on data consistency.

Section 4.1.1 provides that an application will be rejected where any data required in the company’s application does not match the receipt, or where the application does not fall within the remit of the department to which the request was directed. This wording is almost identical to the rejection clause in the registration procedure. Administrative-consistency defects are the leading killer of both application types in Egypt.

Insight 4: payment is step zero, and its legal basis is explicit.

Item 1 of Section 4.1.1: the company applies through medevice.edaegypt.gov.eg, and fees are charged according to the fee item categories set out in Prime Minister’s Decision No. 777/2020 (the executive regulation of the law establishing the EDA). (Practical estimate: the service fee is charged according to the decision issued by the EDA Chairman in this regard, and the exact amount follows the payment notice on the platform.)

Insight 5: the same 90 plus 90 structure also applies to annual import plans and special imports.

Section 5 (annual import plans) and Section 7 (special imports) adopt the same structure: a 3 working day response, a 3 working day evaluation, a 90 day suspension, and restoration within 90 days upon a one-time payment of the service fee. This shows the structure is the generic gate design of the EDA platform, not something unique to import approvals.

Insight 6: the platform is the only entry point, with no offline alternative.

All three stages are expressly completed through medevice.edaegypt.gov.eg, and completion of documents also takes place on the platform. Companies therefore need a local representative in Egypt capable of operating the platform, whose signature must be authenticated by the bank (item 1 of Section 8.1.1).

Insight 7: the import approval is valid for one year — a sharp contrast with the ten-year registration licence.

Section 4.1.4 provides that the import approval is valid for one year from the date of issuance. The consequence is that the registration licence lasts ten years, but every import requires an import approval that is within one year of issue. The two documents are parallel and both must be maintained; registration is not a one-off exercise that secures ten trouble-free years.

4. Practical recommendations

1. Submit only after the documents are fully formed: response windows of 2 and 3 working days do not allow assembly during review.
2. Set a hard 90-day reminder counted from the issuance of the completion requirements; beyond it the application is deemed refused.
3. Use the second 90-day window after a lapse: restore under the same application number with a one-time service fee.
4. Verify application data against the payment receipt verbatim: any mismatch means rejection.
5. Confirm the competent department first: mis-routed applications are rejected outright.
6. Ensure the local representative is bank-authenticated and capable of operating the platform.
7. Maintain the import approval annually: with a one-year validity it must be scheduled separately from the ten-year registration licence.

5. Verification checklist

• □ The application has been submitted and paid through medevice.edaegypt.gov.eg
• □ Acceptance feedback has been tracked against the 2 working day limit
• □ Evaluation and completion requirements have been tracked against the 3 working day limit
• □ An internal reminder is set for the 90 day suspension deadline
• □ The second 90 day window and the one-time service fee for restoration have been planned
• □ Application data has been verified verbatim against the payment receipt
• □ The competent department for the application has been confirmed
• □ The one-year validity of the import approval is included in the annual maintenance plan

Regulatory information verified as of 29 October 2026. The import approval procedure described here follows the current text of Sections 4.1.1–4.1.4 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.