Egypt Special Import Requests: Types, Conditions and Document Requirements

1. Key takeaways

Beyond the regular import approval, Egypt operates a dedicated Special Import Requests Evaluation Unit covering six situations: devices donated to hospitals, imported by hospitals, imported by individuals for personal use, imported by physicians, imported by companies that do not trade in devices, and imported by companies dealing in devices and device imports on behalf of hospitals or patients. Procedurally, the request is submitted through MeDevice, with feedback of acceptance, rejection or suspension within 3 working days, completion requirements within a further 3 working days, suspension for 90 days leading to deemed refusal, and restoration within the following 90 days upon a one-time payment of the service fee.

The special import route is defined by who is importing and why, not by product risk. Donations above defined value thresholds require ministerial or Cabinet approval, hospitals must prove their eligibility to import, and individuals may import only new, case-appropriate, home-use devices. Research-protocol devices follow a separate channel under Section 4.3 and Appendix III, not the special import route.

2. Legal basis

3. Expert insights

Insight 1: the special import tracks are divided by who imports and why, not by product risk.

All six categories in Section 7.1 are defined by entity and purpose. The same product can follow entirely different channels depending on the importer: import by a distributor follows the regular import approval, while import by a hospital on its own behalf follows the special import route.

Insight 2: the approval level for donated imports is tied directly to the invoice value, with explicit thresholds.

Item 1 of Appendix VIII 8.8.1: a donation acceptance letter must be submitted, issued by the authorised body and signed and stamped by the chairman of the board of the body or facility (pursuant to Cabinet Resolution No. 1818/2019). Where the invoice value exceeds 1 million Egyptian pounds and does not exceed 10 million Egyptian pounds, the applicant’s request must include the approval of the competent minister or his delegate; where the value exceeds 10 million Egyptian pounds, the approval of the Council of Ministers must be obtained. This is one of the rare Egyptian import provisions that writes value thresholds directly into the guideline text.

Insight 3: donations and hospital imports both require at-your-own-responsibility declarations.

Item 2 of 8.8.1 and item 1 of 8.8.2 both require a signed and stamped declaration by the hospital or medical centre (signatures of non-government facilities must be authenticated), declaring that the imported devices will not be sold or traded, that the facility bears full responsibility, and that the EDA bears no responsibility. This converts the EDA’s risk isolation for devices imported through unregistered or special channels into a written document.

Insight 4: hospitals must prove their eligibility to import, failing which the case goes to the import committee.

Item 3 of 8.8.2: the commercial register of the hospital must be submitted (stating the import activity, or the applicability of Investment Law No. 8 of 1997 or No. 72 of 2017); where the register does not state the applicable investment law, a letter from the investment authority is submitted; where neither the import activity nor an applicable investment law is stated, the request is referred to the import committee. In addition, the licence of the hospital or medical centre issued by the non-government medical facilities and licensing department, and the basic activity list of the association or civil entity, must be submitted.

Insight 5: personal-use imports face three cumulative restrictions — new, case-appropriate, home-use.

8.8.3 provides: (1) items imported from abroad must be suitable for treating the case and must be new and unused; if the item is used, the applicant will be notified to apply to the import committee; (2) a clear medical report on the case must be submitted; (3) the imported product must be suitable for home use; where the case is under medical supervision, a letter from the treating physician must confirm full responsibility for using the device and undertake that it will not be used for other cases.

Insight 6: devices for research protocols follow a separate channel (Section 4.3 and Appendix III).

Section 4.3 of the guideline sets out a dedicated procedure for importing medical devices for research protocols, and Appendix III lists the required documents. This runs in parallel with the special import evaluation unit: companies importing devices for clinical trials or scientific research should use Appendix III, not Appendix VIII.

Insight 7: the 90 plus 90 gate applies to special imports as well.

Section 7.2.1: where documents and data required under Appendix VIII are not completed within 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. All three channels — import approval, annual plan and special import — share the same gate design.

4. Practical recommendations

1. Route by entity and purpose first: the six special import situations versus regular import versus the research protocol channel.
2. Compute the value tier for donation projects first: two approval thresholds at 1 million and 10 million Egyptian pounds.
3. Issue the donation acceptance letter under Cabinet Resolution No. 1818/2019: issued by the authorised body, signed and stamped by its chairman.
4. Prepare hospital eligibility evidence first: commercial register stating the import activity or an investment law applicability letter, failing which the case goes to the import committee.
5. Apply the three conditions for personal use strictly: new, case-appropriate and home-use; used items must go to the import committee.
6. Use Appendix III for research devices rather than mixing them into special import.
7. Run the same 90 plus 90 gate SOP as the other import channels.

5. Verification checklist

• □ The applicable category among the six special import situations has been determined, or the research protocol channel applies
• □ The approval tier for the donation has been determined by value (1 million / 10 million Egyptian pounds)
• □ The donation acceptance letter has been issued under Cabinet Resolution No. 1818/2019 and signed and stamped
• □ Declarations of no sale or trade, full responsibility and EDA non-liability have been issued
• □ The hospital licence, commercial register and activity list are ready
• □ For personal use, the device is confirmed as new and unused, suitable for the case and suitable for home use
• □ Reminders are set for the 90 plus 90 day suspension gate

Regulatory information verified as of 29 October 2026. The special import rules described here follow the current text of Section 7 and Appendix VIII 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.