Egypt Reference Countries List for Medical Device Registration

1. Key takeaways

Egypt divides the world’s countries into reference countries and non-reference countries. Section 2 of EDREX: GL.CAMD.002 lists 37 reference countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Croatia, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Lithuania, Liechtenstein, Luxembourg, Malta, the Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, and the United States. China is not on the list. This status carries two additional burdens: the product must first undergo dedicated Scientific Committee evaluation, and a free sale certificate (FSC) from a reference country must be submitted. The reference-country concept thus operates as the gateway that shapes the entire registration pathway for any manufacturer outside the listed markets, and it should be the first question answered in every Egypt feasibility assessment.

2. Legal basis

3. Expert insights

Insight 1: the reference-country list is in substance a trust list, not a mutual recognition agreement.

The composition is dominated by European Union member states, supplemented by Australia, Canada, Iceland, Japan, Liechtenstein, New Zealand, Norway, Switzerland, the United Kingdom, and the United States. The EDA accepts certificates issued by the competent authorities of these countries, but it does not require those countries to recognize Egyptian decisions in return. The pathway is therefore one of unilateral reliance: the value of a reference-country approval flows into Egypt, but nothing flows back. Companies should not spend regulatory capital seeking reciprocal arrangements that the framework never contemplates, and they should instead concentrate on obtaining approvals from authorities on the list.

Insight 2: non-reference-country status creates two extra checkpoints, one at registration and one at import.

At the registration stage, Section 5 of GL.CAMD.002 provides that devices imported from non-reference countries or locally produced, submitted for new registration or re-registration, must undergo dedicated Scientific Committee evaluation. At the import stage, Class IIb and III devices whose country of origin is not a reference country must pass Scientific Committee evaluation before an import approval can be obtained, and a reference-country FSC must be submitted. Both checkpoints consume time that no expedited paperwork can recover, so they belong in the master schedule as fixed stages rather than as contingencies.

Insight 3: the reference-country FSC is an unavoidable evidence-gathering action.

The guideline frames the FSC requirement as follows: the FSC of the country of origin of the manufacturing site must be submitted, stating the trade name and code; if the manufacturing country is not a reference country, an FSC from a reference country must be submitted; and in the absence of CE marking or FDA approval, the origin-country FSC plus the FSC of any one reference country is required. For manufacturers in China this means that even with NMPA approval in hand, an FSC from a reference-country market is still needed. Sequencing that FSC application early, in parallel with the Egyptian planning, is the single most effective way to shorten the total timeline.

Insight 4: certificate validity is quantified as at least 3 months, or 5 years in the defined scenario.

The guideline provides that submitted certificates must remain valid for at least 3 months from the date of submission, and that in the scenario without CE marking or FDA approval, the FSC must state an expiry date or carry a 5-year validity. Expired or near-expiry certificates are among the most common reasons dossiers are returned. A certificate expiry early-warning system, tied to the planned submission date rather than to the calendar alone, removes this failure mode almost entirely.

Insight 5: the list is dynamic, and the current guideline always prevails.

While issuing the list, the guideline does not close its scope, and in practice the list published in the current EDREX guideline is the controlling version. Copying a reference-country list from experience in other jurisdictions carries real version risk: a country added or removed in the current Egyptian list changes the certificate strategy entirely. The list check should therefore be repeated before every submission, not once per project.

4. Practical recommendations

1. Determine reference-country status first: confirm whether the manufacturing country and the country of origin appear on the 37-country list as currently published.
2. Plan the reference-country FSC early for Chinese manufacturers: obtain the FSC through market access in reference markets such as the European Union, the United States, the United Kingdom, Canada, Japan, or Australia.
3. Include Scientific Committee evaluation in the total timeline: new registrations and re-registrations of non-reference-country imports generally go to committee, so reserve a dedicated window in the schedule.
4. Keep a 3-month validity margin on certificates: operate a certificate expiry early-warning process so no certificate falls below the minimum remaining validity at submission.
5. Re-check the list before every submission: the reference-country list published in the current EDREX guideline is the only controlling version.

5. Verification checklist

• □ Confirmed whether the manufacturing country and country of origin are reference countries (current list)
• □ Obtained the origin-country FSC stating the trade name and code
• □ Where the manufacturing country is not a reference country, obtained a reference-country FSC
• □ Confirmed all certificates remain valid for at least 3 months from the submission date
• □ Reserved time for Scientific Committee evaluation
• □ Re-checked the reference-country list against the current guideline

Regulatory information verified as of October 29, 2026. The reference-country list described in this article follows the current text of Section 2 of EDREX: GL.CAMD.002 Version 2 (September 2025); when the list is adjusted, the content must be re-checked.

• Local Egypt support: GRZAN assists manufacturers from the Chinese mainland and overseas with medical device registration, import approval, and change applications before the Egyptian Drug Authority (EDA), including design of the registration applicant structure (importing company, local factory, or scientific office), preparation for Scientific Committee evaluation, advisory work on pathways for obtaining free sale certificates from reference countries, Arabic localization of labels and instructions for use, and the build-out of vigilance systems and periodic reporting.
• Service capabilities: product characterization and risk classification (devices Class I–III and IVDs Class A–D), registration and re-registration, determination of applicability of system registration and group registration, three-category determination of changes, import approval and annual import plans, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.