Special Certificates for Export-Only Devices from Egyptian Local Factories

1. Key takeaways

Section 9 of the Egyptian variation guideline establishes a dedicated mechanism for the issuance of special certificates for export-only devices. The applicant must be a local factory, applying to the Central Administration; the fee is a technical support service fee of 2,000 Egyptian pounds; the output is a statement issued to the company specifying the export-only specifications; there are two types of statement — adding export-only codes and trade names for already registered devices, and designating countries or customers so that the Central Administration issues the statement of codes and names; and the red line is that codes and trade names added for export only are prohibited from circulating in the local Egyptian market.

The mechanism exists to resolve a practical pain point: export specifications often differ from the locally registered specifications. Rather than requiring separate registration, Egypt confirms the export-only specifications through a dedicated statement while explicitly prohibiting local circulation. The certificate also leaves the ownership of the registration licence untouched, so it can be combined with the existing licence-uniqueness rules without conflict.

2. Legal basis

3. Expert insights

Insight 1: the mechanism serves local factories only — it is the export-side companion of Egypt’s localisation policy.

Section 9.1 states expressly that the applicant is a local factory applying to the Central Administration. Importers do not qualify. This aligns with Egypt’s recent policy direction of promoting local manufacturing and positioning Egypt as a regional manufacturing and export base.

Insight 2: the certificate solves the mismatch between export specifications and locally registered specifications.

Many factories prepare codes and trade names for different export markets that differ from the Egyptian local registration (for example customer-branded products or different pack sizes). Egypt does not require these specifications to be registered separately; instead it issues a statement covering export-only specifications and simultaneously expressly prohibits their local circulation. It is a controlled treatment that sits outside the registration unit but remains regulated.

Insight 3: the difference between the two statement types lies in whether countries and customers are designated.

Section 9.2: (1) adding export-only codes and trade names for already registered devices; and (2) designating countries or customers so that the Central Administration issues the statement of codes and names. The second type is finer-grained — issued individually per country and customer.

Insight 4: the 2,000 Egyptian pounds is a technical support service fee and the only amount stated in this provision.

Section 9.1: a payment of 2,000 L.E. is made for technical support services. This is one of the few service fees stated as a figure anywhere in the EDREX guidelines (the other being the 2,000 L.E. for the case study). (Practical estimate: whether the amount is adjusted follows the current guideline and EDA Chairman decrees.)

Insight 5: the prohibition of local circulation is a market-conduct red line, not a drafting formality.

The final sentence of Section 9.2: codes and trade names added for export only are prohibited from circulating in the Egyptian local market. Factories must therefore hard-separate export specifications from local specifications in their internal order and shipping systems; if an export-only specification reaches the local market, it is there in an unregistered state.

Insight 6: the mechanism dovetails with the uniqueness rule for the original registration licence.

Section 11.4 of GL.CAMD.002: the original registration licence belongs to its owner, and copies held by any other agent or distributor are not considered. The export-only certificate does not change the ownership of the registration licence and does not create a second licence holder — it only attaches export specification statements on top of the existing licence.

Insight 7: the mechanism stacks effectively with the simplification policy for local factories holding CE.

Together with the EDA announcement of 16 April 2026 (local factories holding CE are exempted from submitting a reference-country FSC, stability studies and biocompatibility reports), local factories in Egypt now benefit from both simplification on the registration side and a dedicated channel on the export side. (Practical estimate: the scope and implementing details of that announcement follow the current notice text on the EDA website.)

4. Practical recommendations

1. Confirm eligibility first: only local factories may apply for the export-only certificate.
2. Budget the 2,000 L.E. technical support service fee and verify its current validity.
3. Choose the statement type by need: adding codes and trade names only, or country- and customer-specific statements issued individually.
4. Hard-separate export specifications from local specifications in order and shipping systems.
5. Keep export-only specifications out of local channels: establish flow-direction checks.
6. Evaluate together with the CE simplification policy: local factories holding CE benefit on both the registration and export sides.
7. Remember the certificate does not change licence ownership: manage under the original-uniqueness rule.

5. Verification checklist

• □ The applicant is a local factory
• □ The application has been submitted to the Central Administration
• □ The technical support service fee of 2,000 L.E. has been paid
• □ The statement type has been selected (adding codes and trade names / designated countries and customers)
• □ Export and local specifications are hard-separated in the systems
• □ Flow-direction checks ensure export specifications do not enter the local market
• □ The ownership of the original registration licence is unaffected

Regulatory information verified as of 29 October 2026. The export-only certificate mechanism described here follows the current text of Sections 9.1 and 9.2 of EDREX: GL.CAMD.003 Version 3.

• 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.