Two Registration Routes for Locally Manufactured Medical Devices in Egypt

1. Key takeaways

Egypt treats locally manufactured devices through two pathways divided by the question of whether the factory holds an international quality certificate. Factories holding the certificate follow Section 4.2.2 of EDREX: GL.CAMD.002: they have a 2-year rectification period from the date of publication of the guide to complete registration, with the initial dossier due in the first 6 months and the remaining documents due within the following 18 months; after the final acceptance number is obtained, a 1-year import grace period applies. Factories without the certificate follow EDREX: GL.CAMD.09: acceptance within 10 working days, issuance of a correction request within 20 working days, and assessment of the correction within 10 working days, with the inspection department additionally involved in sampling and testing of the trial production batch.

2. Legal basis

3. Expert insights

Insight one: the dividing line between the two pathways is the international quality certificate, not the risk class of the product.

Egypt’s regulatory logic for local production treats the quality certificate as the anchor of trust: with a certificate, the factory follows a simplified procedure; without one, it faces full technical review and sampling and testing. This differs from the mainstream practice of other markets, where the pathway is divided by classification, and it is a direct expression of Egypt’s localization policy. For a factory deciding where to invest first, the implication is that obtaining an acceptable quality certificate unlocks a materially lighter procedural burden than any adjustment of product risk class would.

Insight two: the 2-year rectification period of Section 4.2.2 is a policy buffer for existing factories, and trading may continue while it runs.

The guide states expressly that factories have a 2-year rectification period from the date of publication of the guide to complete the registration procedure; during the rectification period, trading remains the responsibility of the factory and continues under the practice in place before publication of the guide; but the initial dossier must be submitted within the first 6 months. This arrangement allows local factories to complete compliance without interrupting their operations, and it is a deliberate transition design for the entry into force of the new rules. Missing the 6-month node, however, forfeits the protection of the rectification period.

Insight three: the initial dossier for the local pathway is looser than for the imported pathway, since the FSC is required only if available.

Section 4.2.2 requires for the initial dossier: the DoC, the CE certificate, ISO 13485:2016, and the reference-country FSC, if available. Compared with Section 4.2.1, which makes the reference-country FSC mandatory for imported Class IIb and III devices, the local pathway treats this item as a soft requirement. A local factory without any reference-country marketing history can therefore enter the system, but it must compensate with the stability and biocompatibility obligations described below.

Insight four: the local pathway additionally carries the requirements of the stability and biocompatibility committee.

The first submission category of Section 6 makes clear that devices that are locally manufactured and have no transactions in any reference country (that is, no reference-country FSC and no FDA 510(k)) must, at registration and re-registration, be submitted to the dedicated scientific committee for stability and biocompatibility studies, together with a real-time stability study. The study samples must be sealed by the Central Administration for Inspection of Pharmaceutical Institutions, stamped by the entity that conducted the study (the factory or an accredited laboratory), and retained at the factory for the validity period of the registration license. This is the heaviest compliance cost of the local pathway.

Insight five: the announcement of 16 April 2026 opened a simplified channel for local factories holding CE.

The EDA announced on 16 April 2026 that local factories holding CE certificates, when submitting registration or re-registration dossiers, are exempt from submitting the reference-country FSC, the stability studies and the biocompatibility test reports, while the EDA retains the right to request them. This means that the combination of local production with a CE certificate has become the most advantageous position currently available in Egypt. (Practical estimate: the scope of application and the execution details of the announcement must follow the original text of the current announcement on the EDA website.)

Insight six: when the grace period ends, what is cut off is the import of raw materials, not finished products.

The closing sentence of Section 4.2.2 states that after the granted period ends, the import of raw materials, components and inputs used in production will no longer be allowed. The constraint therefore lands on the upstream of the supply chain, and it hits hardest at local factories that depend on imported raw materials. Local sourcing plans must be prepared well before the deadline, since building alternative supplier relationships typically takes longer than the regulatory paperwork itself.

4. Practical recommendations

1. Determine the certificate status before choosing the pathway: factories holding a CE or international quality certificate follow Section 4.2.2; those without follow GL.CAMD.09.
2. Existing factories should act early within the 2-year rectification period: the initial dossier must be filed in the first 6 months, or the protection of the rectification period is lost.
3. Prioritize obtaining CE for local production: with CE, the three exemptions of the announcement of 16 April 2026 become available.
4. Design the stability study to the sealing requirements: samples sealed by the inspection department, stamped by the study entity, from the same batch numbers as the study, and retained until the end of the validity of the registration license.
5. Prepare documentation on the 10/20/10 working-day rhythm of GL.CAMD.09: all three nodes are short, so the documents must be fully formed in advance.
6. Synchronize the schedule across the supply chain: the end of the grace period cuts off imports of raw materials and components, so a localization sourcing plan must be prepared ahead of time.

5. Verification checklist

• □ It has been determined whether the factory holds an international quality certificate, and the Section 4.2.2 or GL.CAMD.09 pathway has been selected
• □ Existing factories have submitted the initial dossier within the first 6 months
• □ The 18-month completion period and the 1-year import grace period have been scheduled
• □ The four items of the initial dossier (DoC, CE, ISO 13485:2016, FSC if available) are in place
• □ Stability study samples meet the four requirements of sealing, stamping, same batch numbers and long-term retention
• □ The applicability of the CE simplification measures of the announcement of 2026-04-16 has been assessed
• □ A localization sourcing plan for raw materials and components has been evaluated

Legal information verified as of 29 October 2026. The local production pathways described in this article follow the current text of Sections 4.2.2 and 6 of EDREX: GL.CAMD.002 Version 2 and of EDREX: GL.CAMD.09 Version 2; the simplification measures of 16 April 2026 follow the original text of the announcement on the EDA website.

• Egypt local resources: 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 arrangement (importing company, local factory or scientific office), preparation for scientific committee assessment, argumentation of routes for obtaining free sale certificates from reference countries, Arabic localization of labels and instructions for use, and the establishment 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 determination for system registration and bundled 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.