Registration Route for Sterile Medical Devices in Egypt

1. Key takeaways

For sterile medical devices holding international quality certificates, whether imported or locally manufactured, Egypt applies the unified procedure of Section 4.1 of EDREX: GL.CAMD.002: pay the fees and have the device name added and the routing fixed, submit on the platform, obtain acceptance, undergo verification against the checklist, then assessment along four parallel lines (the scientific committee, the medical device vigilance department, the stability committee, and the regulatory assessment covering technical file review and certificate verification), then issuance of a correction request, then correction by the company, then evaluation by the technical committee or the central administration, and finally issuance of the registration license. Compared with the non-sterile pathway, the sterile pathway has no initial dossier plus 18-month deferred submission mechanism: the complete dossier must be submitted in one pass in accordance with the checklist of Annex 1.

2. Legal basis

3. Expert insights

Insight one: sterile and non-sterile devices follow two different procedures in Egypt, not simply files of different thickness.

The guide divides Section 4 into 4.1 for sterile devices and 4.2 for non-sterile devices, and the two sections carry different workflow diagrams: workflow no.1 corresponds to sterile devices with a complete dossier, while workflow no.2 corresponds to the initial dossier route for non-sterile devices. There is no deferred-submission channel after initial acceptance for sterile devices. This means that once a sterile product arrives with an incomplete dossier, the only remaining path is the suspension-for-correction route with its ceiling of 90 working days, after which the application is deemed withdrawn. The sterile classification is therefore not a label to be applied lightly or corrected later.

Insight two: assessment runs on four parallel lines, and any one of them can independently generate a correction request.

The workflow diagram identifies the assessing bodies as the scientific committee, the vigilance department (corresponding to the device safety procedures of Section 8), the stability committee, and the regulatory assessment function covering technical file review and certificate verification. Companies habitually concentrate their attention on the technical file and overlook the fact that the vigilance line and the stability line each issue their own requirements. At the registration stage the safety declaration form (Annex 6) is already submitted, and the safety department’s opinion is part of the flow. (Practical estimate: the specific form numbers and routing details follow the current annexes of the guide.)

Insight three: the certificate combination for sterile products is stricter than for non-sterile ones.

Under Annex X of GL.CAMD.007, Class I sterile devices require a Declaration of Conformity (DoC) plus a Free Sale Certificate (FSC), whereas Class I non-sterile devices may rely on the DoC or the FSC, at the company’s choice. This one-word difference determines the volume of preparation for many low-value consumables: once a product is judged to be sterile, the DoC alone is no longer a sufficient condition. Companies marketing the same product line in both configurations must therefore maintain two distinct certificate sets and must not assume that one file can serve both.

Insight four: sterilization information runs through registration, change and re-registration alike.

Section 6 requires that all studies relating to sensitization and irritation testing state clearly the sterilization method of the device. The change guide lists the addition or change of a sterilization method among matters that must be assessed before implementation. At re-registration, where the sterilization method has changed, a new stability study must be submitted and the biological risk re-evaluated. In other words, the sterilization method is a field that the Egyptian authorities ask about repeatedly, and it must be fixed at registration and kept consistent with the certificates throughout the life cycle of the license.

Insight five: the sterile routing decision must be completed before submission and must agree with the payment receipt.

Among the three grounds of rejection at the acceptance stage is the situation where the application does not fall within the competence of the department concerned. Sterile versus non-sterile status is one of the key dimensions of that routing judgment, and an error in it terminates the application outright. The routing stated on the payment receipt and the actual attributes of the dossier must therefore be reconciled before the file goes in, not after a rejection letter arrives.

4. Practical recommendations

1. Fix the sterile attribute before submission: confirm the routing with the evaluating pharmacist at the payment and name-entry stage, so that rejection on competence grounds is avoided.
2. Assemble the complete dossier against Annex 1 in one pass: the sterile pathway has no 18-month buffer, so a phased-submission strategy must not be planned.
3. Rehearse each of the four assessment lines separately: check the technical file, the certificates, the vigilance documents (including the safety declaration) and the stability and biocompatibility data one by one.
4. Verify the certificate combination against the classification: Class I sterile requires DoC plus FSC; Class IIa requires DoC plus FSC plus CE, together with ISO 13485:2016.
5. Keep the sterilization method field globally uniform: the sterilization method stated in the DoC, the CE certificate, the FSC, the technical file and the labels must be identical.
6. Prepare the vigilance documents in advance: the safety declaration form and the undertaking letter may generate requirements as early as the acceptance stage.

5. Verification checklist

• □ The sterile attribute of the product has been determined and agrees with the routing on the payment receipt
• □ The complete registration dossier has been assembled against Annex 1 (no initial-dossier buffer)
• □ Documentation for all four lines (scientific committee, vigilance, stability, regulatory assessment) has been prepared
• □ The certificate combination has been checked against Annex X (Class I sterile = DoC plus FSC)
• □ The ISO 13485:2016 certificate is valid and covers the actual manufacturer
• □ The sterilization method is stated consistently across all documents
• □ The safety declaration form (Annex 6) and the vigilance undertaking letter are in place

Legal information verified as of 29 October 2026. The sterile device registration procedure described in this article follows the current text of Section 4.1 and Annex 1 of EDREX: GL.CAMD.002 Version 2; the certificate combinations follow Annex X of EDREX: GL.CAMD.007 Version 2.

• 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.