Legal Basis of EDA Medical Device Fees under Decision 777/2020

1. Key takeaways

Egyptian device fees follow a dual-track structure: the fee item categories come from Prime Minister’s Decision No. 777/2020 (the executive regulation of Law No. 151/2019 establishing the EDA), while the service fees come from decisions issued by the EDA Chairman in this regard. Within the text of the EDREX guidelines, only two amounts are stated explicitly: the payment receipt for the case study file at 2,000 Egyptian pounds, and the technical support service fee of 2,000 Egyptian pounds for the certificate dedicated to export. The amounts for registration, re-registration, variations, import approvals and annual plans must be taken from the payment notices on the MeDevice platform and the current EDA Chairman decrees. (Practical estimate: amounts not stated in the official guideline texts are not listed here.)

Budgeting should therefore separate the stable statutory categories from the more frequently adjusted service fees, and should include the service fees that arise at restoration and amendment points, which companies commonly overlook when planning registration and import budgets.

2. Legal basis

3. Expert insights

Insight 1: fees are not set by the EDA at will — the regulation fixes the categories, the Chairman decree fixes the service fees.

The wording of item 1 of Section 4.1.1 of GL.CAMD.002 is that fees for medical device registration applications are charged according to the fee item categories set out in Prime Minister’s Decision No. 777/2020 (the executive regulation of the law establishing the EDA), and service fees are charged according to the decision issued by the EDA Chairman in this regard. Item 1 of Section 4.1.1 of GL.CAMD.007 repeats the same wording for import approvals. The structural consequence: fee item categories are relatively stable, while service fees adjust more frequently.

Insight 2: the two explicit amounts both appear on non-core services, and this is deliberate.

2,000 Egyptian pounds appears twice: first for the case study file — used for variations outside the established variation rules, requiring a payment receipt stating the device name (the device name is designated by the EDA registration officer); second for the certificate dedicated to export — local factories apply to the Central Administration and pay 2,000 Egyptian pounds for technical support services. Both are non-standard applications, so the guideline states the amount directly for ease of execution, whereas fees for standard registration and import float with the fee categories and service fee decisions and are therefore not fixed in the guideline.

Insight 3: payment is a precondition of acceptance, and the receipt must carry specific information.

At the registration stage, item 1 of Section 4.1.1 provides that the pharmacist of the evaluation and assessment department meets the applicant’s representative, adds the device name to the payment receipt and designates the competent department; at the variation stage, item 1 of Section 5.1 requires the payment receipt to state the relevant device name and the Device Variation Department of the Central Administration. The completeness of the payment receipt directly determines whether the procedural clock starts.

Insight 4: service fees appear at multiple separate points; they are not a one-off cost.

Service fees appear at: restoration after suspension of an import approval (one-time payment of the service fee within 90 days); restoration after suspension of an annual plan (the same); restoration after suspension of a special import (the same); annual plan applications (service fee charged according to the decision issued by the EDA Chairman in this regard); post-issuance amendment of an import approval (where the invoice value is not affected); and re-registration (service consideration charged according to the decisions issued by the EDA Chairman). Budgets should therefore include restoration and amendment as possible costs.

Insight 5: the case study channel has its own timeline and is the official exit for out-of-rule variations.

Section 8.1 of GL.CAMD.003: pay 2,000 L.E., submit through MeDevice, receive a reply within up to 3 working days from the application date, complete the documents required for evaluation within 5 working days — failing which the application is cancelled; upon acceptance the platform issues an initial acceptance number and evaluation begins, with a grace period of up to 45 working days from the acceptance date, during which importing the device (or, for local devices, the production raw materials) is allowed while the case study is completed. This is the only channel that expressly permits import during a grace period.

Insight 6: Section 8 of GL.CAMD.003 also defines three situations of major intended-use change.

Section 8 lists: (1) labelling changes reflecting a new indication; (2) major changes to the intended use, such as from single use only to reusable, or from prescription only to OTC; and (3) changes including an expansion of the target population. These three situations are major changes and cannot be processed as routine variations.

4. Practical recommendations

1. Verify fees under the dual-track structure: check fee categories in Decision 777/2020, and service fees in the current EDA Chairman decrees and the platform payment notices.
2. Include restoration and amendment service fees in budgets: both can arise during suspension recovery and post-issuance amendments.
3. Complete the payment receipt information: device name plus competent department (for variations, state the Device Variation Department of the Central Administration).
4. Route out-of-rule variations through the case study channel: budget the 2,000 L.E. and the 3, 5 and 45 working day milestones.
5. Budget the 2,000 L.E. technical support service fee for the export-only certificate.
6. Treat major intended-use changes (single use to reusable, prescription to OTC, population expansion) as major changes.
7. Do not cite amounts from unofficial sources: all amounts follow the platform notices and Chairman decrees.

5. Verification checklist

• □ The fee item categories have been confirmed against PM Decision 777/2020
• □ Service fees have been confirmed against the current EDA Chairman decrees and the MeDevice payment notices
• □ The payment receipt states the device name and the competent department
• □ The case study channel budget includes the 2,000 L.E. and the 3 / 5 / 45 working day milestones
• □ The 2,000 L.E. technical support service fee for the export-only certificate has been budgeted
• □ Service fees for restoration and post-issuance amendment are included in the budget
• □ The three situations of major intended-use change have been identified and will be handled as major changes

Regulatory information verified as of 29 October 2026. The legal basis of fees described here follows Prime Minister’s Decision No. 777/2020 and the provisions cited in the EDREX guidelines; the two explicit amounts (2,000 L.E.) follow the current text of Sections 8.1 and 9.1 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.