Criteria for a Single Registration Number in Egypt

1. Key takeaways

Egypt allows multiple devices to share a single registration number where seven elements are fully identical: the trade name, the GMDN or UMDN code, the classification, the intended use, the manufacturer, the raw materials and the age group, with size differences excepted. Sutures, even where their raw materials differ, are not split and are still granted a single registration license. Where the seven elements differ, the devices are registered as independent devices; where the seven elements are the same but other differences exist, the file must be submitted to a dedicated scientific committee to determine whether the differences are substantive.

2. Legal basis

3. Expert insights

Insight one: the phrase excepting size differences is the most commercially valuable clause among the seven elements.

Within the seven elements, the age group element expressly excludes size differences, which means that different specifications of the same product line (lengths, diameters, capacities) can be consolidated under one registration number. For consumables manufacturers, this single clause directly determines the number of registration numbers and the associated fee scale. A portfolio of twenty sizes can, if properly presented as size variants of one age group, remain one registration unit rather than twenty, provided the dossier explains the variant logic clearly.

Insight two: sutures are the only express exception, since differing raw materials do not trigger a split.

Immediately after listing the seven elements, the guide adds that sutures are not to be split even where their raw materials differ, and are granted a single registration license. The direction of this exception is consistent with the wording of Sections 4.2.3 and 4.2.4, which state that sharing of raw materials is not required, and it shows that Egypt has adopted a pragmatic consolidation approach for consumables. Manufacturers of suture lines in multiple materials should therefore plan their filings around single registration numbers rather than assume a material-by-material fragmentation.

Insight three: identical seven elements with other differences go to committee determination, not automatic consolidation.

Section 11.2 provides that devices sharing the listed elements but differing in other respects must be submitted to a dedicated scientific committee to study those differences and determine whether they are substantive, and consequently whether the devices are to be split and registered separately. This creates a two-tier test: the seven elements are the hard gate, and the committee is the flexible gate. Companies should document the rationale for their groupings in advance, because the committee will look for reasoned evidence rather than commercial convenience when weighing materiality.

Insight four: orthopedic devices have their own specific rules, with four cumulative conditions and per-device committee submissions.

Section 11.3 provides that orthopedic devices registered as systems must satisfy the following: the rules apply to joints, screws and bone plates; the original catalog must be attached to the dossier to verify that the devices to be registered indeed belong to the same system; each device must be submitted individually to the dedicated scientific committee for orthopedic diseases and surgery; and the determination of the system must rest on a CE design examination certificate, an FSC or an FDA certificate, with the FSC or FDA certificate expressly listing the components of each system and their codes. For orthopedic manufacturers the practical meaning is that even under system registration, the number of committee submissions is not reduced by the consolidation.

Insight five: the original registration license is unique, and copies held by agents or distributors are not recognized.

Section 11.4 states clearly that the original of the registration license belongs to its owner and that copies held by any other agent or distributor will not be considered; the data of the registration license must not be deleted or altered in any way, failing which the license is invalid. This is a core rule of the Egyptian licensing system and the institutional basis for the practical exclusivity of the registration license holder role in Egypt. (Practical estimate: the term Egyptian Registration Holder, ERH, commonly used in the industry is a practitioner label rather than guide terminology; this article follows the guide’s wording of registration license owner and registration applicant.)

Insight six: devices administered through the oral, nasal or auditory routes must undergo separate testing within the registration procedure.

Section 11.6 provides that devices administered through the oral cavity, the nasal cavity or the auditory canal undergo analytical testing within their registration procedure. This is a product-attribute requirement independent of classification, and it is easily missed when the filing team organizes its work around class boundaries alone. Scheduling the analytical testing early avoids a late-stage stall in the registration procedure.

4. Practical recommendations

1. Partition the filing units against the seven elements: compare the trade name, GMDN or UMDN, classification, intended use, manufacturer, raw materials and age group item by item.
2. Consolidate size variants with confidence: the age group element expressly excludes size differences, but the dossier must state the variant logic.
3. File sutures under a single registration number: even with differing raw materials, the guide expressly does not split them.
4. Prepare the four orthopedic conditions under the system-specific rules: catalog verification, per-device committee submissions, and certificates listing component codes (CE design examination certificate or FSC / FDA certificate).
5. Avoid altering registration license data after submission: any deletion or change invalidates the license, and the change procedure must be used instead.
6. Reserve time for analytical testing of oral, nasal and auditory route products: such testing is required within the registration procedure.

5. Verification checklist

• □ The seven elements have been compared item by item (trade name / GMDN or UMDN / classification / intended use / manufacturer / raw materials / age group)
• □ Size differences have been handled under the exception clause and explained in the dossier
• □ Sutures have been treated under the rule that differing raw materials do not trigger a split
• □ Where the seven elements are identical but other differences exist, committee determination materials have been prepared
• □ Orthopedic products are covered by the original catalog, per-device committee arrangements and certificates listing component codes
• □ The ownership of the original registration license and the agency relationships have been clarified
• □ Time has been reserved for analytical testing of oral, nasal and auditory route products

Legal information verified as of 29 October 2026. The single registration number rules and the orthopedic system-specific rules described in this article follow the current text of Section 11 of EDREX: GL.CAMD.002 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.