Arabic Labelling and IFU Requirements for Medical Devices in Egypt

1. Key takeaways

Egypt maintains a dedicated labelling regulatory guideline (issued in 2022) that divides the minimum labelling data for devices circulated in Egypt into four categories: ① product information (trade name, product name, code / model / Ref., batch or serial number, special handling precautions, special storage precautions, single-use indication, expiry date, UDI); ② factory information (factory name, address, country of origin); ③ sterile products only (the word or symbol for sterilization plus the sterilization method); and ④ Egyptian importer or agent information (the company’s full name and the address recorded in the importer register). Among the general requirements, the two prohibitions violated most often are: over-labelling is prohibited and double-labelling with contradictory information is prohibited. A device that is otherwise fully compliant can be barred from import and trading solely because its label carries a second, inconsistent layer.

2. Legal basis

3. Expert insights

Insight 1: the official text reads Arabic or English, at least one — which differs from the industry claim that non-professional users must have Arabic.

The first sentence of Section 6 states that the data must be written in Arabic or English, at least one of the two, and must be legible and understandable for practitioners in the medical field and ordinary Egyptian citizens. That is the direct wording of the official text. (Practical estimate: some industry service providers state that professional-use devices may be English-only while household devices must include Arabic; that formulation does not appear in the guideline text, so confirm it in writing with the EDA labelling authority before finalizing artwork.)

Insight 2: language is not the only constraint — the readability audience is a constraint too.

Section 6 writes understandability for medical practitioners and ordinary Egyptian citizens into the same sentence. The practical implication: for a consumer-facing product, English-only may be deemed hard for ordinary citizens to understand during review or market surveillance. Audience analysis and language choice must be made together.

Insight 3: overprinting at customs is prohibited in principle, with only two exceptions.

The second clause of Section 6: devices must already carry all the data above at import, and none of that data may be processed (overprinted) at the customs site, with only two exceptions — country-of-origin information and Egyptian importer information — and even those only after all required documents are submitted and the competent authority consents. This directly rules out the import-first, label-at-port approach.

Insight 4: the carrier and durability of the data are explicitly specified.

The third clause of Section 6: data must appear at least on the sales unit, be clear and stable, and be difficult to remove, erase or blur over the validity period. This materially restricts thermal-transfer and other easily smudged printing methods.

Insight 5: the two prohibitions are market-level red lines, not merely registration-level ones.

The fifth clause of Section 6: import and trading are prohibited for any product carrying over-label (an upper label covering another label with different information) or double-label (two incompatible labels presented side by side); customs release is barred unless all legal and technical measures have been taken. Few regulatory texts elevate stacked labels to a prohibited-trading condition this directly.

Insight 6: large complete equipment sets have their own simplified rule.

The sixth clause of Section 6: when importing large equipment composed of multiple parts, the minimum data may be marked only on the major unit, provided there are descriptions, codes or serial numbers linking all parts to the base unit and enabling checking against the accompanying shipping documents and invoice. This is critical for imaging systems and laboratory automation lines.

Insight 7: the sterilization method must be marked; chemical sterilization may move to the IFU.

Section 4, item 3: sterile products must carry the word or symbol for sterilization together with the sterilization method. The annex adds that the sterilization method must be stated on the packaging of any device, except chemical sterilization , which may be stated on the packaging or the embedded IFU.

Insight 8: importer information must match the importer register.

Section 4, item 4 requires the full name of the importing company and the address as recorded in the importer register. After a change of agent or address, the label must be updated accordingly, otherwise a label change procedure is triggered.

Insight 9: UDI has entered the label fields on a when-applied basis, and the standalone guideline has already been revised for 2026.

Section 4, item 1 of the labelling guideline lists UDI (on the device label or packaging, when applied) among the minimum data. The standalone basis for UDI is EDREX: GL.CAMD.005, Version 02/2026, issued and applicable in May 2026, whose superior basis is EDA Chairman Decree No. 499 of 2021. But Chapter 4 on compliance dates states that the deadlines for UDI carriers on labels and direct marking of reusable devices will be announced separately once market readiness is complete. What companies should do in 2026 is data preparation, not an immediate overhaul of every label.

Insight 10: the guideline cites nine international standards and foreign regulations as reference sources.

Section 7 lists ISO 15223-1:2012 (symbols for medical devices), ISO 20417:2020 (information supplied by the manufacturer), ISO 13485:2016, the EU MDR, the Canadian labelling guideline, WHO TRS No. 902, 2002, Annex 9 (pharmaceutical packaging guideline), Malaysian MOH labelling requirements, Australian TGA labelling obligations, and FDA quality system regulation labelling requirements.

4. Practical recommendations

1. Check label fields against the four categories one by one: nine product items, three factory items, two sterile items, two importer items.
2. Set the language scheme by audience: consumer-facing products should be bilingual Arabic-English, confirmed with EDA in writing.
3. Never overprint at port: only origin and Egyptian importer data may be handled at customs after approval.
4. Validate print durability: labels must be hard to remove or erase across the validity period.
5. Eliminate over-label and double-label: institute a pre-shipment label uniqueness check.
6. Use the major-unit plus linking-code scheme for large equipment, reconciled against invoices and shipping documents.
7. Prepare UDI data now, wait for the announcement before relabelling: track EDA notices on UDI compliance deadlines.

5. Verification checklist

• □ Minimum data in all four categories checked item by item (product / factory / sterile / Egyptian importer)
• □ Language scheme determined (officially Arabic or English, at least one) and assessed by audience
• □ Expiry date format meets the minimum year-month requirement
• □ Sterile products marked with the sterile word/symbol plus sterilization method (chemical sterilization may move to the IFU)
• □ Egyptian importer name and address match the importer register
• □ Label carrier durability verified (hard to remove / erase over the validity period)
• □ No over-label or double-label condition
• □ UDI data prepared per GL.CAMD.005 (02/2026), compliance deadline pending announcement

Regulatory information verified as of October 29, 2026. Labelling requirements follow Sections 4–6 of the EDA Regulatory Guideline on Labelling Requirements for Medical Devices, Medical and Laboratory Equipment, IVDs, Components and Production Inputs (2022); UDI requirements follow EDREX: GL.CAMD.005 Version 02/2026 (issued and applicable in May 2026).

• Local resources in Egypt: GRZAN supports manufacturers from the Chinese mainland and overseas in dealing with the Egyptian Drug Authority (EDA) on medical device registration, import approval and change applications, including registration applicant scheme design (import company / local factory / scientific office), scientific committee evaluation preparation, reference-country free sale certificate route argumentation, Arabic labelling and IFU localization, and vigilance system and periodic reporting set-up.
• Service capabilities: product attribute and risk classification (device Class I–III / IVD Class A–D), registration and re-registration, system and bundled registration applicability, three-category change determination, import approval and the annual import plan, vigilance reports and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.