Active Devices, Software and SaMD Requirements in Egypt

1. Key takeaways

Egypt’s officially verifiable basis for active devices and software devices rests on two pillars. The first is definitional: the device definition in Law No. 151/2019 and the EDA guidelines expressly covers instruments, apparatus, appliances, software, implants, reagents, materials or other articles that do not achieve their principal intended action by pharmacological, immunological or metabolic means. The second is identification: the UDI guideline EDREX: GL.CAMD.005 Version 02/2026 (issued and applicable in May 2026) applies to all devices, accessories and IVDs supplied to the Egyptian market (excluding investigational, test and custom-made devices), with its superior basis in EDA Chairman Decree No. 499 of 2021, and its glossary expressly lists SaMD (software as a medical device). (Practical estimate: the specific standards list for electrical safety and EMC, and the specific software life-cycle documentation requirements, follow the technical requirements or review comments currently published by EDA; this article makes no presumption.)

2. Legal basis

3. Expert insights

Insight 1: software in Egypt is covered by the definition itself, leaving no room for an is-it-a-device dispute.

The device definitions in the EDA labelling guideline and the UDI guideline both list software, alongside instruments, apparatus, appliances, implants, reagents and materials. SaMD in Egypt therefore follows the device registration path, not a general software or IT product path — a point worth fixing early in project planning because it changes the entire evidence package.

Insight 2: UDI applies to devices, accessories and IVDs, and the scope statement is very broad.

Chapter 1, Scope, item A of GL.CAMD.005: it applies to all devices, their accessories and IVDs to be supplied to the Egyptian market, excluding investigational, test (investigational) and custom-made devices. Scope item B extends the obligated parties to manufacturers, agents, importers, distributors and healthcare providers — UDI is not only the manufacturer’s business.

Insight 3: the mandatory UDI labelling date is not yet published, but the data obligations at import already exist.

Chapter 4 on compliance dates states that the deadlines for placing UDI carriers on device labels and for direct marking of reusable devices will be announced separately once market readiness is complete. But Chapter 3 on import and distribution control already requires: for each device identifier (DI) of a device imported into the Egyptian market, the manufacturer or agent or importer must provide the corresponding production identifier (UDI-PI), the destination (such as a specific distributor or hospital), and the quantity of the batch-controlled device. In short, the data reporting obligation comes first, mandatory label carriers come later.

Insight 4: own-brand and repackaging entities are treated as manufacturers in the UDI sense.

Chapter 1, item 8: own-branders/private labellers who label third-party devices under their own name and/or trademark are deemed the manufacturer of the device and are responsible for the UDI of the labelled device. Item 9: re-labellers, re-packagers and re-manufacturers must create a new UDI for the device concerned and replace the original OEM’s UDI (where present); the new UDI must meet all guideline requirements, and records of the original device’s UDI must be kept (where obtainable); a device returned to its original user after repair is not subject to UDI on that account, but a device that is not necessarily returned to its original user after repair is subject to UDI. These clauses bear directly on Chinese manufacturers doing OEM labelling and local repackaging.

Insight 5: the barcode technology choice has explicit rules.

Chapter 1, items 9–11: where UDI information can be carried by a two-dimensional barcode, a two-dimensional barcode is recommended; where RFID technology is used, a linear or two-dimensional barcode or another type of barcode must still be provided on the label; and barcodes must be verified against the applicable ISO/IEC standards. Item 2 adds that where a device has already been coded by another designated issuing agency, the corresponding rules apply.

Insight 6: the technical evidence for active devices falls under the general technical file items, with no dedicated standards list.

The technical file items of GL.CAMD.002 Annex 1 (sketch diagram, catalog, analysis certificate) apply equally to active devices, but the guideline does not list a designated standards set for electrical safety or EMC. (Practical estimate: whether specific standards such as the IEC 60601 series must be submitted follows the current EDA technical requirements or deficiency comments; companies should prepare to the highest readiness level and confirm with EDA in writing before submission.)

Insight 7: labelling of large complete equipment sets can be simplified, but the UDI and serial numbers must reconcile.

Section 6 of the labelling guideline permits large multi-part equipment to carry the minimum data on the major unit only, provided descriptions, codes or serial numbers link the parts and allow checking against documents and invoices; this dovetails naturally with the DI/PI structure of GL.CAMD.005.

4. Practical recommendations

1. Plan SaMD registration on the device path: never through the IT product path.
2. Build UDI data first, wait for the announcement before relabelling: track EDA notices on UDI compliance deadlines.
3. Satisfy the Chapter 3 data obligations at import first: for every DI, have UDI-PI, destination and batch quantity.
4. OEM labellers bear UDI responsibility as manufacturers; re-packagers and re-labellers must create new UDIs and keep records of the original ones.
5. Prefer two-dimensional barcodes; with RFID, provide a barcode alongside and verify against ISO/IEC standards.
6. Use the major-unit plus serial-number linking scheme for equipment sets, consistent with invoices and shipping documents.
7. Prepare electrical safety and software life-cycle documentation to the highest readiness level, confirming the current standards list with EDA in writing.

5. Verification checklist

• □ Product attributes determined (software / active devices included) and planned on the device path
• □ Applicability of GL.CAMD.005 (02/2026) confirmed (not investigational / test / custom-made)
• □ For each imported DI, UDI-PI, destination and batch quantity data prepared
• □ OEM labelling / repackaging entities bear UDI responsibility as manufacturers
• □ Barcode scheme fixed (two-dimensional preferred; RFID requires a coexisting barcode and ISO/IEC verification)
• □ Major-unit labelling and part serial-number linking established for equipment sets
• □ Electrical safety and software life-cycle document list confirmed with EDA in writing

Regulatory information verified as of October 29, 2026. The device definition follows Article 1 of Law No. 151/2019 and the definition clauses of the EDA guidelines; UDI requirements follow EDREX: GL.CAMD.005 Version 02/2026 (issued and applicable in May 2026) and EDA Chairman Decree No. 499 of 2021.

• 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.