ISO 13485 and Legal versus Actual Manufacturer Rules in Egypt

1. Key takeaways

In its change guideline (EDREX: GL.CAMD.003 Version 3), Egypt provides two definitions that govern every OEM and ODM dossier. The legal manufacturer is the entity responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under its own name, regardless of whether those operations are performed by that entity itself, on its behalf, or by a third party; the legal manufacturer is responsible for product quality. The actual manufacturer is the entity that actually manufactures and performs packaging on behalf of the legal manufacturer. The corresponding certificate requirement is: ISO 13485:2016 issued by an internationally recognized certification body and covering the product category, or the combination of 510(k) plus EN ISO 13485:2016. These definitions decide whose name goes where in the dossier, whose quality system is audited on paper, and which certificates are acceptable — mislabelling the two roles is a recurring deficiency among manufacturers that outsource production.

2. Legal basis

3. Expert insights

Insight 1: the Egyptian legal manufacturer definition covers the ODM/OEM scenario, and responsibility cannot be transferred.

The phrase regardless of whether those operations are performed by that entity itself, on its behalf, or by a third party expressly brings contract manufacturing within the legal manufacturer’s scope of responsibility. Where a Chinese manufacturer sells under its own brand while a third-party factory produces, the brand owner is the legal manufacturer and the factory is the actual manufacturer, and both must appear in the Egyptian dossier with their names and complete addresses.

Insight 2: the certificate must cover the product category — possessing a certificate is not enough.

Annex 1, item 6(ii) states: ISO 13485:2016 issued by an internationally recognized certification body, provided that it covers the product category. A certification scope that is too narrow — for example, covering only one category of consumables while excluding the product being registered — is a high-frequency deficiency point. Check the scope statement of the certificate itself against the registration list before filing, not the other way around.

Insight 3: on the FDA route, ISO 13485 can be replaced by the cGMP wording in the CFG.

Annex 1 provides that where a USFDA CFG is obtained, a CE certificate is no longer required; and where the FDA certificate states that the factory appears at that time to meet current good manufacturing practice (cGMP) requirements, an ISO 13485 certificate is likewise not required. This is Egypt’s reciprocity arrangement for the US pathway, and it can remove an entire audit-document workstream for US-cleared products.

Insight 4: the 510(k) route requires EN ISO 13485:2016 alongside the 510(k).

The alternative combination in Annex 1 is the 510(k) (FDA Clearance) certificate issued by the US FDA, plus EN ISO 13485:2016 issued by an internationally recognized certification body and covering the product category. A 510(k) alone cannot substitute for the quality system certificate — the pair travels together.

Insight 5: the accreditation chain of the certification body must be traced up to the IAF level.

Section 9 of GL.CAMD.007 notes under the ISO 13485 verification item that the certification body must be accredited by an IAF-recognized accreditation body (the list of accreditation bodies is available at iaf.nu), and that the certificate must state the scope (covering the production/manufacture of medical devices), the certificate number, the issue date and the validity period. Certificates held by Chinese companies from domestic certification bodies must be traced back to confirm whether their accreditation body is an IAF member.

Insight 6: F-Toll (contract manufacturing) is a distinctly Egyptian local production form, with responsibilities written into the contract and reviewed by legal affairs.

Annex 3 requires a valid F-Toll manufacturing contract between the registration licence holder and the actual manufacturer, setting out both parties’ responsibilities in legal and technical matters, signed and stamped by both parties, legalized by the notary office of the Real Estate Registration Authority, and subject to review and approval by the EDA legal affairs department. Under the contract the licence holder must assume full responsibility for product quality, sterility and all manufacturing steps (with the actual manufacturer sharing technical quality responsibility); register the devices with EDA and notify any change; obtain import approvals for production materials in the name of the actual manufacturer for the licence holder’s benefit (input invoices must include raw material batch numbers); store goods in licensed warehouses; keep original permanent records covering devices, batch numbers and quantities, and places of manufacture and distribution; implement the quality system at the actual manufacturer; establish a device vigilance system; and report global recalls/FSN/FSCA as well as incidents monitored within Egypt.

Insight 7: the actual manufacturer’s production start-up is gated by time.

Annex 3 states that the actual factory may produce only after the registration licence is issued and must keep the registration report in its records; and that the registration licence holder has no right to produce the same device under F-Toll (as the actual manufacturer) for another registration licence holder. Together these two rules define the exclusivity of the F-Toll arrangement.

4. Practical recommendations

1. List both the legal manufacturer and the actual manufacturer in the dossier, with names and complete addresses in separate fields.
2. Verify the scope of the ISO 13485:2016 certificate: it must cover the product category being registered.
3. Trace the certification body’s IAF accreditation chain back to an IAF member accreditation body.
4. Assess certificate substitution on the FDA route: a CFG stating cGMP exempts ISO 13485; a 510(k) must be paired with EN ISO 13485:2016.
5. Fix responsibility for ODM/OEM scenarios: brand owner as legal manufacturer, factory as actual manufacturer.
6. Run F-Toll projects through legal review first: the contract must be notarized and approved by the EDA legal affairs department.
7. Schedule the actual manufacturer’s production only after licence issuance: align the production plan with the certificate milestone.

5. Verification checklist

• □ Legal manufacturer and actual manufacturer distinguished, with names and complete addresses filled in
• □ ISO 13485:2016 issued by an internationally accredited certification body and covering the product category
• □ The certification body’s IAF accreditation chain verified
• □ Certificate states scope (including production/manufacture), number, issue date and validity period
• □ FDA-route products assessed for CFG (cGMP) or the 510(k) + EN ISO 13485:2016 combination
• □ F-Toll contract notarized and submitted for review by the EDA legal affairs department
• □ Actual manufacturer’s production start scheduled after issuance of the registration licence

Regulatory information verified as of October 29, 2026. The legal and actual manufacturer definitions follow Section 2 of EDREX: GL.CAMD.003 Version 3; certificate requirements follow Annex 1 and Annex 3 of EDREX: GL.CAMD.002 Version 2 and Section 9 of GL.CAMD.007 Version 2.

• 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.