Of the six markets on this site, Egypt is the only one that has written the UK mark into its own procedure. EDA lists the United Kingdom among its reference countries and publishes a dedicated route for devices marketed in Great Britain — which makes it, for a UKCA-only manufacturer, the most accessible market here rather than the hardest.
Do you also make medicines? Egypt is the only market on this site that names the UK for both. For medicines the United Kingdom sits on EDA's twenty-four country reference list, and a site there is waived from EDA's on-site inspection. The medicines page for Egypt →
EDA's registration guideline defines the applicant as an importing company, a local facility or a scientific office. All three are Egyptian-established. A foreign manufacturer cannot file on its own behalf, and the choice between the three decides more about your position in the market than any other decision on this page.
An importing company files on the strength of a legalised delegation letter from you and a legalised distribution or agency contract. That is the quickest route and the one a distributor will propose, because it puts the registration on the side of the table that also sells your product.
A scientific office is the alternative most UK manufacturers have never heard of. It holds a licence to represent a manufacturer scientifically, and it can be your own establishment rather than your distributor's. Where it registers devices that are not from its parent company, EDA requires a legalised delegation letter from the legal manufacturer and a no-objection letter from the parent company.
Why we raise it first. Egypt does publish a transfer procedure, so the registration is not permanently trapped with whoever files it — see the structure section below. But every route through that procedure needs your outgoing partner's cooperation. Choosing the holder at the start costs a conversation; changing it later costs a negotiation.
Egypt runs the European scheme — Class I sterile and non-sterile, IIa, IIb and III. EDA does not operate its own classification rulebook: the class is taken from the certificates you submit, under the EU, US or Canadian rules that produced them, and reviewed by the Examination and Evaluation Department. Class IIa, IIb and III devices from outside the reference countries go to a Scientific Committee.
You, with usImporting company, local facility or scientific office. This is a commercial decision with regulatory consequences, and it is the one worth spending two weeks on before anything is filed.
Us, with youWhat EDA wants depends on which mark you carry, and the three routes are genuinely different — see the switcher below. If you hold UKCA, the main registration guideline and the Great Britain guideline have to be read together, because the first does not mention UKCA at all.
You, assembled by usEgypt is not a party to the Hague Apostille Convention, so an apostille does not work here — documents are authenticated by the Chamber of Commerce and the Egyptian Embassy in the country of origin, and mandates additionally need bank signature verification. There is one important relief, and it is in the next section.
You, tracked by usEDA's electronic platform. Since November 2025 there are published minimum-requirement notices for submitting through it, covering devices, medical equipment and in-vitro diagnostics separately.
Applicant, managed by usRegistration and import are two separate acts by two separate administrations. An annual import approval is granted per foreign factory without specifying quantities, and then every individual invoice needs its own customs release approval through MeDevice. The import approval is issued to its holder and may not be waived or transferred.
Shared — we run the calendarThese are not three ways of saying the same thing. The route you take changes which documents EDA requires, and in one case removes a requirement other applicants have to satisfy.
The legalisation relief, which is worth more than it looks. EDA's registration guideline states that quality certificates issued by the reference countries — an FDA CFG, a CE certificate, an ISO 13485:2016 or EN ISO 13485:2016 certificate, a free sale certificate — do not need Chamber of Commerce and Egyptian Embassy legalisation where the administration has verified their authenticity directly with the issuing body. Where that verification fails, legalisation comes back. Since the United Kingdom is on the reference list, a UK manufacturer is inside this relief — and since Egypt has no apostille route, it is the only saving available.
EDA's reference-country list runs from Australia to the United States and includes the United Kingdom. Beyond that, EDA publishes a dedicated instrument for devices marketed in Great Britain and not required to be marketed in the European Union, which records that on 11 May 2022 the Central Administration of Medical Devices decided to continue recognising the United Kingdom as a reference country after Brexit. It requires ISO 13485:2016 plus UKCA certificates according to the classification, in addition to the standard registration file. No extra condition, no penalty, no second assessment.
For a manufacturer that moved from CE to UKCA and has been told in market after market that the mark buys nothing, this is the exception — and it is worth knowing before the sequencing conversation, not after.
Three qualifications, all of which we would rather state than let you discover:
On the Certificate of Free Sale. EDA wants one from the Ministry of Health of the country of origin where that is a reference country. For the UK that is the MHRA, which issues free sale certificates to a UK manufacturer or UK Responsible Person as electronically signed PDFs, conditional on DORS registration. MHRA notes that the FCDO will not authenticate those PDFs directly and that a notary must verify them with MHRA first — a step to start before you need it.
We published, earlier on this site, that the Egyptian authorisation was reported to be non-transferable. Having now read the regulator, that is wrong and we have corrected it. EDA publishes a procedure for changing the registration applicant, at version 3, effective 1 September 2025, and it runs as a variation in the "tell and do" tier — notify before implementing, no consignments until approved.
The documents EDA lists for a transfer to a new importing company include the original valid registration, a waiver from the outgoing applicant approved by that company's chairman and attested by a bank or EDA's legal administration, the new applicant's commitment to the device vigilance system, its importer record licence, and a letter from the legal manufacturer terminating the agreement with the former applicant, authenticated by the Chamber of Commerce and the embassy. There are parallel routes for moving a registration from an agent to a scientific office, and to an affiliate scientific office.
Two limits are worth carrying into any negotiation. Where the required documents cannot be submitted, EDA's own text provides that the new applicant applies for a fresh registration and is given a one-year grace period to import from the date the file is accepted, with a further six months available to complete the procedure. And where you change both the legal manufacturer and the actual manufacturer, EDA treats the product as a new device and the variation route is closed entirely.
How we structure it. The same principle as in Saudi Arabia, reached by a different mechanism: the entity that holds the registration should not be the entity that profits from selling. In Egypt the scientific office makes that separation possible without you establishing a trading company. It is more work at the start and it is the difference between changing distributor and re-registering.
EDA publishes review periods per step, in working days, and they are short. They do not sum to an end-to-end date, because applicant response windows and suspension periods sit between them — a file can be suspended for up to 90 working days while documents are completed, and 60 working days is the standard window for the applicant to satisfy requirements.
| Step | Normal | Fast track |
|---|---|---|
| Response on acceptance of the file | 5 working days | 3 working days |
| Evaluation of the registration file | 20 working days | 7 working days |
| Applicant window to satisfy requirements | 60 working days | — |
| Suspension where documents are incomplete | up to 90 working days | — |
| Variation — first response | 8 working days | 5 working days |
| Variation — evaluation | 25 working days | 10 working days |
| Customs release, per invoice | same working day if filed before 14:00 | — |
From EDA's registration guideline GL.CAMD.002 v02 (09/2025), the variations guideline GL.CAMD.003 v03 (01/09/2025) and the import approvals guidelines GL.CAMD.007 and .008, both v02 (09/2025). Import approvals run on an annual cycle from 1 July to 30 June, and an import approval is valid for one year from issuance.
EDA lists more than a hundred chargeable medical device services, from registration and re-review to factory inspection and per-consignment release banded by invoice value. The list carries no amounts. Every device guideline defers the figure to a table annexed to the executive regulations of the establishing law, and that table is not reproduced on EDA's site. The only two device amounts we could confirm are EGP 2,000 for a case-study file and EGP 2,000 for export certificate technical support.
EDA does publish amounts for other sectors, so this is a publication gap rather than a drafting convention. Fee figures for Egypt circulate widely in US dollars on consultancy sites, cited to nothing. We are not repeating them. For a live project we obtain the figure from EDA and invoice it at cost with the receipt, exactly as we do everywhere else.
Published here rather than left out, because the things a page omits are where a buyer gets hurt. Each of these is a question we will put to EDA during an assessment.
No published schedule for device registration, renewal, variation, importer licensing, free-sale issuance, classification determination or per-consignment release. Confirmed absent, not merely unfound.
Five years is confirmed for in-vitro diagnostics and for locally manufactured devices. The guideline covering imported devices with international quality certificates is Arabic-only and we have not yet read it end to end, so we will not state a term for that category. Secondary sources say ten years; nothing primary supports it.
Widely asserted, and plausible. We did not find it stated in any EDA device guideline we read. We are not asserting it either way, and we would budget for translation regardless.
The transfer documents require the new applicant to commit to the device vigilance system, so one exists. We could not find a device-specific post-market surveillance or adverse-event guideline on EDA's medical device page. The 2026 good pharmacovigilance practice decree appears to concern medicines.
Present on the registration side, apparently absent on the import side. Being re-read before we assert either.
Start the free sale certificate first. It is the longest pole. MHRA issues it electronically, the FCDO will not authenticate an MHRA PDF directly, and a notary has to verify it with MHRA before anyone abroad will accept it. Everything else in the file can be assembled while that runs.
EDA also issued a notice in August 2026 on registering devices with differences in composition data. The UKCA instrument, GL.CAMD.010, remains at version 2 of July 2023 and was not part of the September 2025 refresh.
If you carry UKCA and have been told it is worth nothing abroad, Egypt is the counter-example. Send us the device and we will tell you what the file needs, what the structure should be, and where Egypt sits in your order.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
Two cautions on this page in particular. EDA publishes its device guidelines as PDFs and several are Arabic-only, so where we relied on an English text we say which document it was; where the document we needed is Arabic and unread, we have said so in the gaps section rather than filling it. And EDA numbers and versions its guidelines properly, which most regulators do not — so if a provider quotes you an Egyptian requirement without a GL code and a version, ask which document they mean. Re-checked quarterly and after any EDA decree or notice affecting devices.