Build the quote yourself
Devices or medicines. Choose the market, the class or pathway, and the shape of your project. Every line below is either a fee the regulator has published, or our own fixed fee. Nothing here is generated by an algorithm guessing at your budget.
Your project
The sheet updates as you go. Devices and medicines are priced by different authorities on different schedules, so start with the product.
Four markets are greyed out because we have not yet traced their fee schedules to a dated official publication. We would rather show you nothing than show you a number we cannot stand behind. Both can be selected together.
A to D, not I/IIa/IIb/III — Saudi Arabia runs its own classification rules and the manufacturer is responsible for the answer. The Emirati device fee does not vary by class, so this moves the Saudi line only. Where two rules conflict, the higher class wins.
Each family needs its own marketing authorisation, so the regulator's fee multiplies exactly. Our fee for families after the first is shown separately and is indicative — those are always quoted individually.
The import permit is charged as a percentage of consignment value, so it is the one fee that depends on how much you ship. Leave at zero to exclude it.
Defaults are indicative and will be stale by the time you read this. Official fees are invoiced to you at the amount actually paid, on the day it is paid — the sterling column is for planning, not for your budget approval.
Three of the six are greyed out, and for three different reasons. Saudi Arabia publishes its review periods for medicines but no fee schedule we could trace to a dated document. Egypt publishes no medicine fee schedule at all — amounts appear only inside guideline prose. South Africa gazettes its fee regulation as a scanned image with no readable text layer, so we hold the citation and not the numbers. Any of the three can be selected together.
Each regulator cuts this differently. EDE charges one fee for conventional and biological medicines and a lower one for the general sales list; the Turkish tariff knows only reference and generic, with no separate over-the-counter category; NAFDAC prices prescription medicines above over-the-counter ones and charges more again where Nigeria could make the molecule itself.
Each product needs its own authorisation, so the regulator's fee multiplies exactly. Strengths and pack sizes of the same product usually do not — that is a variation, and it is cheaper.
For a medicine this is usually the largest single line, and it is the one most quotes omit. The three answers produce three completely different numbers — and in Türkiye two of them produce the same one, which the sheet will explain.
Defaults are indicative and will be stale by the time you read this — the lira especially. Official fees are invoiced at the amount actually paid on the day it is paid. Note that Turkish fees are paid at the market rate; the euro used to set your Turkish price is a different, statutory rate, and that is on the market page rather than in this sheet.
Estimate
Saudi Arabia · Class B · 1 family
Estimated lines 0
What this will not tell you
Every competitor's calculator answers the question you actually asked — how long and how much, end to end. We have deliberately not answered it, because the honest answer is that four of the five things that decide it are unpublished and specific to you.
- Your calendar
Thirty-five and forty-five working days are review clocks. They start when a complete file is accepted and they stop when a deficiency letter is issued. The months before submission — and the queue at the legalising embassy — are the real timeline, and no regulator publishes them.
- Your classification, or your pathway
The class you tick above changes the fee. Whether it is the right class changes the project. For a medicine the equivalent is which reliance pathway admits you — and the clause that admits you is rarely the one you expect. Both are decided in writing, and both are the first thing the assessment does.
- Your file
A current CE or FDA dossier that needs reformatting and a dossier assembled years ago by a consultant who has since disappeared produce the same number here, and completely different projects.
- Your structure
Saudi Arabia wants one exclusive representative. The UAE requires at least two importers. If you are entering both, the structure is a design problem before it is a cost, and the wrong design is discovered at renewal.
- The markets that are greyed out
For devices, four of the six. For medicines, three — and for three different reasons, each stated on the selector. When we can cite a dated fee schedule, a market appears here. Not one day earlier.
- What the market will pay you
Medicines only, and it is the number that decides the business case. A Turkish price runs on a euro fixed by decree at 65 per cent of last year's average rate; a South African price is set once and moved only by the Minister's annual percentage; an Emirati price is set against a reference list that is published nowhere. This sheet prices the registration. It does not price the outcome, and no calculator honestly can.
So what is this for?
To stop you being quoted a round inclusive number. If a proposal says "£28,000 all in" and cannot break out what SFDA charges from what the consultant charges, this page shows you the half that is a matter of public record — and lets you ask about the other half.
Where the figures come from
- SFDA schedule of medical device marketing authorisation fees, May 2025 edition — unchanged from the December 2024 edition. Classes A to D, SAR 15,000 / 19,000 / 21,000 / 23,000; renewal SAR 5,000; label, IFU or advertising update SAR 1,100.
- SFDA requirements for licensing medical device establishments, January 2025 revision — Authorised Representative licence SAR 2,600 per year, term one to ten years, with the exclusivity confirmation and continuing duties.
- SFDA marketing authorisation requirements, version 6 — the maximum thirty-five working day review where all requirements are met, all classes.
- Emirates Drug Establishment service pages for issuance and renewal of a medical device marketing authorisation, manufacturer registration, medical warehouse licensing, product classification and import permits — checked August 2026. EDE does not date-stamp these pages, so we re-confirm the schedule with the authority before it enters a written quote.
- Federal Decree-Law 38 of 2024, in force January 2025 — the requirement that the applicant be a UAE-licensed establishment, and Article 22(1), activated February 2026, requiring at least two importers for the same product.
For medicines
- Emirates Drug Establishment service catalogue for medicines, checked August 2026 — marketing authorisation AED 7,000 conventional or biological and AED 5,000 general sales list, renewal AED 3,500 and 2,500, variation AED 1,000, laboratory analysis AED 3,000, pharmacovigilance plan evaluation AED 1,000, pricing certificate AED 500, site registration AED 10,000, GMP certificate AED 2,000 per line per year, and the forty-five working day review.
- NAFDAC tariff, effective 31 January 2020 — still the only tariff published on NAFDAC's own tariff page. Prescription medicine US$1,280 where Nigeria could manufacture the molecule and US$1,200 where it could not, over-the-counter US$967, renewal at 80 per cent, foreign GMP inspection US$10,989.01 per site as a single flat figure, risk-based desk review US$5,000 where the site has already been inspected.
- NAFDAC regulatory directive on revised registration timelines, effective 1 May 2025 — the change from 120 to 240 working days. Reliance guideline DRR-GDL-035-01 §8.3 and regulatory directive NAFDAC-RDRR-005-04, effective 11 October 2025 — the sixty working day reliance route and the three-year validity of an inspection report relied upon.
- TİTCK price tariff, 23 March 2026 — application ₺816,512 for a new molecule or reference product and ₺489,908 for a generic, renewal ₺24,360, and foreign GMP inspection at ₺41,153 application plus ₺1,542,896 site inspection plus ₺100,663 per product plus ₺100,663 certificate. A 40 per cent reduction applies where the product is manufactured in Türkiye, which this sheet does not apply.
- Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği, Resmî Gazete 11 December 2021 no. 31686 as amended — article 14(1) the 210 days, article 12(1) the four annual scheduling rounds. İDD-KLVZ-21 revision 10, 22 September 2025 — the abolition of the desktop assessment route on 6 October 2023 and what PIC/S membership does and does not buy.
Our own fees are set by us and published on the pricing page in full, including what we decline to do. Third-party costs — translation, notarisation, embassy legalisation, sample shipping and testing — are estimates from projects of this shape and are passed through at cost with the receipt.
Two weeks turns this into a fixed number
The route assessment fills in every line above for your product, its class or pathway, and your markets — and tells you whether the sequence you have in mind is the right one. £1,450, credited in full if you proceed.
Check your route →Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp