Assembled from published figures, not from a model

Build the quote yourself

Choose the market, the class 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.

Regulator fees are quoted exactlyTaken from the authority's own published schedule, with the edition and the date we checked it.
Our fees are our own to stateFixed bands by market and class. We are quoting ourselves, so no source is needed — only a commitment.
Estimates are labelled as estimatesTranslation, legalisation and shipping are marked est and kept out of the published total.

Your project

Six inputs. The sheet updates as you go.

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.

Conversion rates you control

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.

Estimate

Saudi Arabia · Class B · 1 family

Published figures 0
Estimated lines 0
The part a calculator cannot do

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 We have deliberately not answered it, because the honest answer is that four of the five things that decide it are unpublished and specific to you.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

    The class you tick above changes the fee. Whether it is the right class changes the project. That is decided against SFDA's classification rules and defended in writing, and it is 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 four other markets

    Egypt, Türkiye, Nigeria and South Africa are greyed out above. When we can cite a dated fee schedule for each, they will appear here — and not one day earlier.

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

  1. 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.
  2. 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.
  3. SFDA marketing authorisation requirements, version 6 — the maximum thirty-five working day review where all requirements are met, all classes.
  4. 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.
  5. 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.

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 device, your class 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