Customer discovery interviews, and how many are enough
B2B customer discovery interviews: the sample size the research converges on, why your segments change that number, and the questions that get honest answers.
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In Saudi Arabia the authorised representative slot for your device group is exclusive, and the regulator says the representative stays responsible after the agreement ends. That makes partner choice the first sales decision, not an operational one.
A sales plan for Gulf healthcare usually starts in the wrong place. It starts with the hospital: who the clinical champion is, how to reach the procurement committee, what the evaluation will look like. All of that matters eventually, and none of it is the first constraint.
The first constraint is that in Saudi Arabia you cannot put a device in front of a hospital at all until somebody holds a licence to represent you, that licence is exclusive for your device group, and the terms on which it ends are set by the regulator rather than by your contract. Which means the decision that determines your first two years in the market is one you make before you have met a single customer, and it is close to irreversible.
The Saudi Food and Drug Authority publishes its establishment rules openly, and they are worth reading directly rather than through a consultancy summary. The two documents that matter are the guidance on licensing procedures for medical device establishments and the underlying requirements document, MDS-REQ 9, version 2.0 dated 15 January 2025.
What they describe is not a single gate. It is a set of separate licences, and the one you need depends on what you are actually doing in the market rather than on what your contract calls it. A foreign manufacturer that appoints a representative, a company that imports, and a company that distributes are three positions with three licence types, and holding one does not grant the others. If your partner intends to import and distribute as well as represent you, that is more than one licence and more than one fee.
This is the part that changes how you should think about partner selection, and it is stated plainly in the requirements.
An authorised representative must, in the regulator's own words, ensure that no other authorised representative has been appointed for the same class or general group of the medical devices. It appears twice: once as a condition of being licensed, and again as a standing obligation to notify the manufacturer and confirm it.
Read that as a commercial fact rather than a compliance note. Representation for your device group is a single slot. You are not negotiating one of several parallel arrangements, you are allocating the only one, and the partner who holds it holds your access to the market. The usual instinct in a new market is to sign two or three partners and see which performs. Here that option does not exist in the form you are used to.
There is a second structural detail with the same flavour: a representative needs a separate licence for each manufacturer it represents in the Kingdom. A partner with a broad portfolio has a licence per principal, which tells you something useful. You can ask how many they hold, and the answer is a measure of how much attention yours will get.
Most partner agreements are written with a termination clause and a notice period, and both parties assume that settles it. For a Saudi authorised representative it does not.
The requirements state that the representative's responsibility for the devices covered by the agreement does not expire when the agreement is terminated or lapses, unless the manufacturer appoints a replacement representative, or the devices are no longer available in the market or with users. The obligation follows the product, not the paperwork.
The practical reading is that you cannot leave the slot empty. If you want to change partners, the new appointment has to be lined up before the old one ends, and the regulator has to be told. A partner who understands this has real leverage in any renegotiation, and a first agreement signed without it in view is a weaker position than it looks. The general version of this argument, that signature is the start of the work rather than the end of it, is in why signing changes nothing.
The reputation of Gulf healthcare entry is that it is slow and expensive. The published numbers say something more specific: the establishment licensing is fast and cheap, and the slow expensive parts are elsewhere.
| Licence | Period | Published fee |
|---|---|---|
| Authorised representative | One to ten years, by choice | SAR 2,600 per year |
| Importer or distributor, class A | Yearly | SAR 25,000 |
| Importer or distributor, class B | Yearly | SAR 15,000 |
| Importer or distributor, class C | Yearly | SAR 8,000 |
| Importer or distributor, class D | Yearly | SAR 5,000 |
| Device manufacturer | Five years | SAR 5,000 |
Two things to take from that table. The first is that the class is not something you choose: establishments are classified through an electronic questionnaire in the regulator's GHAD system, which takes in the type of establishment, the activities practised, the number of employees, the scope of coverage and the categories of devices. A five-fold fee difference sits on the output of a form, so it is worth seeing your partner's classification rather than being told it.
The second is the timing. For representatives, importers, distributors, warehouses and maintenance providers, the guidance says the application is studied, the fee is paid and the licence is issued immediately, within a maximum of two working days, with the inspection taking place later, after issuance. A manufacturer licence takes a different route: joint field inspection first, then the licence, within a maximum of seven working days.
So the administrative gate is days, not quarters. When an entry plan slips by a year, the licence was almost never the reason. The reasons are device marketing authorisation, central procurement cycles, and the time it takes to earn a first reference, and only the last of those is inside your control.
Where the rules do bite is on the quality side. Representatives, importers and distributors in the higher establishment categories have to produce an ISO 13485 certificate or an equivalent, or an inspection report from the regulator confirming compliance. If your intended partner has neither, the licence conversation has a prerequisite that is measured in months rather than days.
Alongside it sits post-market surveillance, and this is the obligation that most foreign manufacturers underestimate because it never appears in a sales plan. The representative has to cooperate with surveillance studies, report incidents that happened outside the Kingdom involving devices traded inside it, and notify the national centre for medical devices reporting of delays or unavailability that could pose high risk to medical services. That is an operational commitment on your side as much as theirs, because the information has to come from you. A partner is agreeing to be accountable for data they do not generate.
Three changes to the normal B2B sequence.
Public hospitals add a further layer, because a large share of Saudi public healthcare buying is consolidated through central procurement and framework agreements rather than conducted hospital by hospital. A clinical champion inside one hospital is necessary and not sufficient: the purchase may not be theirs to make. That is the same shape of problem as selling without a track record, treated at length in what works when you have no case studies yet.
Everything above is drawn from Saudi regulation, and it is the market where the rules are most clearly published. The UAE, Qatar and Kuwait each run their own registration and representation regimes, and the detail does not transfer. Treat the Saudi structure as the shape of the problem rather than the answer for the region, and read the specific market's own rules before committing to a partner there.
There is also a limit on what any of this tells you about demand. Licensing describes what you must do to be allowed to sell. It says nothing about whether anyone wants the device, and a completed registration is evidence of a completed registration rather than of a market.
The last one is about us. We advise on market entry, so the version of this that says the structure is complicated and worth getting help with is the self-serving version. The useful part is narrower and you can act on it without us: read the two documents, ask your intended partner which licences they hold and what their GHAD classification is, and get the replacement mechanism into the first agreement rather than the second. If a prospect or partner cannot answer those, that is information, and the cost of waiting to disqualify applies to partners too.
Send three things: the device group as the regulator would classify it, the partner you are considering with the licences they say they hold, and the draft agreement if there is one. We will come back with the questions to put to them, the replacement mechanism to add before signing, and an honest read on whether the exclusive slot is being allocated well.
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