Medical Distribution Licences: Step by Step
The documents needed for medical distribution are these: the standard workplace documents, a sales centre authorisation certificate, registration in the Product Tracking System (ÜTS), the appointment of a responsible manager, and an authorisation contract with the brand whose distribution you take on.
Two items set the pace in this branch: the responsible manager and the brand contract. The other steps move in predictable times. Below I set them out in order, each with its duration and its common mistake.
Step 1: Settle the brand and the product portfolio
Whose brand, and which product group, will you distribute? That question decides everything else, because the group changes storage conditions, the responsible manager’s profile and the capital required.
Common mistake: starting with a wide portfolio. Taking on products with different storage conditions at the same time makes the warehouse set-up heavier than it needs to be.
Duration: talks take weeks. Needed: a business plan and a presentation of your sales capacity.
Step 2: Resolve the responsible manager question
Within the sales centre framework a responsible manager is expected, and that person must meet the education conditions. In distribution they also become the centre of regulatory monitoring.
Common mistake: leaving this item until after the brand contract. The brand usually assesses your structure too; a candidate with the responsible manager in place stands stronger.
Duration: days if the person is ready, weeks if you must look.
Step 3: Incorporation and tax registration
In distribution a company structure is all but compulsory; brands and corporate customers will not work with a sole trader. Notary, trade registry and tax registration are completed at this step.
Duration: one to two weeks. Needed: articles of association, capital, registry formalities.
Step 4: Warehouse and premises set-up
The storage arrangement is built around your product group. For products needing cold storage, a temperature-controlled area and a monitoring device; for sterile products, shelving that protects packaging integrity.
Common mistake: thinking of the warehouse in square metres alone. Partitioning and storage conditions decide more than floor area does.
Duration: two to four weeks to set up. Needed: racking, temperature monitoring, partitioning.
Step 5: Sales centre authorisation certificate
The application goes to the provincial health directorate; premises, responsible manager and staff conditions are assessed and an on-site inspection is carried out.
Duration: weeks. Needed: premises plan, responsible manager paperwork, staff certificates.
Step 6: Product Tracking System registration
You register in the system as a distributor and report your inward and outward movements. As the middle link in the chain, your record-keeping affects both the manufacturer and the point of sale.
Common mistake: treating the system as separate from your accounting software. When the two records do not agree, stock discrepancies break traceability.
Duration: registration takes days, integration longer. Needed: an electronic signature and authorisation.
Step 7: The brand authorisation contract
Four headings must be settled in the contract: territorial exclusivity, the minimum purchase commitment, the price and discount structure, and how costs are shared in the event of a product recall.
Common mistake: signing a minimum purchase commitment without knowing your sales capacity. If you cannot sell the volume you commit to, the stock stays with you.
Duration: negotiation takes weeks. Needed: legal review.
Step 8: Municipal licence and opening
The workplace opening and operating licence is obtained and the social security declaration filed. The licence class is assessed according to the nature of the warehouse.
Duration: one to three weeks.
Building a dealer network
As a distributor you sell to points of sale, and those points must hold authorisation certificates of their own. Selling a medical device to an unauthorised point means the chain breaks at your link.
What to hold in the dealer file
- A copy of the dealer’s sales centre authorisation certificate
- Tax and trade registry details
- Which product groups it works in
- Dispatch and batch records
The first item is asked at inspection. With the dealer file in order, the chain holds.
Where does liability sit in a dealer network?
Taking dealers on beneath you grows the volume but does not spread the liability. Keeping the product moving in line with the records, and traceable, is your chain’s job.
What must be in writing with a dealer
- Which product groups it is authorised in
- Its obligation to report sales and stock
- Its undertaking to meet storage conditions
- The route to follow in the event of a recall
- The conditions on which the authority ends
The fourth item is the most critical. When a recall starts, how quickly you can collect the stock a dealer holds shows how sound your chain is.
The test in choosing a dealer
Handing a medical device to a point without an authorisation certificate breaks the chain. Do not send product before you have seen a candidate’s own authority and record-keeping; a gap at that point comes back to you.
Checklist
Before you start: the brand and portfolio decision, the responsible manager, the capital plan.
At incorporation: company formation, tax registration, trade chamber, warehouse set-up.
Before trading: sales centre authorisation certificate, system registration, brand contract, municipal licence.
While trading: dealer files, batch records, stocktaking and reconciliation.
For the general order see the business licence roadmap, for the retail side our medical supply shop article, and for capital bands our medical sector page.
Warehouse and logistics investment is the backbone
A distributor’s commercial strength comes from the warehouse. The faster and the more accurately you can dispatch, the firmer your place in the chain.
The order a warehouse needs
- Product groups separated and labelled
- A suitable area and a record for products needing storage conditions
- A quarantine area: a separate section for returns, damaged or pending stock
- Shelf life tracking and first in, first out applied
- Layout by batch and serial number
The third item is the one most often missing. Returned or uncertain stock sitting on the same shelf as sellable stock causes trouble at inspection and in trade alike.
The dispatch side
Two things are measured in dispatch: accuracy and speed. Sending the wrong product costs more than sending it late, because the return and the resend both fall on you.
Separating picking from checking reduces that error markedly: one person picks, another checks before dispatch. Even in a small operation, splitting those steps makes sense.
The clauses to look at in a supplier agreement
A distributor’s commercial strength comes from the terms of the agreement struck with the manufacturer.
Territorial exclusivity, the annual purchase commitment, return and stock protection terms, and the price revision arrangement are the decisive clauses. An exclusive territory gives you strength, but it comes with a commitment; fail to meet it and both the authority and the capital are at risk.
The stock protection clause is the item most often passed over: when prices fall, the value of the stock in your hands falls with them. If the agreement does not say in writing how that is met, the loss is yours alone.
In Short
- Two items set the pace: the responsible manager and the brand authorisation contract
- The product group decision changes storage, capital and the responsible manager’s profile together
- Starting with a wide portfolio makes the warehouse set-up heavier than it needs to be
- In distribution a company structure is all but compulsory
- Four headings must be settled in the contract: exclusivity, minimum purchase, price structure, recall cost
- Do not sign a minimum purchase commitment without knowing your sales capacity
- The points of sale you supply must hold authorisation certificates too
- The system record and the accounting record must agree
- Taking dealers on grows the volume but does not spread the chain’s liability
- The quarantine area is the section most often missing from a warehouse
- Without a stock protection clause, the loss from a price fall is yours alone
For a neighbouring branch see our medical e-commerce article as well.
Quick Glossary
Exclusivity: the right to distribute a brand through a single hand in a given territory. Minimum purchase commitment: the lowest volume promised over a given period. The chain: the recorded path of a product from manufacturer to user. Reconciliation: comparing two records and bringing them into agreement.
Next Step
Let’s map out your distribution set-up and your contract headings together: consultation request form.
Frequently Asked Questions
Updated: September 2026
Sık Sorulan Sorular
The standard workplace documents, a sales centre authorisation certificate, system registration, a responsible manager and a brand authorisation contract.
In practice it is hard; brands and corporate customers expect a company structure.
Yes, if you sign it without knowing your sales capacity; the volume you cannot sell stays with you as stock.
Yes. Selling a medical device to an unauthorised point means the chain breaks at your link.
Partitioning and storage conditions rather than floor area; your product group decides it.
They should not; when the two do not agree, stock discrepancies break traceability.
It should be written into the contract; without that, a dispute between the parties follows.
Not essential, but being the only one in a territory eases price pressure; keep its limits clear in the contract.
Two to three months if the responsible manager and the brand contract are ready; without those two the timing stretches.