The Forgotten Risk of Imports: Who Is the Registration Holder?

A question that is rarely asked

There is one question that is rarely asked in meetings about importing medical devices, supplements or diagnostics. Everyone talks about margins, logistics and delivery times. And hardly anyone asks: who is the registration holder, meaning in whose name the product is registered?

It sounds technical, almost boring. But it can decide whether, after two years of successful business, you are left with nothing or with something that is yours. Product registration takes significant capital, time and specialized compliance work, and many importers never check who the registration holder is or what happens to the registration if the relationship ends.

The rules and the terms depend on the type of product and on the country. For medical devices in Serbia there is a Register of Medical Devices and a holder of the entry in it. Check what applies to your product.

What it looks like in numbers (an imagined example)

Suppose the registration cost €15,000 and 9 months of work, and the products bring €400,000 of turnover a year at a 20% margin, which is €80,000 of margin a year.

If the supplier moves the registration to a competitor after two years, the distributor has by then earned €160,000 of margin and recovered the investment. But from then on the distributor loses €80,000 of margin a year, and stock of, say, €50,000 may be unsellable if the contract does not allow a sell-off.

If the contract only provides reimbursement of certification costs, the distributor receives €15,000, which is less than one year of future margin.

For your own case, take the figures from your own registration costs and turnover.

Questions to Check Before Signing

These are not ready-made contract clauses or legal advice, but questions worth thinking about before you accept the terms. The exact wording depends on your contract and the applicable rules.

Who is the registration holder, and is it legally possible for you to be the holder?

Who bears the cost of obtaining and maintaining it, and who reimburses it on termination?

Can the supplier transfer the registration to a new distributor, and on what terms?

May you sell off stock after termination, and for how long?

What happens to the documentation and data you prepared for the registration?

Before you invest in a registration for someone else's brand, describe your situation and investment plan to us. The report will show you the risks and options around who holds the registration.

Prepare questions before making a binding decision

Expert Consilium helps you examine business assumptions, risks and options before you make a decision. A business analysis of the terms shows what they mean for price, risk and flexibility.

Contact us: office@expertconsilium.com | expertconsilium.com

Informational business article. It does not constitute legal, tax, accounting, investment or other regulated advice.