Who holds the registration: the clause that decides your exit.
In most markets outside the EU and the US, a foreign device company cannot hold its own registration. A local company holds it for you. Who that company is decides whether you can change distributors in year three, and what a buyer pays for your company in year five.
The question nobody asks on day one
The first distributor contract is signed in a hurry. The device is cleared, the home market is working, a distributor at a trade show says they can open Saudi Arabia or Brazil, and the regulator wants a local name on the file. The distributor is local. Their name goes on it. Nobody argues, because at that point everyone wants the same thing, which is the first order.
The registration then sits quietly for years. It only matters on the day you want something the distributor does not want: a second partner in the same market, a replacement, or a sale of the company. On that day you find out that you are not ending a commercial relationship. You are asking the regulator's counterparty for permission to leave, and the counterparty is the person you are leaving.
Emergo, which earns its living holding registrations for manufacturers, puts the Mexican version plainly: changing distributors is hard because your distributor "now effectively owns your registration". The same logic applies in a bunch of markets, and the fix is the same everywhere. Decide who holds it before the first order, and write it down.
Who can hold it, market by market
The table is a map, not legal advice. Rules change and the detail is per device class, so confirm with the regulator or a local representative before you sign. The pattern is what matters: where a local holder is required, you choose between the distributor and an independent holder, and the choice is yours only while you still have something they want.
| Market | Who holds the registration | Where the distributor fits | What to watch |
|---|---|---|---|
| GCC | A locally licensed company. In Saudi Arabia the SFDA licenses an authorised representative; the UAE, Bahrain, Oman, Qatar and Kuwait each require a local agent or representative. | Usually the importing distributor by default, because it already holds the import licence. | The authorised representative and the distributor are often the same company unless you separate them on purpose. Independent representatives exist in every Gulf market. |
| EU | The manufacturer, registered in EUDAMED. A non-EU manufacturer appoints an EU authorised representative, named on the label. Importers are registered EUDAMED actors; distributors are not. | A distributor can also be your importer of record, which is a separate legal role with its own liability. | Actor registration in EUDAMED has been mandatory since 28 May 2026. Keep the authorised representative independent of the sales channel; changing it means relabelling. |
| US | The manufacturer registers its establishment and lists the device with the FDA. A foreign manufacturer names a US agent. Initial importers register in their own right. | The importer is on file with the FDA, but the clearance belongs to the manufacturer. | The lowest exposure of the seven. The risk is the importer on file and labelling, not ownership of the clearance. |
| Canada | The manufacturer holds the device licence for Class II to IV devices. Importers and distributors hold a Medical Device Establishment Licence (MDEL). | The distributor's MDEL is theirs, your device licence is yours. | An MDEL holder is replaceable. Confirm the device licence is in your name, not applied for by the distributor. |
| Australia | A sponsor, which must be an Australian resident or company, includes the device in the ARTG. | Many distributors act as sponsor. | The ARTG entry belongs to the sponsor. If the distributor is the sponsor, they hold market access. Independent sponsors are available. |
| Brazil | ANVISA issues the registration to a Brazilian legal entity, the registration holder. | The distributor is the holder unless you appoint an independent one. | Changing the holder is a regulatory process, not a signature. Decide this before the first submission, because the dossier follows the holder. |
| Mexico | COFEPRIS issues the sanitary registration to a Mexican Registration Holder (MRH). | The distributor is the obvious MRH and often takes the role without anyone discussing it. | The market where the problem is best documented. An independent MRH with a transfer letter on file keeps every distributor replaceable. |
What goes wrong when the distributor holds it
You cannot switch. The replacement distributor cannot import a single unit until the registration moves or a new one is granted. New registrations take months and cost money, and in the meantime the old distributor is still selling your stock.
You cannot add. A second distributor in the same market needs to import under the same registration. The holder decides whether that happens, and a holder that is also your exclusive partner has every reason to say no.
The transfer has a price. Where transfer is possible, it needs the holder's signature. The signature arrives with a number attached, or with a silence that costs you a selling season. Neither is bad faith. It is a company realising it holds an asset it never paid for.
Vigilance and recalls run through them. The regulator talks to the holder, not to you. If the relationship has soured, your post-market obligations are in the hands of someone you are in dispute with.
The acquirer prices it. Due diligence on a device company goes market by market through the registrations. Where the distributor holds them, the buyer sees revenue that depends on a third party's goodwill and discounts it, or asks you to fix it before closing, which puts you back at the table with the holder, in a hurry, with a deadline the holder can see.
The three clauses that fix it
1. Holder of record. Wherever the law allows, the registration is held by you or by an independent local representative you appoint and pay. The distributor is appointed under that registration and can be replaced without touching it. Where the law requires the importer to hold it, the contract names the distributor as holder on your behalf, acting on your instructions, with no right to register, amend or cancel without your written consent.
2. Transfer on termination. On expiry or termination for any reason, the holder transfers every registration, licence and listing to you or your nominee within a fixed period, cooperates with the regulator, signs what the regulator needs, and bears no cost beyond its own time. Back it with an irrevocable power of attorney signed at the start, and a daily penalty for delay. A clause without a power of attorney is a request.
3. Dossier and data ownership. The technical file, test reports, certificates, labels, translations and every letter to and from the regulator belong to you. Copies are delivered on request and in full on termination. Without the dossier, a new holder starts from zero even when the registration transfers cleanly.
Put these in the first contract. Leverage is highest before the first order and lowest at the moment you want to leave. A distributor that refuses all three before you have shipped a box has told you something useful.
How to check in the Index
The Bastion Hale Distributor Index is built from the public registries that license these companies, so it shows the holder landscape of a market before you meet anyone in it.
- Search your device and the market. The result shows how many licensed establishments the market has and the split between registration holders, authorised representatives, importers and distributors, as the registry labels them. A market with many holders and few importers has a different structure from one where every importer is also a holder.
- Open the country page. Each one has a section on who holds the registration in that market, with counts by role, and the top establishments by size.
- Look up the candidate. The profile shows the roles the registry gave them, how many products are registered behind them and how many principals they represent. A candidate that holds registrations for a dozen principals has done transfers before; ask how the last one went, and ask the principal who left.
- Read the source line. Every record shows the registry it came from and the date it was last seen, so you know how fresh the picture is. Gulf coverage is still partial in the current build: Saudi Arabia shows a sample of its register and Bahrain's list is dated 2023.
The Index does not show who holds the registration for your product. For that, read the name on the certificate. If you have never seen the certificate, that is the first thing to ask for this week.
Questions people ask
Can a foreign manufacturer hold its own registration in Saudi Arabia or the UAE?
Not directly. In Saudi Arabia the SFDA licenses a local authorised representative to hold the device registration on the manufacturer's behalf, and the UAE requires a locally licensed agent. The holder can be your importing distributor or an independent representative whose only job is to hold it. The choice is yours, and it is made in the first contract.
What is the difference between an authorised representative and a distributor?
An authorised representative or registration holder is a regulatory role: the local legal entity the regulator deals with, named on the registration and often on the label. A distributor is a commercial role: the company that buys, stocks and sells. One company can do both, and that is where the problem starts, because ending the commercial relationship does not end the regulatory one.
Can a distributor refuse to transfer a registration it holds?
In practice, yes, or it can set a price for cooperating. The registration is issued to the holder, and most regulators need the holder's cooperation to transfer or cancel it. Without a transfer clause, a power of attorney and a deadline in the distribution agreement, you are negotiating from the weaker side at the moment you most want to leave.
Does the Distributor Index show who holds my registration?
It shows who is licensed to hold registrations in each market, who is licensed only to import, and for each establishment how many products and principals sit behind it, with the registry source and date. It does not show the holder of your specific product. For that, check the regulator's product register or ask your distributor for the certificate, and read the name on it.
Find out who holds it in your next market.
Search the Index free to see the holder landscape in any of 111 markets. Or spend half a day with me: a ranked market list, the registration holder picture per market and three named distributors, or a clear no.
Sources: Emergo by UL on Mexico registration holders and independent representation; MedEnvoy on the EU importer role; HPRA on mandatory EUDAMED modules from 28 May 2026; the Bastion Hale Distributor Index build of 22 October 2026 and its source notes. Registry data; Bastion Hale does not vouch for any establishment. This article is not legal advice.