Who holds your product registration, and why it decides whether you can change distributor

Most suppliers spend their negotiating capital on exclusivity, territory and minimum volumes. Those are the terms that feel commercial. Meanwhile a clause further down the agreement quietly decides something more fundamental: whether, three years from now, you are free to replace a distributor who is not performing, or whether replacing them means starting your regulatory approval again from zero and losing a year of sales while you do it.

That clause is the one that says who applies for, and whose name appears on, your product registration.

The reason this gets conceded so easily is that it rarely looks like a negotiation. Someone has to file the paperwork, the distributor is the one with the local entity and the regulatory people, and it is genuinely easier to let them do it. The supplier is not giving anything away on purpose. They simply never priced what they were handing over.

1. Three different things called “registration”

People use one word for three mechanisms that behave completely differently. Getting them apart is most of the work.

The practical consequence: a manufacturer of building materials and a manufacturer of pharmaceuticals, selling into the same country through the same kind of distributor, can be in completely different positions when the relationship goes wrong. One can walk away in a fortnight. The other may be unable to walk away at all.

2. The question that actually matters

It is tempting to ask “can I hold the registration myself?” In most markets the answer is no, and it is the wrong question. Regulators want an entity inside their jurisdiction that they can inspect, fine and hold responsible for recalls. That requirement is near-universal and it is not unreasonable.

The second question, close behind: if the registration does end up in a distributor’s name, what does it take to move it? There are three possible answers, and the gap between them is enormous.

• You can move it unilaterally. You revoke the authority you gave, appoint someone else, and notify the regulator. Painful but survivable.
• You need the incumbent’s written consent. This is the dangerous one, because the consent is worth a great deal to them at exactly the moment they are least inclined to give it.
• There is no transfer route. You re-register from the start under a new holder and accept the gap. In some classes this is simply how the regime works.

3. Five markets, compared

These five are not a ranking. They are five genuinely different designs, and together they cover most of the shapes you will meet. All positions are as at October 2026 and several changed recently.

Saudi Arabia — one country, three different answers

Saudi Arabia is the clearest demonstration that product class matters more than country. The same manufacturer gets three different outcomes depending on what they make.

Medical devices are the most supplier-friendly arrangement in any of these five markets. Under the SFDA’s establishment licensing requirements, every establishment must be a legal entity in the Kingdom, so the authorised representative is necessarily Saudi — but the marketing authorisation itself stays in the manufacturer’s name, with the representative named alongside it in a delegated capacity. A separate representative licence is needed for each manufacturer, and importers hold their own licences independently. Appointing a different distributor therefore does not disturb the authorisation at all. Appointing an independent representative rather than your distributor is normal practice, not a clever workaround.

Pharmaceuticals sit differently. The authorisation holder is expected to be the genuine product owner — so usually the foreign manufacturer — but filings must go through a locally established agent or the manufacturer’s own scientific office, and that agency relationship is registered with the Ministry of Commerce. Transferring to a new holder is treated as a variation requiring the regulator’s acceptance, and the submission includes a copy of the agreement between the parties. There is no separate no-objection letter in the published guidance, but the agreement requirement does much the same work.

Food, cosmetics and industrial goods run the other way. Registration on the SFDA’s portal is done by the importer, and the importer’s commercial registration details appear on the product label — so changing distributor means relabelling at minimum. For goods under the SABER conformity scheme there is no transferable holder concept at all: a new importer simply obtains their own certificate of conformity, which sounds restrictive and is actually the easiest exit of the three.

United Arab Emirates — a regime being deliberately unlocked

The UAE has changed more than any of these five, and most guidance online is now wrong. Medicines and medical devices moved from the Ministry of Health to the new Emirates Drug Establishment under Federal Decree-Law No. 38 of 2024, in force from January 2025. Anything referring to MOHAP drug registration describes a system that no longer exists.

The substantive change matters more. Article 22 of that law requires a marketing authorisation holder to appoint at least two importers, and the regulator activated the mechanism in February 2026 with the explicit aim of breaking single-agent monopolies on medical products. A single exclusive importer arrangement is no longer the compliant default for new registrations. For a supplier worried about dependence on one partner, a regulator has effectively legislated the problem away — in one product class, in one country.

The holder still has to be a locally licensed establishment, but that can be a marketing office or regulatory services entity rather than your trading distributor, and free zone entities can act as representative for devices. The separation is available and it is the standard structure for suppliers who have thought about it.

Running alongside all this is the Commercial Agencies Law, rewritten by Federal Decree-Law No. 3 of 2022 and in force since June 2023. Registering an agency with the ministry is optional, and what it buys the agent is significant: statutory exclusivity and the ability to block parallel imports at customs. A registered agency combined with a registration held in that agent’s name is the strongest lock-in available anywhere in this article — they can stop your goods at the border and control your dossier at the same time. The transitional protections for older registered agencies have now largely expired, which has made this a live question rather than a historical one.

Indonesia — where the incumbent holds the key

Indonesia’s reputation as the hardest market in Asia for this is broadly deserved, though the detail is more specific than the reputation suggests.

For pharmaceuticals, the registrant must be a licensed Indonesian pharmaceutical manufacturer. Not a distributor, not an agent — a licensed manufacturer. The registration regulations contain no transfer article at all, and a change of registrant is expressly excluded from the renewal route, which means a change of holder is a fresh registration. There is a meaningful carve-out: an affiliate of the foreign principal does not need the principal’s written authorisation to register, which is one of several reasons suppliers serious about Indonesia end up incorporating there.

For medical devices, the authorisation holder must hold a distribution licence, and the regime operates a one-trademark-one-distributor rule. The critical mechanism is in the renewal and variation process for imported products: the file requires a stamped declaration from the incumbent that they are willing to release the agency. If the incumbent declines to sign it, there is no unilateral route. You wait for the registration to expire and re-register, with whatever market gap that creates. Official processing runs from around 45 days for the lowest risk class to 120 days for the highest, before any dispute.

That single document is the clearest example in this article of why the clause matters. It costs nothing to sign, it is worth a great deal to withhold, and the moment you need it is the moment your relationship has broken down.

Food and cosmetics follow the same shape — a locally licensed importer holds the registration and there is no documented transfer mechanism, so a new importer re-registers. For industrial products under mandatory standards, the certificate is issued to an official representative who must also act as importer and hold a recorded trademark licence, which is arguably tighter than the health regimes rather than looser.

Nigeria — a mandate you can revoke

Nigeria looks worse on paper than it behaves in practice, and the distinction is instructive.

NAFDAC does not register products to non-resident entities. Foreign manufacturers register through a local representative, and the certificate is issued in that representative’s name. On the face of it, that is the trap this article is about.

What changes the picture is the mechanism underneath. The representative’s authority comes from a notarised power of attorney issued by the manufacturer. To change representative, the manufacturer issues a notarised instrument revoking the original power of attorney and a new one appointing the replacement. The incumbent’s consent is not part of the published process — the manufacturer acts unilaterally — and NAFDAC’s tariff carries a line item for change of agency. It is an administrative step, not a negotiation.

There is also a structure here that does not have a clean equivalent in the other four markets: custodial holder companies that exist specifically to hold registrations in their own name and issue no-objection letters allowing the manufacturer’s distributors to import. It is a service industry built on exactly the problem this article describes, which tells you how common the problem is.

Industrial goods invert the pattern again. Under the Standards Organisation of Nigeria regime the durable product certificate is issued to the exporter and held offshore, while the importer holds only per-shipment certificates tied to their own tax identification number. The manufacturer keeps the asset that matters. Among everything in this article, that is the most supplier-favourable design of all, and it is in the market with the most fearsome reputation.

One caution specific to Nigeria: registration interacts directly with payment. The regulator’s permit system is integrated with the central bank’s import documentation, so a valid licence in the representative’s name is what allows your distributor to obtain foreign exchange and actually pay you. In January 2026 the central bank had to issue a temporary dispensation allowing expired NAFDAC licences to be used for import documentation during a platform migration — a reminder that lapsed regulatory paperwork stops the money, not just the goods.

Myanmar — where the registration is the least of it

Myanmar is included because it shows the limits of thinking about this as a contract problem.

The formal position is restrictive and clear. Myanmar’s own notification to the WTO states plainly that import licences are not transferable between importers. Pharmaceutical registration requires a local representative resident in Myanmar, and the sequence runs registration certificate, then importation approval, then import licence — three dependencies, all local. Under the companies law a business with more than 35% foreign shareholding counts as foreign, and foreign-owned companies may only import a short list of goods that includes hospital equipment and construction materials but excludes pharmaceuticals, food and cosmetics. For those classes your holder must in practice be a citizen-controlled company. For hospital equipment and construction materials, a foreign-owned local entity is a genuine route to holding your own import rights.

But the binding constraint today is not the registration. From January 2026, import licence applications may be filed only through the electronic system, lapse automatically if not approved within 180 days, and are limited to one application per tariff code per calendar month — which caps how many product lines a distributor can physically process. Alongside that, foreign exchange is rationed under an export-first policy, and in practice licences go to importers who can demonstrate export earnings.

So the diligence question in Myanmar is not “will this distributor hold my registration hostage”. It is “can this distributor obtain licences and source hard currency at all”. A perfectly drafted registration clause is worth nothing if your partner cannot pay you.

4. What the comparison shows

Three things come out of setting them side by side.

Product class predicts lock-in better than country does. This is the finding most likely to be useful and the one most often missed, because advice is usually organised by country. A device manufacturer in Saudi Arabia and a food manufacturer in Saudi Arabia face completely different exposures. Meanwhile a device manufacturer in Saudi Arabia and a device manufacturer in Nigeria — two markets nobody would group together — are in broadly similar positions, because both regimes keep the durable asset with the manufacturer. If you sell across several categories, your registration risk is not a country map. It is a grid.

Conformity regimes are friendlier than health regimes. Construction materials, electricals and industrial goods generally run on certificates that a new importer can simply obtain for themselves. Nigeria goes furthest, leaving the durable certificate offshore with the exporter. Suppliers in these categories often assume they have the same problem as pharmaceutical companies and spend negotiating capital they did not need to spend.

The expensive variable is consent. Across all five markets the difference between a difficult exit and an impossible one is whether the process requires a signature from the party you are leaving. Indonesia’s device release letter is the clearest case. Nigeria’s revocable power of attorney is the clearest counter-example. When you are reading a regime for the first time, that is the thing to find out first, before timelines and before fees.

5. Before you sign

One sentence is worth more than most of the rest: the distributor agrees, at the supplier’s request and at any time, to do everything necessary to transfer the registration to the supplier or its nominee. Put it in, give it a deadline, and attach a consequence.

6. If you have already signed

Most suppliers reading this are not negotiating a fresh agreement. They are looking at an existing arrangement and wondering how exposed they are.

1. Establish the facts before the strategy. Get the registration certificate itself, not a summary. Whose name is on it, when does it expire, and which entity in the distributor’s group holds it? Trading groups often register through a sister company, which matters if you are relying on contract terms that bind only the signatory.
2. Find out what the transfer route actually is in your class. Not in your market generally — in your class. Saudi Arabia alone has three answers.
3. Work out your expiry date. Where no transfer route exists, the expiry of the current registration is your natural exit point, and re-registration under a new partner can be prepared in advance so the gap is as short as possible.
4. Use renewals as leverage. Renewal is a moment the distributor needs something from you — the manufacturer’s letter, the plant certificate, the dossier update. It is the most natural point to agree the transfer wording you did not get at signature.
5. Consider a holder that is not a distributor. Where the market allows it, moving the registration to your own local entity or an independent holder converts a structural problem into an administrative one, permanently. It costs money. It costs less than a lost year.

General commercial guidance, not legal or regulatory advice. The positions described were researched against regulator publications and legal commentary current in October 2026; several of these regimes changed within the preceding two years and some are still changing. Requirements also vary by product within a class. Take local regulatory and legal advice on any specific product before relying on any of this.