If you’re moving a medical device into Latin America after FDA clearance or CE marking, you’ll encounter two distinct compliance roles that are easy to confuse: the importer of record (IOR) and the in-country registration holder. Treating them as interchangeable is one of the most common (and costly) structural mistakes in LATAM medtech market entry.
IOR and registration holder: what each role actually means
The importer of record is the locally established legal entity accountable for a specific shipment entering the country. The IOR files the customs declaration, ensures the physical device and its documentation match, settles applicable import duties and VAT/IVA, and coordinates any import authorization required by the health authority to clear a regulated device. If something is wrong at the port, the IOR is liable.
The in-country registration holder is a different role entirely. It’s the entity named on the sanitary registration issued by the national regulator, and that registration is the legal permit that allows a medical device to be marketed and sold at all. Depending on the country, this role is called the titular del registro (Colombia, Mexico), detentor de registro (Brazil), Mexico Registration Holder or MRH (Mexico/COFEPRIS context), or Argentina Authorized Representative (AAR). Each term maps to the same core function: ownership of the regulatory license that controls market access.
The two gates every device must pass through
Getting a device into Latin America means clearing two separate gates.
Gate one is customs. The IOR handles entry paperwork, tariff classification, import duties, any health-authority-issued import permits, and the recordkeeping that makes future audits manageable. A mismatch between the named importer on the customs filing and the entity authorized under the sanitary registration can trigger a customs hold that no amount of follow-up phone calls will quickly resolve.
Gate two is the health authority. The registration holder controls the sanitary registration and, in multi-importer regimes, decides which importers and distributors are authorized to operate under it. Post-market obligations flow through this role: vigilance reporting, renewals, labeling amendments, and any configuration changes that require a registration update.
Getting gate one right while ignoring gate two sets up a market-access problem the moment you want to change distributors or enter a new sales channel.
What separates multi-importer markets from single-IoR markets
This is the structural distinction that shapes your entire LATAM commercial strategy. bioaccess® identifies two regulatory archetypes across the region (bioaccess® country-by-country guide, June 2026):
In a multi-importer model, one sanitary registration can list multiple named importers. The registration holder adds or removes importers without re-registering the device. Switching a commercial partner becomes an administrative amendment rather than a full regulatory restart.
In a single-IoR model, the registration is bound to one named entity that serves as both registration holder and importer of record. Multiple distributors can still operate downstream commercially, but at the regulatory level there’s only one accountable party per registration.
The practical implication: if your distributor holds the registration in a single-IoR market, they control your market access. That’s the “registration hostage” problem. When contract negotiations turn adversarial, the distributor can use registration ownership as leverage over pricing, renewal timelines, or exclusivity terms. A neutral registration holder that doesn’t participate in commercial distribution eliminates that leverage entirely.
How five key regulators structure these roles
Brazil (ANVISA): RDC 751/2022 names a single detentor de registro, but ANVISA explicitly permits the detentor to authorize multiple importers under one registration. Adding or removing an importer doesn’t require re-registering the device. This is a multi-importer market.
Mexico (COFEPRIS): The MRH owns the COFEPRIS sanitary registration and bears full product compliance accountability in Mexico. The MRH can add multiple distributors and importers to a single registration (MedEnvoy, August 2026; COFEPRIS/gob.mx). A distributor can hold the MRH designation, but giving a commercial partner that control creates dependency that can be difficult to unwind.
Colombia (INVIMA): INVIMA explicitly contemplates “un titular con varios importadores” on a single registro sanitario. The titular controls the importer list. Multi-importer model.
Argentina (ANMAT): The AAR is simultaneously the registration holder and the importer of record under Disposición ANMAT N° 64/2025 (which replaced Disposición 2318/2002). One AAR per registration, no splitting the roles. Strictly single-IoR.
Ecuador (ARCSA): Per Resolución ARCSA-DE-2023-033-AKRG, the sanitary registration must be applied for by a locally registered Ecuadorian company, which becomes the sole registration holder. Single-IoR model.
A quick decision framework before you appoint anyone
Before signing with a registration holder or IOR service provider in any LATAM country, work through four questions:
- Is this country a multi-importer or single-IoR market for your device class? The answer determines how much flexibility you have to change commercial partners later.
- Who will hold the registration in the contract, and what are the transfer or termination terms? A registration held by a commercial distributor with no documented transfer path is a liability.
- Can the partner support both the shipment-level compliance function (IOR) and the license-level compliance function (registration holder) in single-IoR markets? If not, you need two providers coordinating tightly.
- What’s the documented path to add or remove an importer, or to transfer the registration? Get that in writing before you sign anything.
Common mistakes that create customs holds and regulatory lock-in
Assuming IOR and registration holder are the same thing because one vendor offers both is a structural error, not just a terminology confusion. The legal accountability for a shipment and the legal ownership of the sanitary registration are governed by separate frameworks and have separate consequences when something goes wrong.
Not verifying the country model before appointing a distributor-as-registration-holder is equally problematic. In a single-IoR market like Argentina or Ecuador, that decision is very difficult to reverse quickly. In a multi-importer market like Brazil or Colombia, you have more room to restructure, but only if the original registration holder cooperates.
One more operational failure worth calling out: import documentation that names an entity other than the one authorized under the sanitary registration. Customs authorities in LATAM cross-reference these, and the mismatch causes delays that compound into missed sales cycles.
Frequently asked questions
Is the customs broker the same as the IOR? No. A customs broker files paperwork on behalf of an importer but doesn’t carry legal accountability for the shipment’s compliance. The IOR is the legally responsible party. The broker is an agent.
Do you need a separate IOR designation for every shipment? It depends on the country’s framework. In some markets, an import authorization from the health authority covers multiple shipments under one registration. In others, shipment-level permits are required. There’s no single LATAM-wide answer.
Can a distributor own the MRH registration in Mexico? Yes. COFEPRIS doesn’t prohibit it. But if the distributor holds the MRH and the commercial relationship deteriorates, transferring the registration requires the current holder’s cooperation, which they may not provide on your preferred timeline.
What happens when you change distributors in a multi-importer market vs. a single-IoR market? In a multi-importer market (Brazil, Colombia, Mexico), the registration holder files an amendment to add the new importer or remove the old one, without re-registering the device. In a single-IoR market (Argentina, Ecuador), a full registration transfer process is required, which takes considerably longer and depends on regulatory process timelines and the cooperation of the outgoing party.
bioaccess® supports medtech companies navigating LATAM market entry by serving as a neutral registration holder in coverage countries, separating regulatory control from commercial distribution so companies retain the ability to appoint, change, or expand their distributor networks without triggering a registration crisis. If you’re mapping your device’s IOR and registration holder structure across multiple LATAM markets, a country-by-country assessment of which model applies to your device class and portfolio is the right starting point. Reach out to the bioaccess® market access team to get that mapping done before you sign your first distribution agreement.
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