Short answer: the importer of record (IOR) answers for a shipment, while the registration holder answers for the license. The IOR is the local legal entity responsible for a specific consignment at customs. The registration holder is the entity named on the sanitary registration, the permit that lets a medical device be sold in the country at all. In some Latin American markets one registration can carry several importers. In others, the holder and the importer have to be the same entity. Which model applies decides who controls your market access when you change distributors.
This page brings together our IOR-vs-holder guide and our country-by-country importer of record reference. Every country rule below names the regulation it comes from.
The two roles, side by side
| Importer of record (IOR) | Registration holder | |
|---|---|---|
| What it is accountable for | A specific shipment: the customs declaration, tariff classification, duties and VAT/IVA, and any import authorization the health authority requires | The sanitary registration itself: who may market the device, renewals, label and configuration changes, and technovigilance |
| Local names | Importador, importador autorizado | Titular del registro (Colombia, Mexico, Peru, Ecuador), detentor do registro (Brazil), Argentina Authorized Representative |
| Liability when something goes wrong | At the port: a held or rejected consignment | In the market: a suspended, cancelled or contested registration |
| What changing it involves | In multi-importer markets, an amendment to the registration’s importer list | A formal transfer that the current holder has to sign |
A customs broker is neither of these. The broker files paperwork as the importer’s agent but does not carry the importer’s legal accountability.
The two gates every device passes through
Gate one is customs. The IOR handles the entry filing, duties and any import permit, and it keeps the records that later audits rely on. If the importer named on the customs filing is not an entity authorized under the sanitary registration, the shipment can be held.
Gate two is the health authority. The registration holder owns the registration and carries the post-market duties: vigilance reporting, renewals, labeling amendments and any change that needs a registration update. In multi-importer markets it also decides which importers are listed. Solving gate one while ignoring gate two leaves a problem that surfaces the day you want to change distributors.
Multi-importer markets vs. single-IoR markets
In a multi-importer market, one registration can name several importers, and the holder adds or removes them by amending the registration, without re-registering the device. In a single-IoR market, the registration is tied to one local entity that is both holder and importer. Distributors can still sell downstream, but only one party is accountable to the regulator.
The practical consequence: if a distributor holds your registration, especially in a single-IoR market, that distributor controls your market access. We call this the registration-hostage problem. A neutral holder that does not sell your product removes that leverage.
How the main regulators structure the roles
Brazil (ANVISA): one detentor, importers authorized under it
RDC 751/2022 regulates device regularization, and each registration or notification has a single detentor, which must be a company licensed in Brazil. The detentor can authorize other licensed companies to import under its registration. Changing the detentor itself is a transfer of titularidade under RDC 903/2024, which replaced RDC 102/2016. The transfer is allowed only after a corporate or commercial operation, the petitions are due within 180 days, and products regularized by notificação cannot be transferred (Articles 26 and 28).
Mexico (COFEPRIS): the titular can list several distributors and importers
The registro sanitario is granted under the Reglamento de Insumos para la Salud, and the titular (often called the Mexico Registration Holder) carries product compliance in Mexico. One registration can support several distributors and importers. Moving the registration to a new titular is a cesión de derechos. It is filed as a modification under homoclave COFEPRIS-2022-022-003, it needs a notarized contract, and it must be notified within 30 business days.
Colombia (INVIMA): “un titular con varios importadores”
INVIMA’s own guidance refers to a registration with “un titular con varios importadores” (one holder with several importers) and makes the titular responsible for the UDI-DI and semantic-standard report under Resolución 1405 de 2022. Under Decreto 4725 de 2005, the manufacturer authorizes a Colombian-domiciled entity to import and, where applicable, to be the titular. Each importer must have its own corporate purpose covering device import, and INVIMA requires a storage and conditioning certificate (CCAA) where it applies. A change of titular is an automatic modification under Article 30 of Decreto 4725, as substituted by Decreto 582 de 2017, and it needs a cesión signed by both parties.
Peru (DIGEMID): the titular must be a licensed droguería or laboratorio
Under the device regulation, DS 016-2011-SA as updated by DS 020-2024-SA, only a pharmaceutical establishment authorized as a droguería or a device laboratorio can apply for a device registro sanitario. The registration lets its titular import, store, distribute and sell the device. A registration can be transferred only by its titular and only to another qualified establishment (Article 8). An independent licensed droguería can therefore hold the registration in place of a distributor.
Argentina (ANMAT): holder and importer are the same entity
Device registration follows Disposición ANMAT 64/2025, which incorporated MERCOSUR Resolución GMC 25/21 and repealed Disposición 2318/2002 and its consolidated text, Disposición 1285/2004. It took effect for new registrations on January 21, 2025. The local registrant is both the registration holder and the importer, so there is one Argentina Authorized Representative per registration. Argentina is a strictly single-IoR market.
Ecuador (ARCSA): one titular per certificate
ARCSA’s device rules, now consolidated in Resolución ARCSA-DE-2026-003-DASP, issue the certificado de registro sanitario in the name of a single titular. That titular is legally and technically responsible for the product’s quality and safety in Ecuador. The applicant can be the manufacturer, its legal representative or an authorized distributor in Ecuador. Treat Ecuador as single-holder.
For the other markets, including Paraguay, the Dominican Republic, Panama, Costa Rica, Central America and the Caribbean, see the importer of record country reference and the medical device registration guide.
Four questions to answer before you appoint anyone
- Is the country multi-importer or single-IoR for your device? The answer sets how much room you have to change partners later.
- Who will hold the registration, and what are the transfer terms? A registration held by a distributor with no written path to transfer it is a liability.
- Can one partner cover both roles where the country requires it? If not, you need two providers working closely together.
- What is the written procedure to add or remove an importer, or to transfer the registration? Agree on it before signing. Every transfer route in the region needs the current holder’s signature.
Common mistakes
- Treating IOR and holder as the same thing because one vendor offers both. They are governed separately and fail separately.
- Appointing a distributor as holder without checking the country model. In Argentina or Ecuador that decision is hard to reverse quickly.
- Import documents that name an entity not authorized under the registration. Customs and health authorities cross-check them.
- Leaving the transfer clause out of the distribution agreement. When the relationship ends, a holder who won’t sign leaves you with a new registration and a supply gap.
If a holder change is already on the table, our guide to transferring a medical device registration to a new holder in Brazil, Mexico, Colombia and Peru walks through each agency’s procedure. The country holder guides for Brazil, Mexico and Colombia cover the first filing.
Frequently asked questions
What is the difference between an importer of record and a registration holder?
The importer of record is legally responsible for a specific shipment clearing customs. The registration holder owns the sanitary registration that allows the device to be marketed, and it carries the post-market obligations. In single-IoR markets such as Argentina, one entity does both.
Is the customs broker the importer of record?
No. The broker files on the importer’s behalf as an agent. The importer of record keeps the legal accountability.
Can one registration have several importers?
In Colombia, Mexico and Brazil, yes: the holder authorizes or lists additional importers without re-registering the device. In Argentina and Ecuador, the registration is tied to a single local holder.
Can a distributor hold my registration?
Usually, yes. If the relationship ends, though, moving the registration needs that distributor’s signature in every major market. A neutral holder avoids that dependency.
What happens when I change distributors?
In a multi-importer market, the holder amends the registration to add the new importer and remove the old one. If the distributor was also the holder, you need a formal transfer, such as a cesión de derechos in Mexico or Colombia or a transfer of titularidade in Brazil, signed by the outgoing holder.
Where bioaccess® fits
bioaccess® acts as a neutral registration holder across our Latin American coverage. Because we keep regulatory control separate from commercial distribution, you can appoint, change or add distributors without a registration crisis. To map which model applies to your device in each target market, start at bioaccess® market access or contact our team.
Sources
- ANVISA, RDC 751/2022 (device regularization) and RDC 903/2024 (transfer of titularidade), Articles 26 and 28
- COFEPRIS, Reglamento de Insumos para la Salud; modification procedure COFEPRIS-2022-022-003 (cesión de derechos)
- INVIMA, Decreto 4725 de 2005 (Article 30, as substituted by Decreto 582 de 2017); INVIMA guidance on the estándar semántico under Resolución 1405 de 2022; INVIMA medical device registration requirements
- DIGEMID, DS 016-2011-SA (Articles 8 and 19, as updated by DS 020-2024-SA)
- ANMAT, Disposición 64/2025 (MERCOSUR Resolución GMC 25/21), published in the Boletín Oficial on January 13, 2025
- ARCSA, Resolución ARCSA-DE-2026-003-DASP (device registration technical rule)
Julio G. Martinez-Clark, CEO, bioaccess®