One registration for a console and its disposables? System registration in Brazil (RDC 751) and Colombia (Decreto 4725)

A sponsor has a capital device (a console, a generator, a pump) and a line of single-use disposables that only work with it. Before budgeting Latin America, they ask me two questions. Can the console and the disposables go in as one system registration? And once that registration is granted, can the disposables be imported and sold on their own, as the recurring revenue they are, without a second file?

I’m Julio Martinez-Clark, CEO of bioaccess®. We run first-in-human studies and market access for medical device companies across Latin America, and in Brazil and Colombia we hold registrations independently of the distribution channel. This question has come up in several multi-country portfolio enquiries this autumn, so here is how the text of ANVISA’s RDC 751/2022 and Colombia’s Decreto 4725 de 2005 answers it, and where the plan usually breaks.

The short answer

Yes in both countries, with conditions. Brazil’s RDC 751/2022 Art. 3 says ANVISA grants notification or registration for families, systems and kits of medical devices. Colombia’s Decreto 4725 de 2005 Art. 28 lets several devices that are “empleados en conjunto conformando lo que se puede denominar un sistema o kit” share one registro sanitario. In both, the disposables can then be supplied under that registration if they are specifically listed in it. If a disposable reference number is not in the registration, it is not covered, no matter how obviously it belongs to the console.

The conditions are where projects lose months: component classification, GMP coverage of every plant, and how precisely the dossier lists the disposables.

Brazil: system, kit and accessory are three different things

RDC 751/2022 Art. 4 defines the terms, and the definition you file under drives the rest of the dossier.

• Sistema (Art. 4, XL): a set of compatible medical devices that relate to or interact with each other exclusively to achieve one intended purpose set by the manufacturer. A console with disposables designed only for it is the textbook case.
• Kit (Art. 4, XXVI): devices grouped into one sales unit for a specific use or procedure, from the same manufacturer or manufacturing group, whose components do not depend on each other to work. A procedure tray is a kit. A console that cannot run without its cartridge is not.
• Acessório (Art. 4, I): a product intended by its manufacturer to be used with one or more specific devices so they can be used as intended.

Filing a console-plus-disposables combination as a kit is a common mistake, and the definition itself rules it out: kit components are not interdependent. File it as a system.

Two provisions help with disposables. Art. 2 §10 exempts from separate notification or registration the accessories a manufacturer makes exclusively to integrate with its own already-registered devices, as long as the technical dossier contains information about them. Art. 2 §11 lets new accessories be added to the original registration, with a description of how they work, what they do and what they contain. The practical rule is simple: describe every disposable reference in the system dossier from day one, and add new ones by petition to the same registration rather than starting a new file.

The catch is classification. Under Art. 8 §1, when a device is meant to be used in combination with another, the classification rules apply separately to each one. Under Art. 8 §2, accessories are classified on their own, separately from the device they are used with. A Class II console paired with an implantable or invasive disposable does not make the disposable Class II. In practice, the system registration has to meet the requirements of its highest-risk component, and the dossier should state each component’s class and the rule behind it.

Then good manufacturing practice. Art. 24 makes approval of any petition to add products or models to a family, system or kit in risk classes III and IV dependent on publication of ANVISA’s Certificado de Boas Práticas de Fabricação (CBPF). If the disposables come from a different plant than the console, that plant needs to be inside the CBPF scope before ANVISA approves the system or a later addition. We covered how ANVISA handles CBPF across several plants in one CBPF or one per plant?

One more Brazil point: Art. 3’s sole paragraph says the grouping of products for notification or registration follows the rules of a specific ANVISA regulation. Check the grouping against those rules before you assume a component fits the system. An electromedical console also brings INMETRO certification and, if it has a radio, ANATEL homologation. Those run in parallel with the registration, not inside it. See INMETRO and ANATEL for medical devices in Brazil.

Can the disposables be sold alone in Brazil?

If they are registered as part of the system or added as accessories under Art. 2 §§10–11, yes. The disposables then carry the system’s registration number on their labeling and can be imported as resupply under the holder’s registration. RDC 751 Art. 2 §9 also exempts from separate registration presentations made up of two or more already-registered devices kept in their original individual packaging, provided the label carries each device’s registration number.

Colombia: one registro if the grouping test is met

Decreto 4725 de 2005 Art. 28 is titled “amparo de varios dispositivos médicos en un mismo registro sanitario.” It lets one registro sanitario cover devices that share risk class, use and generic name, belong to the same titular and manufacturers, and differ only in ways that do not significantly change the indication, or that are used together as “un sistema o kit.” The article ends with “según la clase de dispositivo médico,” so plan the classification of each component before you decide how to group them.

Two other parts of the decree matter for a console-plus-disposables system.

• What the registration shows. Art. 20 lists the content of a registro sanitario. Literal (l) covers observations, including “referencias, sistemas y subsistemas, modelos autorizados.” The references printed on the registro are what customs, INVIMA inspectors and hospital buyers check against. If a disposable reference is not listed, the shipment is a problem.
• Whether the console is “equipo biomédico.” Art. 2 defines equipo biomédico as an operational, functional device that combines electrical, electronic or hydraulic systems and subsystems, including its software. Equipment that falls under controlled technology gets a permiso de comercialización rather than a registro sanitario (Art. 29 and Art. 25), and Art. 25 (h) has the permit list the main systems and subsystems. Confirm early whether your console is in that category, because it changes the instrument and may mean the console and the disposables sit on different authorizations.

Art. 2 also defines “accesorio” much as Brazil does: a product the manufacturer intends to be used with a device so it can be used as intended. That is the right way to describe exclusive disposables in the technical file.

Can the disposables be sold alone in Colombia?

If each disposable reference is listed on the registro, yes. It can be imported under that registro by the importer named on it. Remember that the importer is a named field of the registration (Art. 20, literal j). If your resupply will come through a different importer than the console, that importer has to be on the registro first. We explained that filing in INVIMA change of importer on an existing registro sanitario. Adding a new disposable reference later is a modification of the registration, not a new one, as long as it fits the Art. 28 grouping.

Where system registrations go wrong

1. Filed as a kit instead of a system. In Brazil the kit definition excludes interdependent components.
2. Disposables described generically. “Compatible single-use cartridges” is not a reference list. Every catalog number, size and pack configuration you plan to sell needs to be in the dossier and, in Colombia, on the registro.
3. Component classes not argued. Both regimes classify components on their own terms (Brazil says it outright in RDC 751 Art. 8). Write out the class and rule for each component.
4. A second plant left out. Disposables made by a contract manufacturer or at a sister site need GMP coverage. In Brazil, for Class III/IV additions, ANVISA waits for the CBPF (Art. 24).
5. Labels that don’t carry the registration. Disposables sold alone still need Spanish (Colombia) or Portuguese (Brazil) labeling with the registration number and the local holder and importer data.
6. Different titular for console and disposables. Colombia’s Art. 28 requires the same titular and manufacturers. If a distributor registered the console in its own name years ago, the disposables cannot simply be added to your new file. Sort out the holder first.

Operator checklist

• Write a system description and compatibility statement in the IFU that names every component and reference number.
• Classify each component separately and record the rule (RDC 751 Annex I in Brazil; Decreto 4725 Art. 7 rules in Colombia).
• Confirm in Colombia whether the console is equipo biomédico de tecnología controlada, which takes a permiso de comercialización.
• Map every manufacturing site for console and disposables to a GMP certificate (CBPF in Brazil; CCAA/BPM evidence in Colombia).
• Name the importer(s) who will handle resupply, and make sure they are on the registration before the first disposable shipment.
• Plan future disposables as additions to the same registration (Brazil Art. 2 §11; Colombia modification), not as new files.

What about Mexico and Argentina?

Sponsors usually ask about all four markets together. COFEPRIS and ANMAT have their own grouping rules, and the answer is not always the same. We map them country by country rather than assume one system rule fits all.

Bottom line

A capital device and its exclusive disposables can be registered as one system in Brazil (RDC 751/2022 Art. 3 and Art. 4, XL) and under one registro sanitario in Colombia (Decreto 4725 de 2005 Art. 28). The disposables can then be imported and sold on their own, but only the references the registration actually lists, with labels carrying the registration number, and through an importer that is on the registration. Each component is still classified on its own terms, and every plant that makes a component needs GMP coverage before the agency will sign off.

Planning a console-plus-consumables launch in Latin America? Our Brazil ANVISA registration page, the Colombia INVIMA page and the regional bioaccess® market access hub explain how we hold registrations independently of the distributor, so your disposables revenue isn’t tied to whoever sells the console. Our two-part rate card shows how system and family grouping is priced.

Sources: ANVISA Resolução RDC nº 751, de 15 de setembro de 2022 (Art. 2 §§9–11, Art. 3, Art. 4 I, XXVI and XL, Art. 8 §§1–2, Art. 24), Diário Oficial da União; Decreto 4725 de 2005 (Arts. 2, 7, 20, 25, 28 and 29), INVIMA normograma. This article is general regulatory information, not legal advice. Confirm grouping with the agency’s current rules before filing.