Medical Devices in Colombia: Classification, Risk and Registration with INVIMA

A medical device is any instrument, apparatus, machine, software or similar article intended for the prevention, diagnosis, treatment or relief of a disease or injury in human beings. In Colombia, medical devices are regulated by INVIMA, which classifies them into four classes according to their risk level (I, IIA, IIB, III) and requires a sanitary registration for them to be marketed.

What is a medical device?

A medical device achieves its main effect by physical or mechanical means, not by pharmacological, immunological or metabolic action. That is the central difference from a drug: a drug acts on the body by a chemical route, a device does not. That is why the two are regulated through different paths with INVIMA.

Software can also be a medical device. INVIMA classifies it that way when its intended purpose, as set by the manufacturer, is to diagnose, prevent, monitor, treat or relieve a disease, or when it interacts with biomedical equipment and controls it. A program that only manages appointments or medical records is not a medical device; one that interprets an image to support a diagnosis can be.

What are the types and examples of medical devices?

The category is very broad. A practical way to understand it is by the function the device performs:

• Diagnosis: thermometers, blood pressure monitors, glucometers, imaging equipment.
• Treatment: scalpels, sutures, dialysis equipment, infusion pumps.
• Life support: ventilators, pacemakers, defibrillators.
• Rehabilitation and support: prostheses, orthoses, wheelchairs.

The same type of product can fall into different risk classes depending on its intended use and its level of invasiveness. That is why classification depends on what the device does and the risk it entails, not on its brand name.

Risk classification: class I, IIA, IIB, III

Decreto 4725 de 2005 (Decree 4725 of 2005) classifies medical devices into four classes according to their risk level. The higher the risk, the stricter the health control INVIMA applies.

Class	Risk level	Health control	Examples
Class I	Low	General controls	Gauze, stretchers
Class IIA	Moderate	Special controls	Catheters, suction equipment
Class IIB	High	Reinforced special controls	Blood bags, ventilators
Class III	Very high	Rigorous control regime	Implants, pacemakers

The class determines the rigor of the procedure, but not the validity: a medical device’s sanitary registration lasts 10 years for all classes (Decreto 4725 de 2005). Misclassifying a device is one of the most common and costly mistakes, because it can delay the procedure by months or lead to its rejection.

Controlled-technology biomedical equipment

Controlled-technology biomedical equipment consists of medical devices subject to special health control because of their risk level and their technology. Unlike other medical devices, they do not require a sanitary registration, but a marketing permit. That permit authorizes a natural or legal person to produce, market, import, export, assemble, process, dispense or sell the controlled biomedical equipment.

You can read more on the difference between INVIMA’s types of authorization in our article on what INVIMA is and the health authorizations it issues.

How are medical devices registered with INVIMA?

A medical device’s sanitary registration is processed with INVIMA through the Oficina Virtual, INVIMA’s online portal (app.invima.gov.co), and is valid for 10 years for all classes. The requirements and the level of assessment depend on the device’s risk class: a class I is approved with general controls, while a class III goes through a much more rigorous regime. Renewal of the registration must be requested at least 3 months before expiration.

For the detail of the procedure, the required documents, the platforms and the timelines, see our complete guide to INVIMA sanitary registration. There we explain the process step by step for the products that require a sanitary registration.

In vitro diagnostic reagents

In vitro diagnostic reagents are a category of their own, distinct from medical devices, although INVIMA also regulates them. They are products used to analyze samples of human origin outside the body, for diagnostic purposes. They are classified into three categories (I, II, III) and require a sanitary registration. If your product is a diagnostic reagent, the regulatory path is different from that of a medical device.

How SPI Américas supports you with medical devices

Correct classification is the starting point of every medical device procedure. Based on the experience of SPI Américas’ regulatory team, it is the step where companies go wrong most often. The regulatory affairs team at SPI Américas supports manufacturers and importers in defining the risk class, preparing the sanitary registration or the marketing permit as applicable, and renewing current authorizations. If you are going to launch, import or renew a medical device in Colombia, write to us at [email protected].

Official sources cited

Decreto 4725 de 2005 (classification and registration of medical devices), invima.gov.co, normograma.invima.gov.co.