INVIMA Colombia Medical Device Labeling
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Medical devices imported to Colombia can use existing labeling with some modifications.
Colombia medical device label requirments
Medical devices imported to Colombia can use the same labeling as in the country and language of origin with some modifications. Manufacturers can affix an additional label in Spanish that includes the name of the device, the name and address of the manufacturer, the name and address of the importer, and the sanitary registration issued by INVIMA. The additional label cannot obscure any portion of the original label.
At minimum, medical device labels should convey:
- The Lot number;
- The Expiration date, if applicable;
- Special legends, such as sterile, single-use, etc.
Information required for Colombia medical device labels
Like most markets, medical devices sold in Colombia must communicate the minimum information necessary to use the device safely. However, some information can be provided on an additional label or insert, for example:
- Intended use;
- Package contents;
- Storage conditions;
- Specific warnings or precautions;
- Necessary information to correctly install the device so it functions correctly and safely, as well as other treatment necessary before use (e.g., sterilization, final assembly, calibration, etc.);
- Details on the nature and frequency of preventive maintenance;
- The details of any other treatment or management necessary before the device can be used;
- Indication if the device is provided sterile and, if possible, methods for re-sterilization;
- Indication if the device is reusable or single use, and processes to allow re-use, including cleaning, disinfecting, and packaging;
- If the device is implantable, information concerning any risks specifically related to its implantation.
Information that does not apply to your device does not need to be included in the labeling.
Advertising Medical Devices in Colombia
In Colombia, any claims you make about your device in advertising or marketing must be supported by scientific evidence and cannot exaggerate the benefits to the user or patient. In addition, you cannot advertise your device in a way that defames or damages another brand, product, or organization. The Legal Representative can be held liable for the impact of medical device claims in advertising to patients or public health.
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Pure Global replaces fragmented regulatory consulting fees with a single annual cost that covers registration, representation, and ongoing compliance. From faster, AI-enabled dossier preparation to post-market surveillance, everything required to keep your device compliant in Colombia is included. No hourly billing or unexpected invoices.
Frequently asked questions
Plan for a compliant physical label and do not assume that electronic labeling alone will satisfy INVIMA. Digital content may supplement approved information in some circumstances, but the applicable device rules, registration terms, and current INVIMA position should be confirmed before implementation.
In general, Class I medical devices can be advertised in mass media. Class IIa, IIb, and III medical devices and biomedical equipment that are intended for exclusive use by health professionals or must be prescribed can only be advertised or promoted in scientific or technical publications.
Only IVDs with valid health registrations can be advertised in Colombia. Any claims or benefits advertised must be congruent with the claims and indications approved by INVIMA according to the product’s health registration.
Colombia’s Resolution 1405 of 2022 requires all sanitary registration holders for medical devices and IVDs to implement Unique Device Identifier – Device Identifier (UDI-DI) codes for product identification and traceability. These codes must be sourced from recognized international agencies such as GS1, HIBCC, ICCBBA, IFA, Ali Health, or ZIIOT. Registration holders must submit a semantic report through INVIMA’s web platform, detailing the device’s basic, regulatory, and commercial attributes. The process involves obtaining UDI-DI codes, securing INVIMA approval, and paying a fee to complete the submission. Compliance is already mandatory for most devices, with a deadline of February 8, 2026, for Class IIa, Class I, and Category I IVDs.
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