INVIMA Colombia Labeling, IFU & Traceability

Colombia medical device label requirements

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.

Label and semantic-record release checks

An additional label must not obscure required original information or introduce unsupported claims. Confirm the actual labeling provision before treating every technical mark as prohibited from overlap. Use the INVIMA semantic-standard entry for current scope and platform instructions, and link changes to registration maintenance.