INVIMA safety alerts: what companies should review when a medical device enters follow-up

On May 29, 2026, INVIMA's safety alerts portal published new alerts and safety reports related to medical devices and other technologies. The products listed include medical software, defibrillators, cardiovascular X-ray systems, surgical C-arm systems, CO2 lasers, tracheostomy tubes, resection sheaths and oxygen therapy accessories.

For a company importing, distributing or marketing medical devices in Colombia, a safety alert is not just a technical news item. It is an operational signal that should connect the dossier, the sanitary registration, traceability of marketed units, complaint handling and the technovigilance program.

What follow-up status means

On INVIMA's portal, several publications appear with the status "seguimiento" or follow-up. This means the authority is keeping surveillance over the case and that market participants should assess whether any product, model, reference, batch, software version, accessory or technical configuration under their responsibility may be related to the alert or safety report.

The first review should not rely only on the trade name. In medical devices, the same product family may include accessories, components, software versions, configurations or references that do not always match the name used in an alert. The assessment should therefore start from the full sanitary registration file and the technical-regulatory dossier.

Companies that should activate an internal review

These publications are relevant for:

• Holders of medical device sanitary registrations in Colombia.
• Importers that market devices, accessories or biomedical equipment.
• Distributors with traceability over batches, serial numbers or installed software versions.
• Healthcare institutions operating equipment or technologies under maintenance agreements.
• International manufacturers with a local representative or importer.

The central question is not only whether the product name appears literally in the alert. The regulatory question is whether there is a reasonable link between the technology published by INVIMA and the portfolio authorized, imported, installed or maintained by the company in Colombia.

How the evaluation should be documented

A robust response to a safety alert requires evidence. In practice, the quality system should allow the company to reconstruct:

• The search performed on INVIMA's safety alerts portal and the review date.
• The comparison between the alert and the products registered or marketed by the company.
• The verification of models, references, batches, serial numbers, accessories and software versions.
• The consultation with the manufacturer or international supplier, when applicable.
• The technical decision: affected product, non-affected product or case pending confirmation.
• The defined actions: customer communication, quarantine, withdrawal, software update, maintenance, report or follow-up.

This documentation is especially important when the conclusion is "not applicable." During an inspection, renewal or internal audit, it is not enough to state that the alert was reviewed; the company should be able to show how it reached that conclusion.

Link with technovigilance and registration lifecycle

Resolution 4816 of 2008 structures Colombia's National Technovigilance Program and sets obligations for reporting and managing adverse events or incidents associated with medical devices. The medical device sanitary registration regime also requires the product to maintain safety, quality and performance conditions throughout its lifecycle in the market.

For that reason, an alert published by INVIMA should be integrated into the post-market surveillance system. It should not remain an isolated review by regulatory affairs or an informal communication from the manufacturer. It should connect with complaints, claims, maintenance, traceability, technical direction and document control.

Risks of an incomplete response

When a company does not have a defined process for reviewing safety alerts, risks usually appear in sequence:

• The alert is identified late or not identified at all.
• The commercial team does not know whether units were installed or delivered.
• The technical team lacks sufficient traceability by serial number, batch or version.
• The international manufacturer does not receive a formal confirmation request.
• The company does not retain evidence of the evaluation.
• Technical direction lacks support to decide whether to report, withdraw, correct or communicate.

These gaps do not always lead to an immediate sanction, but they weaken the company's position during an inspection visit, renewal, ex officio review or investigation associated with adverse events.

What to review this week

In light of the alerts and safety reports published on May 29, 2026, a company with a medical device portfolio should review at least four areas:

1. Portfolio map: confirm whether any sanitary registration, permit, accessory, installed equipment or software version is related to the products published.
2. Traceability: verify whether there are units imported, distributed, installed, maintained or held in inventory.
3. Technical communication: request a documented position from the manufacturer or international supplier when there is reasonable doubt.
4. Closure evidence: archive the assessment, decision and actions in the quality system or corresponding regulatory file.

If the assessment confirms that the company is affected, the next step should not be improvised. The response must be aligned with the technovigilance program, the obligations of the registration holder or importer, and INVIMA's specific instructions for each case.

A safety alert also tests system maturity

Safety alerts do not only test product safety. They also test the maturity of the company's regulatory system: whether the portfolio is organized, whether the dossier allows references to be compared, whether traceability reaches the customer, whether technical direction can make evidence-based decisions and whether the technovigilance program operates continuously.

Vexpro supports medical device companies in structuring and auditing post-market surveillance systems, regulatory traceability and lifecycle management before INVIMA. When an alert may affect your portfolio, an early and documented review reduces uncertainty and improves response capability.

Sources consulted

• INVIMA, safety alerts portal for medical devices and other technologies, publications dated May 29, 2026. Accessed June 1, 2026: https://app.invima.gov.co/alertas/dispositivos-medicos-invima
• INVIMA, sector information on medical devices and biomedical equipment. Accessed June 1, 2026: https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/dispositivos-medicos-equipos-biomedicos