Colombia: Medical Device Reporting Requirements

Good day everyone, and welcome back to another week of MedTech Compliance Chronicles! As we continue exploring Colombia’s regulatory landscape, this week’s post focuses on an essential but often complex aspect of compliance: reportability requirements for medical devices and in vitro diagnostics (IVDs). Unlike in other areas of regulation where distinctions between medical devices and IVDs may exist, reporting obligations in Colombia apply uniformly to both categories.

Regulatory authorities worldwide require manufacturers to report certain events and product changes to ensure patient safety and maintain regulatory oversight. In Colombia, INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) enforces strict reporting obligations, particularly in cases involving adverse events and recalls. Both categories require timely and accurate reporting to prevent regulatory action and ensure continued compliance with market authorization. A failure to report serious incidents can result in fines, product seizures, or even loss of market authorization, making it critical for manufacturers, distributors, and importers to fully understand their obligations.

This post will cover the requirements for adverse event reporting and post-market surveillance, as well as the process for reporting changes to registered devices. Compliance with these requirements is essential to ensuring medical devices in Colombia remain safe, effective, and legally marketed.

Reporting Requirements

Colombia's post-market surveillance framework mandates that all entities involved in the manufacture, distribution, and use of medical products report any adverse incidents, defective or fraudulent products, or labeling deficiencies that could pose health risks. Specifically, any device malfunction, changes in product performance, or deficiencies in labeling or instructions that have caused or could cause death or serious health deterioration must be reported immediately. Reports should be submitted to the Regional Health Offices where the incident occurred, with a copy sent to INVIMA for national oversight.

One requirement somewhat unique to Colombia is the obligation to report instances of misuse, maintenance deficiencies, or other external factors that may compromise the safety or functionality of medical devices and biomedical equipment. While specific reporting timelines for manufacturers and distributors are not explicitly defined, best practice dictates that incidents be reported as soon as they are identified. Colombian health authorities, however, are given a strict two-day window to report incidents they become aware of, meaning that if an issue reaches a regional authority before being reported by the manufacturer, it could raise red flags with INVIMA. To maintain compliance and avoid scrutiny, it is always preferable for manufacturers or distributors to report incidents proactively.

In addition to adverse event reporting, any systematic market withdrawal of similar products due to technical or health-related concerns must also be reported to INVIMA. This includes recalls, market alerts, and safety warnings, all of which play a crucial role in mitigating potential risks associated with defective or hazardous products. Companies must ensure that all corrective and preventive actions related to product safety are documented and communicated promptly to regulators.

Changes

Similar to the U.S. FDA, Colombia requires that significant changes—those that affect the safety, efficacy, or performance of a device—undergo a new health registration process, essentially requiring the device to go through full regulatory review again. These significant modifications can include changes to the device’s design, materials, intended use, or technological specifications.

For non-significant changes, where there is no impact on safety or performance, manufacturers must submit a notification to INVIMA at least 30 days prior to marketing the modified device. INVIMA will review the request and issue an approval or denial within that 30-day window. This reporting requirement extends to any modifications to information contained in the original market authorization, including changes to the brand name, manufacturer’s name or address, or other administrative details.

However, Colombian regulations do not explicitly require manufacturers to report changes to manufacturing processes or their quality management system. While many regulatory authorities around the world mandate reporting of process-related modifications, INVIMA’s requirements focus primarily on product-related changes that could impact safety, performance, or traceability. Despite this, manufacturers should carefully evaluate any changes to determine whether they might indirectly affect safety or efficacy, and when in doubt, consult regulatory experts or INVIMA to avoid compliance risks.

Conclusion

Compliance with Colombia’s reporting requirements for adverse events and product changes is essential for maintaining market authorization and ensuring public health safety. Whether reporting a device malfunction, initiating a recall, or submitting modifications to an approved product, manufacturers and distributors must take a proactive approach to regulatory compliance. Timely reporting not only reduces the risk of enforcement actions but also strengthens a company’s credibility with regulators and the healthcare community.

Understanding when and how to report is key to staying compliant with INVIMA’s expectations. By ensuring that adverse events are promptly addressed, recalls are properly communicated, and regulatory filings for changes are submitted within the required timeframe, manufacturers can maintain seamless market access in Colombia. As always, a well-documented and transparent approach to regulatory reporting is the best strategy for long-term compliance success.