Currently, Colombia is undergoing a pivotal moment in its public health. It is not an exaggeration to say that the system, as we know it, is under pressure. The crisis of the Health Promoting Entities (EPS) has been brewing for years. Still, in recent months, it has intensified, leading regulatory authorities to become much stricter in ensuring the quality of products associated with the health sector, such as medical devices. Added to this are public health emergencies that necessitate more stringent controls throughout the supply chain, from the importation of a medical device to the inspection of a production plant. It is not only a matter of complying with regulations out of obligation. Today, more than ever, national control systems are focusing their attention on traceability, inspections, and quality audits in the health sector. And, of course, INVIMA, as the primary regulatory entity, is responsible for this task. Suppose your organization manufactures, imports, or distributes health-related products in Colombia. In that case, you have surely noticed that now technical visits are more frequent, documentation requirements are stricter, and, of course, sanctions are faster when non-compliance is detected. For manufacturers, importers, and distributors, this means operating in an environment where quality is non-negotiable and where transparency at every step of the chain has become a key factor in maintaining market trust and, above all, protecting consumer health. Health System Crisis That Compromises Quality Assurance When discussing regulation in public health in Colombia, we must refer to the aforementioned crisis of the Health Promoting Entities (EPS). A prolonged financial deficit, payment delays, and recurrent administrative failures have left consequences throughout the supply chain. And when the system’s resources are low, the quality of the products and services offered to the market is at risk. The Government, faced with an issue affecting the population, has responded by tightening surveillance and safety measures, making it clear that it is not only about “punishing” non-compliance but also about preventing it. This implies more frequent inspections, unannounced audits, and stricter supervision of traceability. INVIMA and Its Role in Quality Assurance for Medical Devices in Colombia In day-to-day practice, INVIMA is the authority that makes the most visible decisions in this area. Its role is not new, but it has become more prominent. It oversees everything from the sanitary registry to the verification of Good Manufacturing Practices (GMP) in production plants, including audits that can extend across the entire logistics chain. Currently, INVIMA is progressively updating the regulations that govern medical devices and other healthcare technologies in Colombia, aiming to enhance evaluation, certification, and quality control processes for these products within the country. Among the measures implemented is the updating of requirement manuals for medical device manufacturers and importers. Additionally, the strengthening of sanitary surveillance in accordance with international safety standards is being implemented to ensure that products meet the established guidelines. Regarding medical devices, INVIMA’s supervision covers: Reviewing technical documentation before approving a sanitary registry. Inspecting production processes to ensure that manufacturers comply with Good Manufacturing Practices (GMP). Validating the existence of a traceability system to monitor each production batch. And this is where many companies discover that it is not enough to “do things right.” They must be able to prove it. Regulations and Quality Control of Medical Devices in Colombia INVIMA prioritizes the regulation of medical devices in its comprehensive regulatory framework. And for good reason: a defect in their design or manufacture can have direct consequences on patients’ lives. Consequently, the integration of international standards and national requirements is of paramount significance. Among them, ISO 13485 stands out as a global standard. Its main objective is to ensure that manufacturers meet regulatory and market requirements. It provides a framework for implementing a quality system. This includes establishing processes that guarantee safety and quality throughout the product’s lifecycle. The design, development, production, distribution, installation, and maintenance of products must be carefully considered. For a company that wants to market medical devices in Colombia and concurrently export to other markets, complying with ISO 13485 is not optional: it is a key that opens doors and prevents sanctions. Importation and Traceability in Medical Devices Quality Control In the medical device industry, each country has its own set of controls, and in Colombia, that set is particularly stringent. The process begins long before the goods arrive at the port, starting at the plant in the country of origin, where documents, certificates, and tests are prepared to support every detail of the product. If any of these elements are not in order, the journey stops before it begins. One of the first filters is documentation. It is not enough to have a valid sanitary registry; the file must support, with technical evidence, that the device complies with national standards. On more than one occasion, a simple discrepancy between the product’s serial number and the one that appears on the certificate has been enough to delay a shipment for weeks. The next point of attention is labeling. Colombian regulation establishes very specific parameters: from the language and legibility of the information to the order in which critical data, such as the quantity, expiration date, and storage conditions, must be presented. Additionally, the language and legibility of the information must be considered. Even a minor error in printing may lead to the entire quantity being withheld. Traceability, in turn, serves as the foundation of control. Each medical device can be monitored through a well-organized management system, which includes its manufacturing location, dispatch date, routes, and healthcare entity. This capability is not only a legal requirement; it is a protection mechanism for the organization and, ultimately, for the consumer. When a product is recalled, having this information immediately can make the difference between solving an issue swiftly or facing a problem involving authorities and institutional clients. Organizations that have invested in integrated traceability platforms, capable of connecting real-time data from the supplier to the end user, have found that the benefit goes beyond compliance. They gain trust with INVIMA, reduce response times, and position themselves better in a market where there is less and less room for error. Regulatory Changes for Medical Device Registration in Colombia In the face of stricter controls, changes and transformations are creating new opportunities. Recently, INVIMA has been moving towards faster approval of medical devices. Not long ago, the agency began using digital tools that better organize information and allow products to be tracked even after they are on the market. This is important because when it comes to investigating a defect or responding to a health alert, having clear and accessible data makes the difference. Specifically, INVIMA has made progress in monitoring and regulating medical devices and in vitro diagnostic reagents by implementing the reporting platform of the semantic standard and coding of medical devices and reagents, in compliance with Resolution 1405 of 2022. The semantic standard is a tool that enables the uniform naming of medical devices and in vitro diagnostic reagents, allowing manufacturers and importers to more effectively manage the consumption of medical devices in Colombia and facilitating surveillance agencies in identifying products within supply chains. Today, with this tool, a manufacturer can obtain a sanitary registry in an average of two months, and an importer in just over two and a half months. Not always, of course; if the documentation is incomplete or there are technical doubts, the process may take longer. But for those who prepare their file well, the reduction in time is evident. For companies, this has a double meaning. On the one hand, the requirement to comply with standards such as ISO 13485 remains intact: clear processes, traceability, and up-to-date documentation. On the other hand, if everything is in order from the beginning, the procedure can be resolved faster and with fewer setbacks. In such a competitive market, this combination of compliance and agility is no small detail. It can be the difference between bringing an innovation to market on time and missing the opportunity. In the end, more than a benefit, it is an invitation for the industry to be better prepared, because the door to faster registration is open, but only for those ready to cross it. Conclusion The strengthening of the regulatory framework in Colombia is a trend that will continue in response to real problems faced by the health sector. For organizations, this means that quality and compliance are moving from being a differentiating factor to becoming a minimum condition for competing. Adopting the international ISO 13485 standard and complying with INVIMA’s requirements is crucial to compete in the market and remain sustainable over time. Quality, traceability, and transparency are indispensable for the commercialization of medical devices in Colombia. Organizations that can ensure compliance through an efficient quality management system supported by international certifications will not only avoid sanctions but will position themselves as trustworthy companies before regulators and consumers alike. While INVIMA advances in technological developments that promise process optimization, such as the registration of medical devices, organizations must embrace these solutions and be willing to implement changes that lead to improvements in their internal processes. About Pro QC In a sector marked by high regulatory demands, having a strategic partner with proven experience becomes a competitive advantage. Pro QC International is recognized for supporting manufacturers and distributors of medical devices in Colombia and worldwide. With more than 40 years of experience in quality control and assurance, Pro QC has enhanced its contribution to the health sector thanks to a portfolio of services specially designed for medical devices: Supplier and factory audits tailored to key standards such as ISO 13485, ISO 11137, ISO 15189, ISO 15378, and GMP 21 QSR 820, as well as quality systems (ISO 9001) and environmental management (ISO 14001). Product quality inspections: First Article Inspection (FAI), In-Process Inspection, Pre-Shipment Inspection (PSI), and Container Loading Supervision (CLS). Supplier management: manufacturing process audits, production capacity analysis, process optimization, among others. Pro QC’s global presence, with coverage in more than 100 countries, allows it to act quickly wherever clients need it. This flexible and specialized network is trained to provide inspections, audits, and support in multiple countries, including quality control services in Colombia. Pro QC offers strategic support to strengthen the credibility of medical device companies in an increasingly rigorous regulatory environment. Contact us.
