Health registrations in Colombia: evolution, challenges and new developments in the regulatory system

registro sanitario en colombia

In Colombia, health registrations play an essential role in ensuring that products reaching consumers meet minimum standards of safety, quality, and efficacy. Although the term "health registration" is often associated with food or medicine, it actually encompasses a much broader range: cosmetics, dietary supplements, medical devices, household pesticides, and a large portion of products subject to health controls.

Over the past few years, the Colombian regulatory model has undergone adjustments marked by technological advancements, regulatory reforms, and institutional transformations at INVIMA, the authority responsible for its administration. This article presents a comprehensive overview of the system, its operation, its challenges, and the most recent developments announced by the institution.

1. What is a health registration in Colombia and why is it essential?

A health registration is the state authorization to market a product subject to health oversight. It is the permit that certifies that a product meets the established technical requirements to ensure that its use does not pose risks to public health.

In Colombia, this process is based on principles such as health protection, risk prevention, traceability, transparency, and regulatory harmonization with international standards. For companies, it also provides legal support and clear guidance for formulating, producing, importing, or distributing regulated goods.

2. Regulatory framework: a dynamic and robust system

Colombian regulations combine general rules with specific regulations for each product category. Among its cornerstones are Law 9 of 1979, Law 100 of 1993, provisions such as Resolution 2674 of 2013 for food and beverages, Decree 677 of 1995 for medicines, and the Andean decisions that harmonize criteria at the regional level.

The framework is complemented by updated regulations for cosmetics, medical devices, dietary supplements, and other categories that require alignment with standards from organizations such as the WHO, FAO, and PAHO. This dynamic approach makes the Colombian system one of the most comprehensive in the region.

3. The general process of obtaining a health registration

Although each category has particular requirements, the process usually includes several stages that act as filters to ensure product safety.

The first is the presentation of technical information, which normally includes the composition, specifications, safety evidence and documents that prove compliance with quality standards.

The second is the evaluation by INVIMA, where a technical team analyzes the product's compliance with current regulations.

The third stage is the decision, which may result in authorization, a request for additional information, or denial.

Finally, companies must fulfill subsequent obligations, such as maintaining initial conditions, updating relevant changes, and complying with monitoring regulations.

4. The role of INVIMA: modernization and institutional strengthening

The National Institute for Drug and Food Surveillance is the authority that manages the health registration system and ensures compliance with regulations.

One of the most significant advances has been the digitization of procedures. The gradual migration to electronic platforms has improved traceability, reduced processing times, and standardized documentation.

INVIMA has also modernized technical guides and guidelines, updating criteria in food, dietary supplements, cosmetics, medical devices and other categories, in order to maintain equivalence with international standards.

At the institutional level, the entity has announced reorganization plans aimed at optimizing processes, strengthening technical capabilities and improving service to system users.

5. Recent news from INVIMA

In recent years, INVIMA has reported significant progress and adjustments. One of these is the operational reorganization, which has included the redistribution of technical staff and the optimization of specialized areas to improve efficiency.

The agency has also strengthened interoperability with other institutions such as the Ministry of Health, the ICA (Colombian Agricultural Institute), the DIAN (National Tax and Customs Directorate), and various territorial authorities. This effort aims to improve product traceability, facilitate regulatory monitoring, and harmonize criteria across sectors.

Another important development is the updating of technical guidelines on topics such as nutritional labeling, good manufacturing practices, standards for dietary supplements, and evaluation criteria for imported products. These updates reflect scientific advancements and the need to maintain equivalence with global standards.

Finally, the institution has invested in modernizing its analytical infrastructure, strengthening laboratories and adopting more robust techniques to improve analysis and surveillance capacity.

6. Impact of the health registration system on the business sector

For companies, health registration is much more than a legal requirement. It allows them to innovate with technical support, access global markets, and build consumer trust.

The system helps reduce legal risks, professionalize production, and ensure that products meet international quality standards. In sectors with high export potential, such as food, cosmetics, supplements, and natural products, regulatory compliance becomes a competitive advantage.

7. Challenges of the Colombian health registration system

Despite its progress, the system faces significant challenges . One of these is the need for constant updating in the face of innovations in functional foods, emerging ingredients, biotechnology, digital medical devices, and plant-derived products or new ingredients.

Another crucial challenge is the complete technological modernization of document processing and management systems. Although progress has been made, further standardization and training are still needed.

Operational capacity is also a challenge, given the increased demand for procedures and the technical complexity of innovative products.

Finally, ongoing international alignment requires permanent adjustments to maintain equivalence with organizations such as the WHO, FAO and benchmark regulatory agencies in Europe, North America and Asia.

8. Global trends that will influence the Colombian system

International health regulations are moving towards risk-based surveillance models, digital traceability, and the use of artificial intelligence in health management. There is also an increase in e-commerce of regulated products, a greater diversity of innovative ingredients, and the development of new categories such as functional foods and plant-based products.

Colombia will have to adapt to these trends to maintain the competitiveness of the productive sector and strengthen its surveillance system.

9. Conclusion

The Colombian health registration system is one of the most comprehensive and dynamic in the region. It combines a robust regulatory framework, a technical authority with a proven track record, and a constantly modernizing process.

Recent developments at INVIMA demonstrate a commitment to digitalization, regulatory updates, institutional interoperability, and strengthening technical capacity. For companies, this environment represents an opportunity to improve quality, innovate, and expand into international markets.

Colombia is at a key moment to consolidate a more agile, updated system aligned with global best practices, capable of responding to the challenges of modern industry and effectively protecting public health.