Government issues new health regime for medical devices in Colombia

The Ministry of Health prepares a draft decree with which it comprehensively updates the sanitary regime applicable to medical devices for human use in Colombia.

The document, found in comment phaseis described as a long-awaited reform that seeks strengthen patient safetymodernize health surveillance and harmonize national regulation with international standards.

The standard, issued by the Ministry of Health, redefines the rules for the marketing authorizationthe control and surveillance of medical devices throughout their life cycle, from design and manufacturing to their use, monitoring, post-marketing and final disposal. With this measure, the Executive replaces a regulatory framework considered outdated in the face of technological advances of the sector.

More news:A low increase in the UPC would generate a million-dollar deficit in the contributory regime

A modern framework aligned with global standards

One of the central axes of the new decree is the adopting a risk-based approach. Based on this logic, the marketing authorization of medical devices is classified into three categories: health notification for low and moderate risk products, health record for those at high and very high risk, and marketing permit for technologies considered special control.

The Government explained that this differentiation would allow a more efficient supervision by the National Institute for Food and Drug Surveillance (INVIMA), concentrating greater regulatory efforts on those devices that represent a highest risk to public health.

In addition, the draft decree incorporates definitions and concepts aligned with the International Medical Device Regulators Forum (IMDRF)an organization to which Colombia was accepted as an affiliate member in 2025.

“This step marks progress in international regulatory convergence and facilitates the recognition of evaluations carried out by leading foreign health authorities,” the document states.

In Vitro Reagents and medical software, within the scope

The decree expressly extends the scope of the health regime to those In Vitro diagnostic reagentsrecognizing them as medical devices, in accordance with international standards.

“Also includes so-called software as a medical device (SaMD)”, an increasingly relevant category in contemporary clinical practice.

According to the Ministry of Health, this inclusion responds to the need to close regulatory loopholes facing digital technologies used for diagnosis, monitoring and support of clinical decisions, guaranteeing criteria of safety, performance and effectiveness.

Essential Safety and Performance Principles

The new regulation establishes mandatory essential principles of safety and performance that all medical devices must comply with.

“Among them are the obligation of manufacturers to implement quality management and risk management systems, as well as demonstrate that the benefits of the device outweigh the risks associated with its use,” indicated the Ministry.

These principles must be applied throughout the life cycle of the product and will be evaluated by the health authority as part of the authorization and surveillance processes. The approach seeks to move from a purely documentary control to one based on evidence and clinical performance.

You may be interested in:Closure of Colsubsidio dispensaries generates uncertainty among Nueva EPS members

Surveillance, post-marketing and traceability

Another key aspect of the decree is the strengthening health surveillance, post-marketing.

“Manufacturers and authorization holders must have comprehensive monitoring systems that allow incidents, adverse events and risk trends to be reported,” the Ministry stressed.

The standard also reinforces the mechanisms of traceabilityfacilitating the identification of batches, series and implantable devices, a key element for the management of health alerts and the patient protection.

Impact for the health sector and industry

The Ministry of Health indicated that the update of the health regime seeks to balance two objectives: protect public health and promote a competitive and transparent market.

For manufacturers, importers, distributors and institutions providing health services, the new draft implies greater technical and documentary responsibilitiesbut also clearer rules in line with the technological reality of the sector.

A key step for medical device policy

The issuance of this decree is part of the National Medical Device Policy adopted in 2024 and responds to the findings of the Regulatory Impact Analysis carried out by the Government, which showed shortcomings in the current regulation.

Points in favor of the draft decree

1. Update an obsolete regulatory framework: Replaces regulations that are more than 15 years old and strengthens regulatory coherence.

2. Risk-based approach: It allows for more efficient and proportional surveillance, improving patient protection.

3. Harmonization with international standards: It facilitates the recognition of foreign evaluations and drives innovation.

4. Strengthens post-marketing surveillance: Improves early risk detection and health alert management.

5. Includes emerging technologies: Closes regulatory gaps regarding the digitalization of the health sector.

6. Alignment with the fundamental right to health: Prioritize access to safe and quality technologies.

Points against

1. Greater regulatory burden for the industry: It could increase operating costs, especially for SMEs.

2. Risk of congestion in INVIMA: More checks could lead to delays if capacity is not strengthened.

3. Complex implementation for IPS and laboratories: It could make adaptation difficult in regions with lower capacity.

4. Ambiguity in some technical concepts: It could lead to different regulatory interpretations.

5. Possible impact on access times: The increased requirements could delay the arrival of some devices.

6. Demanding regulatory transition: It involves adaptation processes that can generate uncertainty in the short term.