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Invima set AI rules for its own staff and built in a clause that pushes them onto counterparties by contract
Correction, October 1, 2026. This article restores an accent in the Spanish quotation, corrects the reference-list count, removes an unsupported first-policy claim and clarifies that contractual duties depend on the instrument and parties involved. The original publication date is unchanged.
Colombia's food and drug regulator wrote an artificial intelligence policy for its own desks. It also specifies when those guidelines apply to counterparties through their contracts.
Bottom line: Binding, and already signed. Numeral 2 makes the guidelines of mandatory compliance for Invima dependencies, public servants, contractors and other collaborators. For third parties holding any legal relationship or link with the Institute and having access to its information systems, technology resources or digital assets, the text says the guidelines are exigible only to the extent they have been incorporated through clauses, obligations, annexes or express provisions of the relevant contract, agreement or legal instrument. No transition period and no compliance deadline appear anywhere in the document.
Who this affects: Regulatory affairs and quality officers at pharmaceutical and medical device sponsors that hold or seek Colombian sanitary registrations, the local regulatory agents and consultancies that file on their behalf, Colombian counsel advising on market access, physicians and laboratory staff whose submissions pass through Invima systems, and Invima personnel themselves.
Issue date: Decision date 6 August 2026, the date printed on the circular and on its electronic signature registry. Published in the Diario Oficial of 10 August 2026. The draft was posted for public comment from 23 to 27 July 2026. No deadline is set.
What changed: The circular sets out: a three-tier risk classification for AI systems it acquires, develops or uses, an algorithmic impact assessment that may be run before a high-risk deployment, six categories of prohibited use, separate rules for generative tools, an algorithmic transparency publication duty, and a table assigning responsibilities to named offices including third parties bound by contract.
Analysis: Numeral 2 expressly conditions the guidelines' application to third parties on incorporation in the governing legal instrument. A supplier should check the actual agreement and incorporated obligations; the circular alone does not establish what its contract requires.
Primary sources: Circular Externa 1000-018-2026 (PDF, Invima) · Direct PDF download (Invima library) · Gazetted text record (vLex, Diario Oficial 10 August 2026)
- Instrument (EN)
- External Circular No. 1000-018-2026, Guidelines for the use of artificial intelligence
- Authority
- Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), Direccion General
- Jurisdiction
- Colombia
- Status
- Signed and issued. Ten of ten electronic signatures recorded, signed by the Director General
- Bindingness
- Of mandatory compliance for Invima dependencies, public servants, contractors and other collaborators. Exigible against third parties only to the extent incorporated by clause, obligation, annex or express provision of the governing contract or agreement
- Issue date / next deadline
- 6 August 2026. Gazetted 10 August 2026. No deadline, transition period or effective date is stated in the text
- Signed by
- Francisco A. G. Rossi Buenaventura, Director General
- What it is not
- Not a marketing authorisation pathway, not a medical device classification rule, and not a general-market AI statute
- Primary source
- https://www.invima.gov.co/biblioteca/circular-externa-ndeg-1000-018-2026pdf
Informational analysis for working professionals, not legal advice. Confirm applicable obligations with qualified counsel.
What the circular sets out to do
Numeral 1 states the objective in ordinary administrative language: establish guidelines for the use and application of artificial intelligence that strengthen and drive the activities of the Institute while preserving information security, personal data protection and copyright protection, in its digital and physical environment, through adequate management of use, risks and associated services.
It is issued in the framework of CONPES 4144 of 2025 and Joint Directive 007 of 2025 of the Procuraduria General and the Defensoria del Pueblo. The circular applies that framework to the Institute. Its reference list also cites Circular Invima 1000-009-2026; we have not established whether this is Invima's first AI instruction.
The normative reference list in numeral 3 contains twenty-one bullet entries, from the 1991 Constitution and Law 23 of 1982 on copyright through Law 1581 of 2012 on personal data to Superintendence of Industry and Commerce External Circular 002 of 2024. Invima is not claiming new legal authority here. It is compiling authority it already sits under and applying it to a technology.
The four control areas, checked against the text
Numeral 5 requires the Institute to classify the AI systems it acquires, develops or uses into high, medium and low risk. High risk covers systems that intervene in decisions with significant legal or material effects on people's rights or on sanitary safety, and the text gives examples: systems supporting surveillance and control actions, prioritisation of filings that affects access to products, and processing of sensitive data. Those require reinforced human supervision and periodic review. Before deploying a high-risk system the responsible unit, with the Information Technology Office and the Information Security Officer, may carry out an algorithmic impact assessment. The modal there is podra, not debera. It is a permission, not a mandate, and a reader who reports it as a required assessment has overstated the text.
Information security is present twice. Numeral 4.2 sets availability, confidentiality, integrity and authenticity as principles. Numeral 6 then converts them into use rules, including a duty to adopt administrative and technological security measures over information generated, consulted or applied through AI, and it cross-references numerals VIII and IX of the Superintendence of Industry and Commerce circular.
Personal data is present and specific. Numeral 6 forbids the use of sensitive data absent the data subject's authorisation and reproduces the article 6 and article 5 categories from Law 1581 of 2012, health data, sexual life and biometric data among them. Numeral 10(e) adds that where an algorithmic system involves processing of personal data, the Institute will guarantee compliance with Law 1581 and its implementing rules.
The copyright provisions also address vendor warranties. Numeral 6 requires measures to prevent AI tools from producing outputs that reproduce protected works, verification of content before use, and demanding from the provider the declarations and warranties on the licensing of the tool and of the data used. Numeral 7(f) then prohibits using tools based on protected works without authorisation.
Human decision, social scoring, mass surveillance
Numeral 4.1, under the proportionality and harmlessness principle, states: Las decisiones finales con impacto irreversible o de vida o muerte deben ser tomadas por un ser humano. La IA no debe usarse para calificación social ni para vigilancia masiva. The quotation above restores the accent in calificación found in the official PDF.
The sentence appears in the principles section. The circular also contains specific provisions addressing human responsibility for administrative decisions. Numeral 7(a) prohibits adopting final administrative decisions with legal effects in an automated way without human intervention. Numeral 7(b) prohibits substituting the motivation of an administrative act. Numeral 10(b) requires that any definitive administrative decision with significant legal or material effects be adopted or validated by a competent public servant who assumes responsibility for it.
The social scoring and mass surveillance prohibition likewise appears twice: as a principle in 4.1 and as a flat prohibited use in numeral 7(d), which also bars processing that generates discrimination.
Generative tools get their own numeral. Every output must be reviewed and validated by the responsible servant before use; normative, case law, technical and quantitative references must be verified specifically because the tool may produce inexact or non-existent information, a risk the circular names in quotation marks as alucinaciones; nothing unverified may enter an administrative act, legal opinion, petition response or official communication; and where a generative tool is used in drafting an administrative act, legal opinion or petition response, a record of that use is left in the document.
The mechanism a US sponsor should care about
Read numeral 2 and the Paragrafo to numeral 7 together and the shape becomes clear. Numeral 2 extends the guidelines to third parties with any legal relationship or link to the Institute who have access to its information systems, technology resources or digital assets, and then conditions that extension: the guidelines are exigible in the measure in which they have been incorporated through clauses, obligations, annexes or express provisions of the contract, agreement or legal instrument governing the relationship. The Paragrafo to numeral 7 repeats the condition for the prohibited uses specifically, adding that the restrictions bind linked third parties only when expressly incorporated, without prejudice to legal obligations already applicable to them.
The responsibilities table in numeral 12 says the same thing a third time, in a row headed terceros vinculados mediante contrato o convenio: comply with the AI, data protection, confidentiality, information security and intellectual property obligations agreed in the instrument signed with the Institute, and attend to the AI controls Invima has incorporated contractually.
So the regulator has drafted a policy it can hand to procurement as ready-made contract text. Nothing forces the clause into any given contract. But once it is in, a US sponsor's Colombian agent is holding an obligation set written by the agency that reviews its filings, enforceable through the contract rather than through sanitary law. We call that an internal directive made contractually exportable. The circular does not use that framing and does not present itself as a supply chain instrument; the reading is ours.
The practical consequence is narrow and checkable. Someone should read the current Invima-facing agreements and any renewal drafts for an AI annex or an incorporation-by-reference clause. If the agreement incorporates these guidelines, identify which obligations it imposes and on whom. The circular does not establish that an agent's obligations automatically become its sponsor's obligations, and the absence of incorporation does not remove independently applicable law.
The scope of this circular
Invima's circular addresses its own processes and personnel and specifies the conditions under which its guidelines apply to third parties. This article does not compare the full requirements of other Colombian AI instruments.
The SIC circular appears in the normative references, and numeral 6 expressly cross-references its information-security provisions. The legal effect of those cross-references requires reading the relevant instruments together.
The circular does not set out an approval, classification or registration pathway for AI-enabled products. It says nothing about software as a medical device. A sponsor looking for a Colombian AI device pathway will not find it here.
What we did not verify
We opened and read the full Spanish text of Circular Externa 1000-018-2026 from Invima's own library, extracted through a PDF parser, covering numerals 1 through 14, the responsibilities table, the signature block and the electronic signature registry. We separately opened the gazetted record at vLex, which states a publication date of 10 August 2026 and a decision date of 6 August 2026, and read the portion of the gazetted text available without a subscription, running through numeral 4.1. The quotation was checked against the official PDF; this correction restores its missing accent.
We did not open the Diario Oficial issue of 10 August 2026 directly, so the gazette date rests on the vLex record rather than on the gazette itself. We did not open Invima's normatividad index page and therefore did not independently confirm how the circular is listed there. We did not open CONPES 4144 of 2025, Joint Directive 007 of 2025, Circular Invima 1000-009-2026, Decreto 385 de 2026, or the referenced ethics guide. We did not obtain the technical annex described in numeral 13 and have not established whether it has since been issued. We did not review any actual Invima contract or annex, so we have no evidence about how often the incorporation clause is in fact used.
We refuse to claim that this circular regulates Colombian health companies generally, that its stated extension to covered third parties applies without the incorporation described in numeral 2, that it creates an approval or clearance route for AI products, or that the algorithmic impact assessment is mandatory. We also decline to say how many contracts are affected. We have no denominator for that and did not look for one.
Review the current Invima-facing agreement and any incorporated AI provisions. The circular applies directly to the Institute and its own personnel; its stated third-party extension depends on the governing instrument. Identify the contracting party and the duties actually incorporated before assigning them to a sponsor or agent.
Source File
https://www.invima.gov.co/biblioteca/circular-externa-ndeg-1000-018-2026pdf
Open the Invima PDF and confirm three things: numeral 2 (Alcance) makes the guidelines enforceable against covered third parties to the extent they are incorporated in the governing legal instrument; numeral 4.1 contains the quoted human-decision and social-scoring sentence; and the Paragrafo to numeral 7 repeats the incorporation condition for the prohibited uses. Then open the vLex record to confirm the decision date of 6 August 2026 and the Diario Oficial publication date of 10 August 2026.
Las decisiones finales con impacto irreversible o de vida o muerte deben ser tomadas por un ser humano. La IA no debe usarse para calificación social ni para vigilancia masiva. · Circular Externa 1000-018-2026, Invima, numeral 4.1, 6 August 2026
FAQ
Does this circular regulate every health company operating in Colombia?
No. It is addressed to Invima dependencies, public servants, contractors and other collaborators of the entity, and to third parties holding a legal relationship with the Institute who have access to its information systems, technology resources or digital assets. Even for that third group, numeral 2 says the guidelines are exigible only to the extent they have been incorporated through clauses, obligations, annexes or express provisions of the governing contract or agreement. This condition concerns the stated third-party extension. It does not remove independently applicable duties or the separate mandatory scope for Invima's own contractors and collaborators.
Our Colombian regulatory agent files on our behalf. Are they bound?
For an agent covered as a third party under numeral 2, the stated extension depends on incorporation through a clause, obligation, annex or express provision of the governing instrument. The Paragrafo to numeral 7 repeats that condition for prohibited uses. Invima's own public servants, contractors and collaborators are separately subject to mandatory compliance within their functions or obligations. Read the agreement and any incorporated terms; obtain legal advice where their scope or application is uncertain.
Is this an approval route or a classification rule for AI-enabled medical devices?
No. The circular governs how artificial intelligence is used in Invima's own processes and, where contractually incorporated, by counterparties with access to its systems. It does not create, modify or describe any marketing authorisation, sanitary registration or device classification pathway, and it says nothing about software as a medical device.
Does it ban artificial intelligence from regulatory decision-making?
The circular permits assisted work while retaining human responsibility for decisions. Numeral 7(a) prohibits adopting final administrative decisions with legal effects automatically and without human intervention, numeral 7(b) prohibits letting AI substitute the reasoning of an administrative act, and numeral 10(b) requires a competent public servant to adopt or validate any definitive decision with significant legal or material effect and to carry responsibility for it. Assisted drafting stays available, subject to the verification and traceability rules in numeral 8.
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