Medical Device Definition under Disposición ANMAT 64/2025

1. Key takeaways

The current Argentine definition of a medical device, under Disposición ANMAT 64/2025, reads as follows: any instrument, apparatus, machine, implant, in vitro diagnostic product, computer program (software), material or other item, intended by the manufacturer to be used on human beings, alone or in combination, for a specific medical purpose, and whose principal intended action is not achieved by pharmacological, immunological or metabolic means (although such means may assist its function).

The definition contains 3 determination criteria and 6 categories of medical purpose. The express inclusion of computer programs (software) in the body of the definition is the most substantive difference from the old framework, and it is the starting point for the compliance assessment of any digital health product intended for the Argentine market.

In practical terms, the definition operates as a gate. If a product passes all three criteria and its intended purpose falls within at least one of the six categories, it is a regulated medical device in Argentina, whatever its form — a physical instrument, a consumable, a mobile application or an embedded algorithm. If it fails the gate, it falls outside device regulation, and the analysis should be documented so the negative conclusion is defensible.

2. Legal basis

The instruments below provide the definitional source, the regional annex containing the definitions, the ANMAT clarification on wearables, and the separate IVD registration regulation whose own definition matters for diagnostics.

3. Expert insights

Insight one: the principal intended action in the definition is the dividing line. Pharmacological, immunological and metabolic means may assist the product, but they must not constitute its principal intended action. Combination products containing drugs or biological materials must therefore have their principal mechanism of action determined case by case; the product name alone can never settle the question. A dressing with an antimicrobial agent and a device with a steroid coating sit on opposite sides of the line depending on what actually does the work.

Insight two: the six categories of medical purpose form a closed list of uses. They include: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment or compensation of injury or disability; investigation, replacement or modification of anatomy or physiological/pathological processes; support or sustenance of life; control or support of conception; and obtaining information through in vitro examination of human samples (including organ and tissue donation). A product’s intended purpose must fall within at least one of these categories, otherwise it is outside the scope of medical device regulation. Marketing claims that drift outside the list can silently pull an unregulated product into the regulated space.

Insight three: definitional convergence lowers the conversion cost for CE-certified companies. This definition aligns closely with the definition under the EU MDR in structure, criteria and the list of purposes. Companies holding CE technical documentation can carry over their intended purpose descriptions and scope statements directly, and only need to add Argentine local language and certificate-holder information — a modest increment compared with drafting from scratch.

4. Practical recommendations

1. Fix the intended purpose first, then judge the regulatory nature. Write the target population, users, clinical scenario, source of input data and output content into a single testable statement, and keep the instructions for use, in-app copy, website and app store listings aligned on the same formulation.
2. Assess software-containing products independently. Mobile apps and built-in health functions of wearable devices that meet the definition fall within the regulatory scope (the ANMAT boundary clarification issued on September 10, 2026 confirmed that health apps in wearables such as smartwatches are within the regulatory boundary); they cannot be exempted on the argument that they are merely an app.
3. Qualify combination products by their principal mechanism. For products with drug-containing components or biological materials, the pathway through which the principal intended action is achieved must be argued in writing, and the classification rules selected on that basis.
4. Establish a documentation consistency checkpoint. Once any element of the definition changes — especially the intended purpose — this should trigger a re-run of the classification assessment and an evaluation of whether a change notification is required.

5. Verification checklist

• □ Product characteristics checked item by item against the definition in Disposición 64/2025
• □ Confirmed that the principal intended action does not rely on pharmacological, immunological or metabolic means
• □ Intended purpose falls within a specific one of the six categories of medical purpose
• □ Software components have undergone an independent medical device qualification
• □ Applicability of the ANMAT wearable device announcement of September 10, 2026 has been assessed
• □ Purpose statements across all channels are consistent with the registration documents

Regulatory information verified as of October 29, 2026.

In Argentina, GRZAN operates a wholly owned subsidiary that can act as the registration holder and importer for foreign manufacturers, directly undertaking classification determination, pathway selection, GMP and CFS documentation chains, Spanish-language localization of technical documentation and labels, HELENA submissions and deficiency responses, as well as BONITA import notifications, operation of the ARGOS vigilance system, change maintenance and 5-year renewal planning.

The GRZAN regulatory team consists of professionals with many years of hands-on international registration experience and continuously tracks the developments of regulatory authorities worldwide; all published content follows the editorial standard of conclusions first, traceable bases and verifiable figures. For a tailored market access plan for Argentina or the MERCOSUR region covering a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.