SaMD Classification under Rule 11 of GMC 25/21

1. Key takeaways

The classification of software as a medical device (SaMD) in Argentina is determined by Rule 11 of Annex II of GMC 25/21, with a four-tier logic:

The three accompanying points deserve attention in the order given. First, the definition of a medical device in Disposición 64/2025 names computer programs explicitly, so the regulatory status of a mobile app is settled by the definition itself, not by the distribution channel. Second, software embedded in a device and software sold independently are analyzed separately: the standalone product follows Rule 11 on its own facts. Third, the strictest-rule principle prevents a multi-function product from being fragmented into low-class filings — each function is assessed, and the product as filed carries the highest resulting class.

Three accompanying points apply: mobile apps that meet the definition are SaMD as well; software that does not form part of a medical device is classified independently; and where the same software is captured by multiple rules, it is classified under the strictest rule and the highest class. Together these three points mean the analysis is always conducted at the level of the individual function, never at the level of the product family or the app store listing.

2. Legal basis

The instruments below cover the classification rule, the definitional source, the ANMAT wearables clarification, and the technovigilance regulation whose reporting duties apply to software on the same terms as hardware.

3. Expert insights

Insight one: the determination order of Rule 11 is purpose first, consequences of misjudgment second. The first layer asks whether the software informs therapeutic or diagnostic decisions or monitors physiological processes; only the second layer evaluates the severity of the consequences of a misjudgment. The common company error is to qualify the product simply by whether it involves diagnosis and to skip the consequence tier, which leads to systematic under-estimation of the class. Walking the two layers in the written order is what makes the conclusion defensible in review.

Insight two: on September 10, 2026 ANMAT expressly brought health apps in wearable devices within the regulatory boundary. Clinically validated atrial fibrillation detection ECG algorithms, continuous pulse rate analysis with irregular rhythm notifications, sleep apnea detection analysis software compliant with the standards of international reference institutions, and systems detecting cardiac arrest or pulselessness that trigger emergency alerts are all within the scope of functions requiring registration. The announcement set no new compliance date; the relevant standards have applied since the entry into force of Disposición 64/2025, so no grace period should be assumed.

Insight three: the vigilance obligations for SaMD are identical to those for hardware devices. The technovigilance obligations of Disposición 8194/2023 do not distinguish between software and hardware. A decline in algorithm performance in a particular population is an event that requires someone to detect it and report it; the company must determine, before launch, who judges whether the reporting threshold has been reached and on what evidence.

4. Practical recommendations

1. Fix the intended purpose before discussing registration. Write the target population, users, clinical scenario, source of input data, output content and what the clinician or user does next into a single testable statement, and keep the instructions for use and the in-app copy aligned on the same formulation.
2. Issue a written classification justification under Rule 11. Work through each question in turn — whether the software informs therapeutic or diagnostic decisions, the tier of consequences of misjudgment, whether vital sign monitoring is involved, whether functions should be split into separate filings — with every conclusion traceable to the rule text.
3. Connect version control to the regulatory ledger. Define the correspondence between model weights, decision thresholds, software versions and registration numbers, and define which updates constitute notifiable changes before they occur.
4. Designate a vigilance owner before launch. Who collects user complaints and erroneous outputs, who judges whether the reporting threshold is reached, and who submits in ARGOS — all three questions must have names attached before the product goes live.

Because SaMD evolves after release in a way hardware does not, the vigilance design also has a documentation dimension. The decision logic that a company builds before launch — who collects what, against which threshold, reported through which channel — should be written into the quality system and mapped onto the product’s version history, so that when an algorithm update changes the population in which the model performs, the change reaches the vigilance owner as an input rather than as a surprise discovered in user feedback.

5. Verification checklist

• □ Two-layer purpose-consequence determination completed under Rule 11
• □ The classification justification report states the rules triggered and the strictest-rule basis
• □ Applicability of the ANMAT wearable device announcement of September 10, 2026 assessed
• □ Intended purpose consistent across channels (instructions for use, app, website, app store)
• □ Ledger linking model versions, software versions and registration numbers established
• □ Responsible persons and trigger process for technovigilance reporting designated

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.