Risk Classification: Class I to IV under GMC 25/21 Annex II

1. Key takeaways

Medical devices in Argentina are classified by risk into four levels: Class I (low risk), Class II (low-to-medium risk), Class III (medium-to-high risk) and Class IV (high risk). The determination is based on the 22 classification rules of Annex II of GMC 25/21, executed in four groups:

1. Non-invasive rules (Rules 1–4): contact with breached skin or mucous membranes, storage or channeling of blood, body fluids or gases, and similar situations;
2. Invasive rules (Rules 5–8): graded by whether invasion occurs through body orifices or surgically, and by transient, short-term or long-term use;
3. Active rules (Rules 9–13): therapeutic devices, diagnostic and monitoring devices, software (Rule 11), and devices for administering medicines;
4. Special rules (Rules 14–22): drug-containing components, contraception, disinfection and sterilization, X-ray imaging, devices incorporating cells or tissues, nanomaterials, inhalational drug delivery, and similar.

The four rule groups are not applied in isolation. A typical device passes through several groups in sequence: the non-invasive rules are examined first, then invasiveness, then active status, and finally the special rules, which override the earlier groups where they apply. The special group is where unexpected escalations hide — a device that resolved to Class I under the general rules can move to a higher class the moment a special rule is triggered, for example by the presence of a drug-containing component or a nanomaterial.

Two key time scales apply throughout: transient means less than 60 minutes of continuous use; short-term means continuous use of 60 minutes to 30 days; and long-term means more than 30 days. Because every invasive rule uses these thresholds, the declared duration of use is never a neutral descriptive detail — it is a classification input.

2. Legal basis

The instruments below locate the classification rules in the regional annex, and the domestic transposition and registration regulation through which those rules are applied in Argentina.

3. Expert insights

Insight one: classification is rule-driven, not list-driven. Argentina has no consultable product classification catalogue; companies must work through the 22 rules themselves and argue the conclusion in writing. This means the responsibility for the classification conclusion lies with the company, and what reviewers examine is the quality of the reasoning rather than the result. A conclusion without a documented rule-by-rule justification is treated as no conclusion at all.

Insight two: the 60-minute and 30-day thresholds are the common variables of all invasive rules. The same product can span two risk classes purely because of the duration of use. How a company defines a single continuous use session in its instructions for use materially affects the classification conclusion — and this must be aligned with the real clinical scenario; it cannot be artificially shortened to reach a lower class. Reviewers compare the stated duration against the intended clinical pattern, and inconsistencies invite questions that delay the file.

Insight three: where classification is uncertain, the official route is the consultation on unclassified products. Part Two, Article 2 of GMC 25/21 provides that where classification is in doubt, the competent health authority decides. Companies can submit the consultation through the TAD system and receive an ANMAT opinion before filing. The cost of asking once is far lower than the cost of a reversed classification that forces re-registration, and the written opinion also protects the original decision if the file is later challenged.

In practice, the consultation route also has a defensive value. Once ANMAT has issued a written opinion on a genuinely borderline product, the company can point to that opinion if the classification is ever re-examined during a change, a renewal or a market surveillance action. The alternative — arguing the class alone and hoping the reviewer agrees — leaves the company exposed to a reversed conclusion mid-review and the cost of re-submitting the whole dossier under a corrected class. Budget for this conversation in the project plan from the outset, and record the exchange in the regulatory file.

4. Practical recommendations

1. Compare rule by rule across five dimensions. Intended purpose, invasiveness, duration of use, contact with the heart or central nervous or circulatory system, and whether the device is active — record the determination basis for each dimension and produce a written classification justification report.
2. Apply the strictest rule when several apply simultaneously. Where a product is captured by multiple rules, classify at the highest risk level and list every rule triggered in the justification report, so the logic is transparent and auditable.
3. Keep the time scales consistent with the instructions for use. The duration-of-use thresholds used in the classification justification must correspond exactly to the wording in the instructions for use and on the label.
4. For borderline products, prefer the official consultation. For products at the boundary between aesthetic medicine, health management, consumer electronics and medical devices, submit the unclassified-product consultation through TAD first and retain the communication record.

5. Verification checklist

• □ Determinations completed rule by rule against the 22 rules of Annex II of GMC 25/21
• □ The classification justification report lists every rule triggered and the strictest-rule basis
• □ The duration-of-use thresholds (60 minutes / 30 days) are made explicit in the justification
• □ The classification conclusion is consistent with the instructions for use and labeling
• □ Borderline products have been submitted to the official TAD classification consultation and archived
• □ The classification conclusion has been carried into pathway selection and the document list

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.