IVD Registration and Group A–D under Disposición 2198/2022

1. Key takeaways

In vitro diagnostic products (IVDs) in Argentina are not within the scope of GMC 25/21. They are regulated separately by Disposición ANMAT 2198/2022 and classified by risk into Groups A, B, C and D. Labeling requirements must additionally comply with Disposición ANMAT 2674/99, so every IVD label has to satisfy two layers of rules simultaneously.

Typical assignments of the four groups: Group A covers items such as buffer solutions, diluents, culture media and sample preparation instruments; Group B covers instruments providing analytical quantitative results (other than self-testing use); Group C covers blood grouping and tissue typing; and Group D covers detection of blood-borne transmissible pathogens and pathogens with a high case-fatality risk. The grouping is driven by what the assay detects and for whom, not by the technology platform.

Because the grouping determines the pathway — declaration of conformity for Groups A and B versus full technical review for Groups C and D — the group determination should be completed and documented before any filing work begins, and revisited whenever the intended use population or the target analyte changes.

The exclusion of IVDs from GMC 25/21 is not a drafting detail — it is stated in the scope of Part One of the regional regulation, and Disposición 64/2025 does not change it. Everything in that transposition, including the 22 classification rules of Annex II and the annexed document and labeling formats, applies to devices only. An IVD project team that borrows the device framework by reflex will therefore build its dossier on rules that have no application to its product, and the error is usually discovered only when the reviewer asks for the Group A/B/C/D determination that the file never made.

2. Legal basis

The instruments below include the IVD registration regulation and its grouping rules, the dedicated labeling regulation, the regional technical regulation whose scope excludes IVDs, the transposition instrument, and the 2026 notification regime that covers part of the low-group IVD space.

3. Expert insights

Insight one: IVDs run on a separate track, which means reagent classification cannot follow device thinking. The 22 rules of GMC 25/21 do not apply to IVDs; grouping under Disposición 2198/2022 is based on the risk attributes of what is being detected, not on invasiveness and duration of use. Classifying a reagent with the device rules is a high-frequency error, and it usually surfaces only at review, when the file must be rebuilt around the correct grouping logic.

Insight two: the filing pathways for Groups A/B and Groups C/D diverge clearly. Groups A and B follow the declaration of conformity pathway, while Groups C and D undergo full technical review. The split corresponds structurally to the Class I/II versus Class III/IV split for devices, but the threshold differs — Group D requires a detection protocol of at least 100 cases, an additional requirement specific to IVDs. Planning that omits this evidence workload will miss the filing date even when the rest of the dossier is ready.

Insight three: Disposición 236/2026 brought Group A/B IVDs that do not require cold chain into the notification channel. This is a new convenience added in 2026: qualifying Group A/B IVDs meeting the reference-country conditions may be exempted from local testing. The cold-chain requirement becomes a new dividing line — Group A/B IVDs requiring cold chain remain on the regular pathway, so logistics design and regulatory strategy must be decided together.

4. Practical recommendations

1. First determine IVD status, then the group. Confirm whether the product falls within the definition of in vitro diagnostic products under Disposición 2198/2022 (reagents, calibrators, control materials, sample collection devices, software, instruments and similar), then locate it under the four-group rules.
2. Prepare the detection protocol early for Group D. The protocol of at least 100 cases must be compiled together with the registration dossier — it cannot be patched in during review as a deficiency response.
3. Apply the dual-track labeling requirements. The labeling requirements of Disposición 2674/99 apply in addition to the general requirements, and the instructions for use and the label must satisfy both simultaneously.
4. Evaluate the notification channel for Group A/B. Where a reference-country market authorization has been obtained and cold chain is not required, evaluate the sworn notification pathway of Disposición 236/2026, but first confirm that the CFS is valid for no more than 24 months.

The same logic runs in reverse for grouping inside the IVD track. Grouping follows the assay’s risk profile: what the test detects, in which population, and with what consequence of a wrong result. A company changing a product’s intended use — for example extending a Group B quantitative instrument to self-testing use — does not merely amend a filing; the self-testing exclusion moves the product out of Group B, so the grouping determination and the pathway must be reworked. Keep the grouping justification as a living document tied to the intended use statement.

5. Verification checklist

• □ Confirmed the product falls within the IVD scope defined by Disposición 2198/2022
• □ Group A/B/C/D determination completed and the basis recorded
• □ Detection protocol of at least 100 cases compiled for Group D products
• □ Labeling satisfies both Disposición 2674/99 and the general requirements
• □ Applicability of the Disposición 236/2026 notification regime for Group A/B assessed
• □ Spanish-language instructions for use and labeling localized

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.