Argentina IVD Submission: Group Pathways and the Group D Testing Protocol

1. Key takeaways

Argentine IVDs are governed separately by Disposición ANMAT 2198/2022, and the submission pathway is divided by group: Groups A/B go through the declaration of conformity, while Groups C/D go through full technical review.

The review timelines are tiered accordingly: 15 administrative working days for IVD Groups A/B; 60–90 working days for Groups C/D; and 110 administrative working days for Group D, which must additionally attach a testing protocol covering at least 100 samples. This extra requirement for Group D is the only quantitative threshold in the IVD submission framework, and it shapes project planning more than any other single rule in the regime, because the protocol depends on external clinical cooperation that cannot be accelerated at will.

The group determination is therefore the first and most consequential decision in an Argentine IVD project. It fixes the pathway, the review speed and, for Group D, the only hard quantitative requirement in the entire regime. Determining the group early, and documenting the reasoning behind it, keeps every downstream workstream, from testing to labeling to timeline commitments, anchored to the same classification.

2. Legal basis

Together these instruments define both the route and the speed of an IVD submission: Disposición ANMAT 2198/2022 assigns products to groups and fixes the procedure and timelines, Disposición ANMAT 2674/99 governs labeling, and the combination of Decreto 892/2025 and Disposición ANMAT 236/2026 opens the notification route for a defined subset of A/B-group products.

For an IVD portfolio, the table suggests a two-track planning model: the C/D track, where the dominant variables are the testing protocol and the long review windows, and the A/B track, where the dominant variable is whether the product can qualify for the notification route. Running the two tracks with different templates, different timelines and different evidence strategies prevents the slower track’s assumptions from inflating the faster one’s plans, and vice versa.

3. Expert insights

Insight 1: the Group D testing protocol covering at least 100 samples is an action that must be completed before submission. It is not a deficiency item for the review phase; it is mandatory material at the time of filing. Group D covers testing for blood-borne pathogens and pathogens with high fatality risk, so sample acquisition and protocol design require the cooperation of clinical institutions, the preparation period is long, and the workstream should be started first, ahead of every other document.

Insight 2: the official window of 110 working days for Group D is not the project duration. As in the device regime, the official timeline excludes document preparation, the legalization chain and deficiency responses. The realistic project duration for a Group D submission should therefore be estimated by adding the preparation period and a deficiency buffer on top of the 110 working days, and communicating that practical estimate to stakeholders early so expectations are set correctly.

Insight 3: after 2026, Groups A/B have seen a divergence of pathways. Disposición 236/2026 brought A/B-group IVDs not requiring cold chain into the notification pathway, with exemption from local testing against a reference-country CFS. Cold-chain need became the new dividing line: A/B-group IVDs requiring cold chain remain on the conventional declaration-of-conformity pathway, so the same product group now splits into two different regulatory routes depending on a purely logistical property.

This pathway split also changes how the 24-month CFS cap interacts with IVD planning. An A/B-group product that qualifies for the notification route must hold a CFS compliant with the 236/2026 rule, while the same product, if it does require cold chain, is judged against the conventional default instead. The CFS procurement decision and the cold-chain assessment are therefore not independent workstreams; the first depends on the outcome of the second, and the sequence should be reflected in the project plan.

4. Practical recommendations

1. Start the testing protocol first for Group D projects. The protocol covering at least 100 samples must be prepared in parallel with the registration documents, and clinical institutions and sample sources should be contacted early, since their availability sets the pace of the whole project.
2. Split the performance verification data into analytical and clinical volumes. Compile analytical performance (precision, accuracy, detection limit, linearity, interference) and clinical performance (sensitivity, specificity, agreement rate) as separate volumes, so the reviewer can cross-reference them without untangling a mixed file.
3. Assess cold-chain status and pathway feasibility for Groups A/B. First determine whether the product truly requires no cold chain, then determine whether a reference-country CFS can be obtained; both conditions must hold before the 236/2026 pathway can be used.
4. Layer 2674/99 onto the labeling work. IVD labels must satisfy Disposición 2198/2022 and Disposición 2674/99 simultaneously, and the artwork review should check both instruments explicitly.

5. Verification checklist

• □ A/B/C/D group determination completed
• □ Group D testing protocol covering at least 100 samples completed
• □ Performance verification data organized into analytical and clinical volumes
• □ Applicable official review timeline confirmed by group (15 / 60–90 / 110 working days)
• □ Cold-chain status and feasibility of the 236/2026 pathway assessed for Groups A/B
• □ Label verified against both Disposición 2198/2022 and Disposición 2674/99

Regulatory information verified as of October 29, 2026.

In Argentina, GRZAN operates a wholly owned subsidiary that can serve as the registration holder and importer of record for foreign manufacturers, directly handling classification assessment, pathway selection, building the GMP and CFS documentation chain, Spanish-language localization of technical documentation and labeling, HELENA submissions and responses to deficiency letters, as well as BONITA import notifications, operation of the ARGOS vigilance system, change maintenance and planning for the 5-year renewal. For support with registration dossiers and conformity documentation for the Argentine market, contact the GRZAN regulatory team at info@grzanglobal.com.

The GRZAN regulatory team consists of professionals with many years of hands-on experience in international registrations, tracks the activity of regulatory authorities across markets on an ongoing basis, and applies a writing standard of conclusions first, traceable sources and verifiable figures to everything it publishes. For a market access plan tailored to a specific product in Argentina or the wider MERCOSUR region, the GRZAN regulatory team welcomes your enquiry at info@grzanglobal.com.