Simplified Enterprise Qualification under Disposición 8799/2025

1. Key takeaways

Disposición ANMAT 8799/2025 was published in the Official Gazette on November 28, 2025 and takes effect 60 administrative business days after publication. It offers enterprises engaged in the manufacturing and/or import of Class I and Class II medical devices and Group A and B IVD an optional simplified qualification channel: a sworn declaration (Declaración Jurada) submitted on the ANMAT digital platform replaces the traditional approval procedures of 2319/02 (T.O. 2004), 7425/13 and 2096/22.

Two boundaries must be held firmly: Class III/IV devices and Group C/D IVD are excluded and continue through the traditional procedures; and Good Manufacturing Practice obligations under Disposición 3266/2013 are not waived by the simplification — companies choosing this channel remain subject to subsequent ANMAT inspection. The channel streamlines the paperwork, never the standards behind it.

The channel is optional, not mandatory: an enterprise within scope may still prefer the traditional procedures, for example where its product portfolio spans risk tiers or where it expects frequent changes that would make declaration maintenance burdensome. What the instrument changes is the default cost of entry for low-risk players, not the underlying obligations that continue to apply once the enterprise is operating. The two boundaries — excluded risk tiers and preserved GMP duties — define exactly how far the simplification reaches, and both should be tested against the company’s actual portfolio before electing the channel.

2. Legal basis

The instruments below establish the simplified channel, the GMP obligations it preserves, the traditional procedures it replaces, and the penalties for false declarations.

3. Expert insights

Insight 1: the sworn declaration has no expiry date, but changes must replace it with a new declaration within 30 days. This is a distinctive design: the qualification itself carries no validity period, removing the recurring burden of renewals; however, any change to the company name, legal address, industrial premises, scope of activities, addition of warehouses or plants, or replacement of the Director Técnico requires a new sworn declaration within 30 days to replace the original. The regulatory logic shifts from periodic re-verification to declare-upon-change.

Insight 2: GMP obligations are expressly preserved — direct evidence that simplified does not mean relaxed. Companies choosing the channel must still implement 3266/13, retain compliance evidence, and accept ANMAT’s scheduled or unannounced inspections. ANMAT is shifting regulatory resources from review to inspection, and the probability of inspection rises in substance.

Insight 3: the transition rules for pending applications are tightly circumscribed. Where a qualification or change application is already pending when the instrument takes effect, the company must first complete all requirements under the existing procedure; only after completion and notification by ANMAT may it switch to the new channel. Once a new sworn declaration is submitted, the original file is deemed closed (except for matters involving Class III/IV and Group C/D IVD). This prevents program-hopping midway and the procedural confusion it would cause.

Electing the channel is easy; staying compliant under it is a standing operational commitment. The ongoing burden lies in change control — five trigger categories, each carrying its own 30-day filing clock — and in keeping GMP evidence continuously retrievable for inspection. The recommendations below turn those obligations into concrete mechanisms that survive personnel changes and portfolio growth alike.

4. Practical recommendations

1. Apply the channel only to low-risk product lines. If the company also handles Class III/IV products, the traditional procedures still apply; consider splitting entities by product line before filing, or simply standardize on the traditional procedures to keep management simple.
2. Build a trigger mechanism for the 30-day change filing. Treat name, address, premises, scope of activities and Director Técnico as five change triggers; whenever any of them changes, start preparing the new declaration immediately.
3. Retain GMP compliance evidence as a standing practice. Facility and equipment maintenance, production process controls, cleaning and disinfection, material traceability, training records, and adverse event and recall procedures must be retrievable at any time.
4. Watch the transition arrangements. Companies with pending applications should complete the existing procedure before switching and never file a new declaration while in the intermediate state.

5. Verification checklist

Confirm each item below before electing the 8799/2025 channel.

• □ The scope of operations is limited to Class I/II devices and Group A/B IVD
• □ The effective date of 8799/2025 — 60 administrative business days after publication — has been confirmed
• □ A trigger mechanism for 30-day filings of the five change types is in place
• □ GMP compliance evidence under 3266/2013 is retained on a standing basis
• □ The transition rules for pending applications have been assessed
• □ A verification workflow for the truthfulness of the sworn declaration content is defined

Re-test this checklist whenever the company’s structure changes — new premises, new legal addresses, new product lines or a new Director Técnico — since each of these events starts the 30-day filing clock on its own. A standing quarterly review of the declaration content is a simple, low-cost way to keep the qualification permanently accurate.

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 handling classification assessment, pathway selection, GMP and CFS documentation chains, Spanish-language technical documentation and labeling localization, HELENA submissions and deficiency responses, as well as BONITA import notifications, ARGOS vigilance system operation, change maintenance and 5-year renewal planning.

The GRZAN regulatory team consists of professionals with many years of hands-on international registration experience and tracks the developments of regulatory authorities worldwide. All published content follows the drafting standard of conclusions first, traceable legal basis, and verifiable figures. For an Argentina or MERCOSUR market-access plan tailored to a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.