ANMAT Regulatory Changes 2025–2026: Trust Reforms and Post-Market Control
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
Between 2025 and 2026, ANMAT issued a continuous series of new regulations, and the overall direction is a shift from strict ex-ante review toward regulatory trust combined with strict post-market control. The five core changes are as follows:
| Instrument | Publication date | Entry into force mechanism | Core action | Stage |
|---|---|---|---|---|
| Disposición ANMAT 64/2025 | January 13, 2025 | Applies upon publication | Incorporates GMC 25/21; repeals 2318/02 and 1285/04 | Product registration |
| Disposición ANMAT 4446/2025 | June 24, 2025 | 30 days after publication | Class I/II imports: prior authorization removed, replaced by an import notification within 48 hours after customs clearance | Import |
| Disposición ANMAT 8799/2025 | November 28, 2025 | 60 administrative working days after publication | Class I/II and Group A/B IVD company qualifications may use sworn declarations | Company qualification |
| Disposición ANMAT 224/2026 | February 2, 2026 | Applies upon publication | Repeals 806/2007; abolishes the CIBU; establishes a three-track import framework for second-hand/refurbished devices | Import |
| Disposición ANMAT 236/2026 | February 6, 2026 | 30 days after publication | Reference-country mutual recognition + prior sworn notification; exemption from local testing (CFS ≤ 24 months) | Import and commercialization |
In the same period, Disposición ANMAT 5461/2026, applicable from September 1, 2026, updated the fee framework; Disposición 7516/2025 adopted ICH E6 (R3) to govern clinical research.
2. Legal basis
| Regulation | Reference / number | Publication date | Provisions |
|---|---|---|---|
| Principal product registration regulation | Disposición ANMAT 64/2025 | Published January 13, 2025 in the Official Gazette | Full text; repeals provision |
| Import facilitation for Class I/II products | Disposición ANMAT 4446/2025 | Published June 24, 2025; effective 30 days after publication | Provision removing prior intervention |
| Clinical trial practice (ICH E6 R3) | Disposición ANMAT 7516/2025 | 2025 | Clinical research practice provisions |
| Simplified company qualification pathway for low-risk entities | Disposición ANMAT 8799/2025 | Published November 28, 2025; effective 60 administrative working days after publication | Sworn declaration provisions |
| Import rules for second-hand/refurbished medical devices | Disposición ANMAT 224/2026 | Published February 2, 2026 | Three import scenario provisions |
| Notification regime for low and medium-risk products | Disposición ANMAT 236/2026 | Published February 6, 2026; effective 30 days after publication | Reference-country recognition provisions |
| Fee framework update | Disposición ANMAT 5461/2026 | Applicable from September 1, 2026 | Fee schedule provisions |
3. Expert insights
Insight 1: The five changes belong to three different stages but point to the same paradigm migration. What 64/2025 replaced is the parent text of product registration; what 8799/2025 simplifies is company qualification; 4446/2025, 224/2026, and 236/2026 reshape import and commercialization. All three stages are moving simultaneously from ex-ante approval to ex-post supervision. This is not a set of scattered adjustments but a systemic reform, and it should be planned for as such: companies that treat each Disposición as an isolated patch will keep repatching, while those that redesign their Argentina operating model around post-market scrutiny will be aligned with where the regulator is going.
Insight 2: Every simplification expressly preserves GMP, product standards, and penalty intensity. 8799/2025 preserves the GMP obligations of Disposición 3266/2013; 4446/2025 preserves full compliance with 2319/02, 3266/13, 9688/19, and 64/25; 236/2026 cites the penalty provisions of Ley 16.463 and Ley 18.284. The accurate characterization of this reform round is: the regulatory moment has moved later; the regulatory intensity has not changed. The savings at the front end are real, but they are financed by a heavier burden of demonstrable compliance at any moment an inspector arrives.
Insight 3: The biggest beneficiaries of this reform are Class I/II products that already hold reference-country market approvals. The reference-country mutual recognition channel of 236/2026 is most valuable for products already marketed in the EU, the United States, the United Kingdom, Japan, Australia, Israel, or EFTA. For companies holding only an NMPA export certificate from the Chinese mainland, this channel is essentially unreachable, and they should continue on the conventional registration path. Portfolio planning should therefore segment products by reference-market status before choosing pathways, rather than assuming the new channels apply uniformly.
4. Practical recommendations
- Build an impact assessment matrix of stage by instrument. Map the five new instruments onto the company’s three stages of product registration, company qualification, and import, marking the affected product lines and required actions.
- Recompute the pathway of every project in progress. Projects launched in 2026 should be re-evaluated under the new instruments, especially import and commercialization arrangements for Class I/II.
- Make GMP and document retention routine actions. With the front end simplified, ex-post inspection becomes the primary regulatory instrument, and compliance evidence must be retrievable at any time.
- Set up a quarterly regulatory review mechanism. This reform round is still advancing; review the ANMAT website and the Official Gazette quarterly, and complete the assessment of affected documents and products within 30 days of any new Disposición.
5. Verification checklist
- □ An impact assessment matrix of stage by instrument has been established
- □ The impact of the parent-text replacement by 64/2025 on projects in progress has been confirmed
- □ The reshaping of the Class I/II import process by 4446/2025 has been confirmed
- □ The applicability of 8799/2025 to the company qualification pathway has been assessed
- □ The applicability and exclusions of 224/2026 for second-hand/refurbished business have been confirmed
- □ The feasibility of the 236/2026 reference-country channel has been assessed
- □ A quarterly regulatory review mechanism has been set up
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 label 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, tracking the developments of regulators worldwide. All external content follows the drafting standard of conclusions first, traceable basis, and verifiable numbers. For a market access plan tailored to your specific product for Argentina or the MERCOSUR region, contact the GRZAN regulatory team at info@grzanglobal.com.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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