ANMAT Regulatory Reform 2025–2026: New Paradigm for Medical Devices in Argentina

Introduction: A Wind of Change in Health Regulation

In recent months, Argentina’s National Administration of Drugs, Foods, and Medical Technology (ANMAT) has driven a series of regulatory reforms that redefine the landscape for the import, manufacture, and commercialization of medical devices. This set of regulations, issued between late 2025 and early 2026, marks a strategic shift from exhaustive pre-market control to a model of regulatory trust, administrative agility, and strengthened post-market surveillance.

This new approach not only seeks to align Argentina with the highest international standards but also to foster a more competitive, innovative, and accessible market. In this note, we will analyze the most relevant provisions and their direct impact on the health ecosystem, from both a regulatory and commercial standpoint.

The Heart of the Reform: An Analysis of the New Provisions

Four key provisions, along with the Decrees that frame them, constitute the core of this transformation. Each is broken down below to understand its scope and consequences.

1. Provision 224/2026: Flexibilization in the Import of Used Medical Equipment

This provision represents a significant change by repealing Provision 806/2007, eliminating the mandatory Certificate of Import of Used Goods (CIBU). The objective is clear: to facilitate access to quality medical technology at a lower cost.

Regulatory and Commercial Impact: The elimination of bureaucratic barriers allows both importing companies and end-users (clinics, hospitals) to import refurbished equipment. This not only dramatically reduces import times and costs but also energizes the market, allowing smaller health centers to access previously prohibitive technologies. However, the requirement for refurbishment to be carried out by authorized establishments is maintained, seeking a balance between flexibility and patient safety.

2. Provision 236/2026: Towards International Regulatory Convergence

In line with Argentina’s membership in the International Council for Harmonisation (ICH), this rule, which regulates Decree 892/2025, establishes a simplified notification system for low and medium-risk products. The most disruptive change is the recognition of marketing authorizations from countries with high health surveillance.

Regulatory and Commercial Impact: For Class I and II medical products, among others, local trials will no longer be necessary if the product has a Certificate of Free Sale from a reference health authority. This translates into an unprecedented acceleration of time-to-market. Companies will be able to introduce innovations to the Argentine market in a fraction of the time it previously took, expanding their portfolio and improving competitiveness. The regulatory focus shifts to robust post-market control.

3. Provision 8799/2025: Streamlining the Authorization of Manufacturers and Importers

This provision introduces an optional and simplified regime for the authorization of manufacturers and/or importers of low-risk medical products (Class I and II). Instead of the traditional authorization process, companies can opt for a sworn declaration system.

Regulatory and Commercial Impact: The measure is designed to reduce market entry barriers, especially for Small and Medium-sized Enterprises (SMEs). By drastically simplifying the authorization process, it encourages formalization and competition. While the requirement to comply with Good Manufacturing Practices (GMP) is maintained, the shift from pre-market control to post-market verification greatly speeds up the start of activities.

4. Provision 7516/2025: Modernization of Clinical Pharmacology Studies

By adopting the ICH E6 (R3) guideline, this regulation raises the standards for conducting clinical studies in Argentina, aligning them with the best international practices. It promotes the decentralization and streamlining of evaluation processes.

Regulatory and Commercial Impact: Although its main focus is not medical devices, this provision is crucial for the health sector as a whole. By making Argentina a more attractive destination for clinical research, it encourages investment, knowledge transfer, and the generation of local scientific evidence. This, in the long run, benefits the entire ecosystem, including the development and validation of new medical technologies.

The New Scenario in Numbers: Reduction in Time and Costs

The impact of these reforms can be quantified as a substantial improvement in efficiency. The following table summarizes the estimated benefits:

Aspect	Previous Situation	New Scenario	Estimated Benefit
Import of Used Goods	Mandatory CIBU and complex procedures	Sworn declaration in 48h post-nationalization	60-70% reduction in management time
Product Registration (Low Risk)	Local trials and evaluation (3-6 months)	Immediate notification with international endorsement	80-90% reduction in registration time
Company Authorization	Formal authorization procedure (2-3 months)	Sworn declaration with immediate effect	70-80% reduction in start-up time
Associated Costs	High (fees, management, local trials)	Significantly reduced	Estimated 50-70% reduction in costs

Conclusion: Navigating the Future of Medical Regulation

We are facing a paradigm shift that presents both significant opportunities and major challenges. The simplification of regulatory processes and alignment with international standards open the door to a more dynamic, competitive, and innovative medical device market in Argentina.

Companies that manage to adapt with agility to this new framework, understanding the nuances of regulatory trust and strengthening their own quality systems, will be in an unbeatable position to capitalize on these opportunities. On the other hand, the success of this model will critically depend on ANMAT’s ability to exercise effective and rigorous post-market surveillance, ensuring that the safety and efficacy of products are not compromised.

Undoubtedly, this is an exciting and transformative moment for the sector. As regulatory affairs professionals, our role will be key in guiding the industry through this transition, ensuring regulatory compliance while maximizing growth potential and contributing to improving access to health for the entire population.