Argentina Announces Simplified Approval Process for Low-Risk Medical Products

Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) has introduced a new measure to streamline the approval process for manufacturers and importers of low-risk medical products. Disposición 8799/2025 allows businesses involved in the production and importation of Class I and II medical devices and in vitro diagnostic (IVD) products categorized as A and B to opt for a simplified procedure to gain national health authorization.

Under the new framework, companies can submit a sworn declaration (Declaración Jurada) through a digital platform, thereby expediting the process. The system will assign a unique registration number upon submission. The new procedure is designed to enhance public sector efficiency while ensuring that companies adhere to established Good Manufacturing Practices (GMP), ensuring the safety and quality of the products.

The resolution also mandates that all medical product companies must maintain up-to-date documentation, including legal ownership, municipal authorization, and health certifications. Furthermore, these businesses will be subject to periodic inspections by ANMAT to ensure compliance with health standards.

In addition to simplifying approval, the measure empowers businesses to continue operating in their declared facilities while awaiting future inspections. Companies are also required to report any significant changes to their business activities within 30 days, ensuring that all regulatory information remains current.

Despite the simplified process for low-risk products, those involved in manufacturing and importing higher-risk medical devices (Class III and IV) and IVDs classified as C and D will still need to comply with the more detailed procedural requirements outlined in previous regulations.

Failure to comply with these new regulations may result in penalties, including administrative sanctions and potential civil or criminal responsibilities. This move is expected to improve Argentina’s healthcare system by promoting both safety and efficiency in medical product regulation.

For further information, you can find the Provision here (in Spanish).