By virtue of ANMAT Provision No. 236/2026, published on February 6, 2026, the National Agency of Medicines, Food and Medical Technology (ANMAT) implemented a prior notification system applicable to the importation and commercialization of certain regulated products, within the framework of Decree No. 892/2025, aimed at strengthening a regulatory trust model and administrative simplification.
The Provision applies to Class I and II medical devices, Class A and B in vitro diagnostic (IVD) products not requiring cold chain, household cleaning products, personal hygiene products, cosmetics and perfumes, oral hygiene products for dental use, external-use disposable hygiene products, and intravaginal hygiene products, all of foreign origin.
The Provision establishes that the covered products may only be imported and commercialized by companies holding a valid sanitary authorization, and that their registration and authorization process will be implemented through an affidavit-based prior notification system, to be filed through ANMAT’s digital platforms.
The Provision further provides that the covered products will be exempt from local testing requirements when they are authorized for public consumption in at least one of the reference countries listed in Annex I to Decree No. 892/2025. For these purposes, a Free Sale Certificate (FSC) issued by the competent health authority of the country of origin or provenance must be submitted, with a validity of no more than 24 months.
In cases where such requirement is not met, the applicable requirements will be deemed satisfied through certifications or test reports issued by recognized certification bodies or by laboratories accredited by the Argentine Accreditation Body.
The Provision further clarifies that, where compliance with Argentine quality or technical standards cannot be duly certified, the products must follow the ordinary registration procedure and comply with the applicable technical requirements for their respective category, as established by ANMAT.
