ANMAT Provision – No. 236/2026
Healthcare & Life Sciences Department Report |ANMAT Provision – No. 236/2026.
Dear all,
On February 6, 2026, Provision No. 236/2026 (the “Provision“) was published in the Official Gazette, through which the National Administration of Drugs, Food and Medical Devices (the “ANMAT“) regulates Decree No. 892/2025, establishing the applicable mechanisms for the importation and commercialization in the Argentine Republic of certain products of foreign origin subject to health control.
Decree No. 892/2025 introduced a general framework aimed at simplifying the procedures for certifying compliance with technical requirements for the importation and commercialization of regulated products, through the recognition of international regulatory equivalences, the acceptance of certifications issued by health authorities and accredited organizations from reference countries, and the reduction of administrative redundancies, without prejudice to the maintenance of quality, safety and efficacy standards in force in the country.
In this context, the Provision implements said regime within the scope of ANMAT, introducing a prior notification system in the form of an affidavit.
The Provision applies to the following foreign products that comply with the definitions, formulation requirements, labeling, quality, safety and efficacy or performance established by current national regulations: (i) medical devices of risk class I and II; (ii) in vitro diagnostic medical devices (IVD) of risk class A and B that do not require cold chain; (iii) household sanitary products; (iv) oral hygiene products for dental use; (v) personal hygiene products, cosmetics and perfumes; (vi) disposable hygienic products for external use; and (vii) hygienic products for intravaginal use.
Likewise, it is established that the covered products may only be imported and commercialized in the national territory by companies duly authorized by ANMAT, and provided that they are authorized and registered with said authority through an affidavit procedure in the form of prior notification, implemented through the digital platforms enabled for that purpose.
The Provision exempts from local testing those products covered by it that also have authorization for commercialization in at least one of the reference countries or regions indicated in Annex I of the Decree No. 892/25 (Australia, United States, Israel, Japan, United Kingdom, Member States of the European Union and the European Free Trade Association). For these purposes, a Free Sale Certificate issued by the competent health authority of the country of origin must be submitted, with a validity of no more than twenty-four (24) months.
If such authorization cannot be evidenced, the requirements shall be deemed fulfilled when the products have certifications or test reports issued by recognized certifying bodies or by laboratories accredited by the Argentine Accreditation Body; failing that, registration with ANMAT must be carried out in accordance with the current technical requirements applicable to each product category.
Non-compliance with the Provision will give rise to the initiation of the relevant summary proceedings and the application of sanctions in accordance with Laws No. 16,463 and No. 18,284, without prejudice to the preventive measures that may apply pursuant to Decree No. 341/92 and complementary regulations.
Finally, this Provision will enter into force thirty (30) days following its publication in the Official Gazette, in accordance with the provisions of Decree No. 892/25.
Kind regards,