On Tuesday, December 16, 2025, Decree No. 892 of the National Executive Branch (“PEN”) was published in the Official Gazette (B.O.) (https://www.boletinoficial.gob.ar/detalleAviso/primera/336319/20251217), whereby amendments were introduced with a view to simplifying the mechanisms for demonstrating compliance with technical requirements applicable to the importation and commercialization of goods in Argentina.
The regulation provides that technical requirements shall be deemed fulfilled when the goods meet any of the following conditions:
- Compliance with the requirements for entry and/or commercialization in at least one country or group of countries listed in ANNEX I (the United States of America; the countries that are members of the European Union and EFTA; the United Kingdom; Japan; Australia; and Israel).
- Possession of a certificate issued by a Certification Body or test reports issued by an Accredited Laboratory, evidencing or verifying compliance with the quality requirements and/or technical standards required in Argentina.
With respect to products regulated by ANMAT, the aforementioned compliance accreditation mechanisms are limited to: Class I and II medical devices; oral hygiene products for dental use; personal hygiene products; cosmetics; perfumes; disposable hygienic products for external use; and intravaginal hygienic products.
As regards products subject to supervision by SENASA, the regime applies to: phytosanitary products; veterinary therapeutic products; and preparations intended to stimulate the immune response in animals.
The decree also establishes exclusions. The goods excluded from its scope include, inter alia, weapons, explosives and chemical substances; used and/or reconditioned goods; products without industrial processing; certain food products; medicines; fertilizers; and goods subject to special laws that provide for their own specific accreditation requirements.
The regulation defines the conditions that certificates and laboratories must meet in order to be validly recognized under the regime.
Enforcement shall be carried out by the General Directorate of Customs, which shall be responsible for supervising the importation of the goods covered by the decree.
Finally, the National Executive Branch instructs all agencies of the National Public Sector to adapt their regulations, guidelines, and systems to the provisions of this decree within a maximum period of thirty (30) days from its publication in the Official Gazette.
The measure shall enter into force sixty (60) days after its publication in the Official Gazette. However, the application of the mechanism allowing the accreditation of technical requirements through test reports issued by Accredited Laboratories shall become effective only upon the issuance by the Secretariat of Industry and Commerce of the complementary regulation establishing the conditions necessary for its implementation.