ANMAT Provision – No. 4446/2025 Simplification of Import Procedures for Class I and II Medical Products
Health Department – Life Sciences Department Report | ANMAT Provision – No. 4446/2025: Simplification of Import Procedures for Class I and II Medical Products
On June 24, 2025, Provision No. 4446/2025 (the “Provision“) was published in the Official Gazette, by which the National Administration of Drugs, Food and Medical Technology (the “ANMAT“) ordered the elimination of its prior intervention in the procedures for applying for authorization to import medical products classified as Risk Class I and II, both for marketing and for free distribution.
By virtue of this measure, establishments authorized by ANMAT will be able to import medical products of the aforementioned classes without requiring prior authorization from the agency, in line with the trend of simplification and administrative deregulation. The Provision also covers the importation of samples intended exclusively for exhibitions or commercial demonstrations, as well as raw materials intended for the industry of the aforementioned products.
In place of the prior authorization procedure, the Provision introduces the obligation to submit a “Notice of import” as a sworn statement. This notice must be submitted by importing establishments within 48 (forty-eight) hours of the products being nationalized, through the remote processing system (TAD) platform.
Finally, although the Provision eliminates the prior intervention of the agency, it maintains the requirement of full compliance with the sanitary standards applicable to these products, including ANMAT Provisions Nos. 2319/02 (t.o. 2004), 3266/13, 9688/19, 64/25 and their amendments and supplements.
It should be noted that this Provision is part of the line drawn by the previous regulations (Provision 4033/2025), which had already excluded the intervention of ANMAT in the import authorization procedures for certain products, such as cosmetics, household cleaning products, oral hygiene products for dental use, disposable hygiene products for external use and hygiene products for intravaginal use. In this sense, the measure reinforces the trend towards the simplification and deregulation of import procedures in the sector.
This provision will enter into force 30 days after its publication in the Official Gazette.
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