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The National Administration of Drugs, Food, and Medical Technology (ANMAT) has announced a new provision, published on May 5, 2025, in the Official Gazette.
This measure establishes that ANMAT will not intervene in the import procedures for medical products that do not require a medical prescription, provided they are purchased by individuals and intended exclusively for personal use.
The main objective of this regulation is to simplify administrative processes and improve efficiency in public administration, thus facilitating user access to medical products for personal use. The provision specifies that these products must be used directly by the patient or user, without the need for medical advice or professional intervention. However, their free marketing or distribution is expressly prohibited.
WHOM DOES THIS IMPACT?
The direct impact is on individual users, patients with specific needs, the import sector, manufacturers, and suppliers.
CONCLUSION:
The measure has a medium impact, primarily because it simplifies access to certain medical products for personal use, directly benefiting individual users and patients with specific needs, while also posing challenges in terms of liability and proper use of the products.
Regulatory Impact:
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