ANMAT: GOOD PRACTICES FOR MEDICAL PRODUCTS MANUFACTURING

Provision 3266/13 issued by the ANMAT establishes the MERCOSUR Technical Regulations for Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use. In turn, and understanding sterilization processes as a necessary part of the manufacture of a sterile medical product, compliance with this regulatory requirement is mandatory for a Company that performs Sterilization of Medical Products in Argentina to fit within the legal framework current, giving in turn the necessary legal coverage necessary to its customers. In that sense, having been Asisthos the first company of its category enabled before the Department of Medical Technology of ANMAT for the sterilization of Medical Products, we present our clients our new certificate in accordance with the last Disposition already mentioned.

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