Argentina Medical Device Regulations

Agency
All medical devices are regulated by The National Administration of Drugs, Foods and Medical Devices (ANMAT).
Medical Device Definition
A medical product is a health product such as equipment, apparatus, material, item or system of application use medical, dental or laboratory, for the prevention, diagnosis, treatment, rehabilitation or that does not use contraception and pharmacological, immunological, or metabolic to perform its primary function in humans, can meanwhile be assisted in its function by such means. (Disposición 2138/2002).
Classification of Medical Device
Classification Examples Risk Level
Class I Simple surgical instruments, tongue depressor Low
Class II Digestive catheters, infusion pumps, and powered wheelchairs Low-Moderate
Class III Dialyzers, and orthopaedic implants High-Moderate
Class IV Coronary stents High
Premarket Approval Process
Class I Class II Class III Class IV
Appoint a Local Authorized Representative in Argentina that will be responsible for the registration process.
AMNAT requires a Certificate of Free Sale (CFS) from recognized country (Australia, Canada, Japan, United States, Europe).
If device does not have CFS from recognized country then a Good Manufacturing Practices (GMP), which is similar to ISO 13485 and QSR certificate will be required. A distributor or third-party company must be appointed to obtain GMP. If company selects distributor as registration holder, it is extremely difficult to switch distributors without full cooperation. It is therefore recommended that companies choose a representative that is not involved in device sale.
Brief review of a dossier. Extensive review of dossier will be performed.
If approved, device registration will be issued.
Additional Information
Validity Five years
Postmarket Surveillance Must report adverse events and device recalls. Post market studies
Language Documents and Labeling must be in Spanish.
Expected Time Class I devices: 1-2 months. All other devices: Officially the review time is 180 days for all classes of devices, however, actual review time is around one year.
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