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
ClassificationExamplesRisk Level
Class ISimple surgical instruments, tongue depressorLow
Class IIDigestive catheters, infusion pumps, and powered wheelchairsLow-Moderate
Class IIIDialyzers, and orthopaedic implantsHigh-Moderate
Class IVCoronary stentsHigh
Premarket Approval Process
Class IClass IIClass IIIClass 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
ValidityFive years
Postmarket Surveillance Must report adverse events and device recalls. Post market studies
LanguageDocuments and Labeling must be in Spanish.
Expected TimeClass 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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