Argentina Medical Device Regulations

Medical Device Definition

Medical Device: product for health like equipment, apparatus, material, article or system for medical, dental or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation or contraception; and which does not use pharmacological, immunological or metabolic means to perform its function in human beings, although allowing to be assisted in their function by such means.

Active Medical Device: any medical product whose functioning depends on a source of electrical energy or any other power source other than that generated by the human body or gravity and which functions by converting this energy. Active medical devices shall not be considered medical devices intended to transmit without causing any significant alteration, energy, substances, or other elements of an active medical device to the patient.

Active Medical Device for diagnosis: any active medical device, alone or in combination with other medical devices, intended to provide information for detecting, diagnosing, monitoring, or treating physiological or health conditions, diseases, or congenital deformities.

Active Medical Device for therapy: any active medical product, used alone or in combination with other medical products, intended to support, modify, substitute, or restore biological functions or structures if treating or alleviating a disease, injury, or deficiency.

Family of Medical Devices: set of medical devices, where each product has the technical specifications described in items 1.1, 1.2, and 1.3 of the Technical Report (Annex III.C of Provision No. 2318/2002 TO 2004), which are similar.

• 1.1 The information on the label and instructions for use shall be written in the language of the State Party to which the medical device registration is applied.
• 1.2 All medical devices shall include instructions for use on their packaging. Exceptionally, these instructions may not be included on the packaging of Class I and II medical devices if the complete safety of their use can be guaranteed without the aid of such instructions.
• 1.3 The information necessary for the safe use of the medical device should, whenever feasible and appropriate, appear on the medical device itself and in unit packs or, if possible, on the commercial packaging. If it is not possible to package each unit individually, this information should be included in instructions accompanying one or more medical devices.

Medical Device Classification System

Classification	Risk Level	Examples
Class I	Low Risk	Simple surgical instruments, tongue depressors
Class II	Low–moderate risk	Digestive catheters, infusion pumps, and powered wheelchairs
Class III	High- Moderate risk	Dialyzers, and orthopedic implants
Class IV	High risk	Coronary stents
In Vitro Diagnostics
Class A	Diagnosis of non-infectious or non-communicable diseases.
Class B	Diagnosis of infectious diseases except those belonging to GROUP C.
Class C	Diagnosis of sexually transmitted infectious diseases, or transmitted by blood or its derivatives, as well as for identification of blood groups.
Class D	For Self-Assessment.

Regulatory Approval Process

Additional Information