Argentina Medical Device Regulations

Regulatory Agency

The National Administration of Drugs, Foods, and Medical Devices (ANMAT) regulates medical devices in South Argentina.

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	Low Risk	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

Classification	Approval procedure
MD Class I	Appoint a local authorized representative in Argentina Manufacturer must insert all the details in the Declaration of Conformity (Only for Class I and II) document. Submission of the dossier for class I and II Medical Devices is done through the HELENA system. Start loading files for the submission; all files must be in pdf format and digitally signed by Legal Representative and Technical Director. The National Institute of Medical Products (INPM) will have 15 (FIFTEEN) to 30 (THIRTY) administrative business days to evaluate the documentation for Classes I and II. And 60 (SIXTY) to 110 (ONE HUNDRED AND TEN) business days to evaluate Classes III and IV. If the application is approved, ANMAT will grant the registration.
MD Class II
MD Class III
MD Class IV
IVD Class A	Appoint a local authorized representative in Argentina. Submission of “General Information” and a “Dossier” with the technical information of the product and the Labeling and Instruction Manual sections through the HELENA system. Start loading files for the submission, all files must be in pdf format and digitally signed by Legal Representative and Technical Director. The National Institute of Medical Products (INPM) will have 60 (SIXTY) to 90 (NINETY) business days to evaluate IVDs. If the application is approved, ANMAT will grant the registration.
IVD Class B
IVD Class C
IVD Class D

Additional Information

Approval timeline	Classes I and II 15 to 30 work days. Classes III and IV 60 to 110 work days. GMP 60 work days from the application.
License validity period	5 years
Fees	MD I- 215000 ARS, MD II- 276800 ARS, MD III- 367200 ARS, MD IV- 513000 ARS, IVD A and B- 194700 ARS, IVD C and D- 241200 ARS

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