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Argentina Medical Device Regulations

Agency
The National Administration of Drugs, Foods, and Medical Devices (ANMAT) regulates medical devices in South Argentina.
Medical Device Definition
A medical device in Argentina is any equipment, apparatus, material, article, or system used in medical, dental, or laboratory applications for human prevention, diagnosis, treatment, rehabilitation, or contraception. The device must not use pharmacological, immunological, or metabolic means to perform its primary function, although it may be assisted by such means.
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.
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 39800 ARS MD II 51250 ARS MD III 68000 ARS MD IV 95000 ARS IVD A and B 36050 ARS IVD C and D 46150 ARS
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