Argentina Medical Device Regulation

Regulatory Authority:Direccion de Tecnologia Medica, Administracion National de Medicamentos, Alimentos yTecnologia Médico (ANMAT)

The National Institute of Medical Products (ANMAT) has implemented measures to ensure the safety and effectiveness of medical products. These include the Technovigilance Program, which evaluates adverse events after authorization and commercialization, and the “MERCOSUR Technical Regulation of Good Manufacturing Practices for Medical Products and/or Products for Diagnostic Use in Vitro.” The Directorate of Post-Marketing Surveillance and Regulatory Actions is created within ANMAT, requiring companies holding the Medical Products Registry to implement a post-marketing monitoring system. The ANMAT also establishes requirements for medical product registration in the Registry of Producers and Medical Technology Products.

Link for Regulatory Authority:https://www.argentina.gob.ar/anmat

Local Regulation:

• DisposiciónNo 2124/11 (2011) (https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-2124-2011-180851 )
• Techno Vigilance Program for Medical Devices
• ANMAT Disposición 2318/2002 Medical Device Registration (2004)
• Disposición No 727/13 (2013)
• MERCOSUR/GMC/RES. No72/98 Provision No. 9688/2019

Classification:Class I,II,III,IV

Listing or Registration Requirements:

• Appoint a local authorised 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.
• If the application is approved, ANMAT will grant the registration.

Documents Required for Registration:

• Declaration of Conformity
• Device classification information
• Manufacturer Information
• Labelling &IFU
• Technical File
• Certificate of Free Sales or Foreign Govt. certificate
• Local Authorized Representative shall ensure that the importing medical device complies with customs regulations and procedures.
  • Filing the necessary documentation, such as a commercial invoice, packing list, and shipping documents, with the Argentine customs authorities.
  • Devices must be registered and approved before they are imported into Argentina

Registration Timeline:

• Complete registration and approval: 12-15 months
• Application review process along with technical documents:
  • Class I and II devices – 15 to 30 working days
  • Class III and IV – 60 to 120 working days

Registration Fee:

• Medical Devices:
  • Class I (Non-sterile and without measurement functions): No registration fee, only submission of a simplified notification through the HELENA system.
  • Class I (Sterile or with measurement functions): 39,800 ARS.
  • Class II: 51,250 ARS.
  • Class III: 68,000 ARS.
  • Class IV: 95,000 ARS
• In Vitro Diagnostic Medical Devices (IVDs):
  • Class A and B: 36,050 ARS.
  • Class C and D: 46,150 ARS

License Validity:5 years

Special Labelling Requirements:All documentation and labeling must be in Spanish.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]