Mandatory medical device registration in Argentina is primarily regulated by:

• Disposición ANMAT 2318/2002 (Mercosur Technical Regulation for the Registration of Medical Products) and its subsequent amendments, which specify the technical, procedural, and documentary requirements for registration.
• Disposición ANMAT 2319/2002, which governs manufacturing, import authorizations and related costs.

Registration Procedure

1. Application Submission
   The Authorized Agent in Argentina (AAR – Autorizado en Argentina) submits the registration application to ANMAT’s Medical Device Registry Office (specifically, the Subdirección de Registro de Productos Médicos).
2. Preliminary Evaluation
   The Medical Device Registry Office conducts a preliminary formal review within 10 consecutive days, checking the completeness of the documentation and the formal correctness of the application. In case of incomplete or irregular dossiers, it notifies the need for additional information.
3. Technical Evaluation
   The complete documentation is passed to the Dirección de Evaluación y Control de Productos para la Salud (DECYPSA), which performs the technical evaluation of the device’s safety, efficacy, and quality. DECYPSA may request supplementary tests, inspections, and clarifications.
4. Inspection (if required)
   For Class III and IV devices, or in some cases for Class II devices, ANMAT may request inspections of the manufacturing site to verify Good Manufacturing Practices (GMP – Buenas Prácticas de Fabricación), in accordance with Mercosur regulations.
5. Issuance of the Registration Certificate
   Following a positive evaluation, ANMAT issues the Registration Certificate authorizing commercialization in the Argentine market.

Applicant

Manufacturers not established in Argentina must appoint an Authorized Local Representative (AAR) based in Argentina, who:

• Submits and manages the registration application with ANMAT.
• Assumes legal responsibility in Argentina.
• Is the formal holder of the Registration Certificate.

Registration Timelines and Costs

• The technical evaluation has a maximum legal term of 180 consecutive days, but actual times can vary from 12 to 18 months or more, depending on the device class, completeness of the dossier, any inspections, and requests for additional information.
• Costs vary based on the device’s risk class and are regulated by Disposición 2319/2002 and its subsequent amendments. These costs must be paid at the time of application and renewals to continue the registration process.

Certificate Validity

• 5 years. Renewal must be requested within 90 days prior to the expiration date.

Documentation Language and Labeling

• Technical Documentation: must be provided in Spanish, through official or sworn translations.
• Labeling and IFU (Instructions for Use): spanish.

Useful Information

The AAR is the legal holder of the registration with ANMAT. The termination of commercial relations with the current AAR means that the existing registration will become invalid, and it will be necessary to restart the entire registration process from the beginning with a new AAR. This aspect makes the selection of a reliable local partner of fundamental importance.

Any significant change to the device or manufacturing process (e.g., change of production facility, substantial modification of design, material, or indications for use) must be notified to ANMAT and obtain prior approval before its implementation. This modification may require documentation updates or, in extreme cases, a new registration.