ANMAT Argentina Medical Device Registration

Medical device and IVD registration in Argentina is overseen by the National Administration of Drugs, Food and Medical Devices (ANMAT) and recorded in the RPPMT (Registry of Producers and Products of Medical Technology). Devices are classified by risk into Class I, II, III, and IV, with documentation requirements increasing by class. ANMAT registration requirements are outlined in Disposición 64/2025 covering medical devices and Disposición ANMAT 727/2013 (and subsequent rules).

Class I and II devices are subject to less technical scrutiny, but the legal representative must have the full dossier compiled for audits or ANMAT request. Class III and IV devices undergo a full technical review. All documentation must comply with ANMAT regulatory provisions, including labeling, IFU requirements, GMP evidence, and risk management reports.

Argentina medical device classification and registration pathways

Devices follow a four-tier risk classification (Class I–IV). Registration requirements depend on class and device characteristics. IVDs also follow a four-tier risk classification scheme (Class A-D).

Declaration of Conformity pathway (Class I and II devices)

Manufacturers must file a Declaration of Conformity (DoC) with supporting documentation. All registration documentation is submitted to ANMAT via the HELENA system.

ANMAT registration documentation requirements for DoC route include:

• National Class I & II registration fee receipt

• Registration form

• Current GMP certification

• Test declaration

• Risk management report should be available if requested

Full technical review pathway (Class III and IV devices)

Applies to all Class III and IV devices. This route requires full technical evaluation by ANMAT. The review includes assessment of labeling, testing, GMP compliance, performance and safety data, and risk management documentation. Approval is issued through a formal administrative act.

Documentation requirements for the technical review pathway include:

• National Class III or IV registration fee receipt

• ANMAT Registration form

• Current GMP certification

• Labeling compliant with Disposición 64/2025

• Instructions for Use

• Technical reports

• Original test reports demonstrating compliance with essential safety and performance requirements (Provision 4306/99 and other applicable regulations)

• Risk management report

Important details

• Validity: Registrations are valid for 5 years before renewal must be requested.

• In-country representation: Foreign manufacturers must appoint a local Authorized Agent in Argentina (AAR). The AAR is a legal entity in Argentina who will assume the registration holder role, manage submissions, and act as a regulatory liaison.

• Translation: All documentation, labeling and IFUs must be in Spanish (or sworn translation) for Argentina.

• Quality management system / GMP: Manufacturers need to demonstrate compliance with ISO 13485 and ANMAT’s GMP requirements; inspections may apply for Class III/IV devices depending on prior authorizations in other markets. Devices approved for sale in the US, Canada, EU, Australia, Japan, and South Korea do not require GMP inspection.

What are the regulatory pathways for medical devices and IVDs in Argentina?

Argentina uses a risk-based system under ANMAT and the RPPMT. Certain Class I devices follow a sworn statement pathway. Other Class I devices and all Class II devices require a Declaration of Conformity. Class III and Class IV devices undergo a full technical review, including evaluation of labeling, testing, GMP evidence, and risk management documentation.

What documentation is required to register a medical device with ANMAT?

Documentation varies by risk classification but typically includes a registration fee receipt, registration form, current GMP certification, and testing declarations. Class II devices must include a risk management report. Class III and IV devices require a full technical file, including labeling per ANMAT specifications, IFUs, technical reports, and original test data demonstrating compliance with essential safety and performance requirements.

What is a Legal Representative in Argentina and why do you need one?

Foreign manufacturers must appoint an Argentina-based Legal Representative, called an Argentina Authorized Representative (AAR), who serves as the registration holder and the official point of contact with ANMAT. This representative is responsible for submitting applications, maintaining the registration, managing updates and variations, and ensuring post-market and vigilance obligations are met. The AAR also acts as your importer of record and manages import logistics.