Medical Device Regulations and Registration Process in Argentina, ANMAT

Medical device market in Argentina is estimated to reach $6.16 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of approximately 6% by 2026, one of the largest medical device markets in Latin America.
Argentina is an import-driven market with a significant portion of medical devices imported from the USA, Germany, China, and Brazil.
Current market challenges are the economic factors such as inflation, currency devaluation, and economic instability that have a significant impact on ‘the accessibility of medical devices for healthcare providers and patients’ and ‘financial viability of the medical device companies.’

This article covers Medical Device Regulations for registration with Argentina ANMAT.

The National Administration of Drugs, Food and Medical Devices is a decentralized body under the Ministry of Health responsible for overseeing the registration and regulation of medical devices in Argentina. ANMAT in Spanish stands for ‘Argentine Administración Nacional de Medicamentos, Alimentos y Tecnología Médica’.

Classification of Medical Devices in Argentina

Argentina follows the Global Harmonization Task Force (GHTF) guidelines for medical device registration in the medical devices classification system and is divided into class I, II, III, and IV depending on the associated risk. The classification system is as follows:

Class I: Low-risk devices, such as non-invasive instruments and bandages.
Class II: Medium-risk devices, including contact lenses and electrocardiographs.
Class III: Higher-risk devices, such as implantable devices and X-ray equipment.
Class IV: The highest-risk devices, including active implantable devices and life-supporting equipment.

The rules for the classification of medical devices in Argentina are the same as in the European Union (EU) except that the class II, class III and class IV of Argentina represent the EU class IIa, class IIb and class III respectively.

In vitro diagnostic devices are considered a separate group in Argentina and follow a classification system based on the GHTF guideline document ‘Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices.’

ClassRisk associatedExamplesClass ALow Individual Risk and Low Public Health RiskClinical Chemistry Analyser, general culture mediaClass BModerate Individual Risk and/or Low Public Health RiskVitamin B12, Pregnancy self-testing, Anti-Nuclear Antibody, Urine test stripsClass CHigh Individual Risk and/or Moderate Public Health RiskC Blood glucose self-testing, HLA typing, PSA screening, RubellaClass DHigh Individual Risk and High Public Health RiskHIV Blood donor screening, HIV Blood diagnostic

Labeling Requirements in Argentina:

The labeling of medical devices may vary depending on the class of the device including IVD devices. Some of the key requirements are:

For Class I Medical Devices,

Device Identification: The device must include the device name, model, or catalogue number, and the name and address of the manufacturer or authorized representative. Argentina recognizes the Emergency Care Research Institute (ECRI) nomenclature called the Universal Medical Device Nomenclature System (UMDNS) for easy identification of the device.
Intended Use: intended use or purpose of the device must be specified.
Instructions for Use: Clear instructions for the proper use, handling, storage, and maintenance of the device must be provided.
Contraindications and Warnings: Any contraindications, warnings, precautions, or limitations associated with the use of the device shall be mentioned.
Language: The labeling should be in Spanish.

For Class IIa, IIb, and III medical devices, additional requirements include enclosing information such as:

Technical Specifications: Provide relevant technical specifications, such as device dimensions, weight, power requirements, and any specific operating parameters.
Symbols and Icons: Use internationally recognized symbols such as CE marking, electrical safety, or sterilization status.
Sterilization Information: Instructions or information regarding the appropriate sterilization method and conditions, if applicable to the device.
Clinical Data: For Class III and IV devices, the labeling may need to include information related to clinical data supporting the safety and performance of the device.

Pre-Registration Requirements

Clinical trials requirements:

As per the MoH Regulation No. 1,480/2011 and ANMAT Regulation No. 6,777/2010, clinical trials protocol must be approved by ANMAT and by the intervening Ethics Committee.

Ethics Committee Approval: Before conducting a clinical trial, researchers must obtain approval from an accredited Ethics Committee in Argentina. The Ethics Committee is responsible for reviewing the trial protocol, and informed consent forms, and ensuring adherence of the study to ethical guidelines.
Good Clinical Practice (GCP): Clinical trials in Argentina must adhere to international standards of Good Clinical Practice, which ensure the ethical conduct of the trial, data integrity, and participant protection.
Pharmacovigilance Reporting: Any adverse events shall be promptly reported to ANMAT as part of the pharmacovigilance obligations.

Testing requirements:

Medical devices and in vitro diagnostics (IVDs) undergo testing to assess their safety, performance, and compliance with regulatory standards. The specific testing requirements may vary depending on the classification and intended use of the device.

Safety and Performance Testing: While safety testing aims to evaluate the potential risk associated with the medical device, performance testing evaluates the accuracy and reliability of the device’s functionality.
Quality Management System: Manufacturers of medical devices and IVDs are typically required to implement a certified quality management system, such as ISO 13485. The Good Manufacturing Practices certification demonstrates compliance with quality standards in the manufacturing process. Medical devices manufactured in or imported to Argentina must show conformity with Mercosur Technical Regulations for Registration of Medical Products according to provision 3802/2004.
Sterility and Microbiological Testing: For certain devices, sterility testing is essential to ensure they are free from harmful microorganisms. Examples: devices that come in contact with body fluids.
Analytical and Validation Testing: IVDs undergo analytical testing to validate their accuracy and reliability in detecting specific analytes or markers. This may involve testing with known samples and comparison to established reference methods.

Steps involved in the medical device registration as per Argentina ANMAT regulations

Step 1: Argentine Local Authorized Representative

Manufacturers outside Argentina who wish to register their medical devices in Argentina must appoint a local authorized representative. The representative acts as a liaison between the manufacturer and the regulatory authority.

Step 2: Technical Documentation

The manufacturer or its authorized representative must compile and submit the necessary technical documentation for the medical device registrations with Argentina ANMAT. This documentation includes information such as device description, intended use, design specifications, manufacturing process, labeling, and instructions for use.

Step 3: Submission of Application

The application for registration, along with all the required documentation, should be submitted for medical device registration with Argentina ANMAT. The application should include details about the manufacturer, the device, its intended use, and any supporting files such as clinical results, performance, and safety reports.

Timelines for registration process: The complete registration and approval process typically takes about 12-15 months. The application review process along with technical documents for class I and II devices take about 15 to 30 working days while class III and IV takes about 60 to 120 days.

The registration fee is subject to change and is generally decided by ANMAT depending on the classification and complexity of the device.

Class of medical device

Approx. registration fee for medical devices registration in Argentina ANMAT

Class I 155 USD

Class II195 USD

Class III 260 USD

Class IV 360 USD,

IVD A and B 140 USD

IVD C and D 175 USD

Step 4: Certificate of Registration

Upon successful completion of the evaluation, a certificate of registration is issued for the medical device registration by Argentina ANMAT valid for a period of 5 years.

The EU/US-approved medical device in Argentina

If the medical device is already approved by the EU/US, it qualifies for an expedited medical device registration process for approval in Argentina ANMAT, since the registration process is simplified.

Regulatory Convergence: Like many other countries, Argentina recognizes the regulatory standards and certifications from well-established regulatory authorities such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). The approval by EMA or the FDA signifies that the medical device meets stringent regulatory requirements and is held credible during the registration process.
Reference to Existing Documentation: ANMAT (the regulatory authority in Argentina) accepts the documentation and data from the EU or US regulatory submissions as a reference in most cases. As a result, the registration process will be streamlined, as the extensive technical documentation and clinical data already available can be used to support the safety and efficacy claims of the device.
Expedited Review: Approval from EU or US regulatory authorities can expedite the review process in Argentina. ANMAT considers the assessments and evaluations conducted by these reputable regulatory bodies, which can lead to a faster review and approval process.

Product Importing Requirements:

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

Distribution Requirements:

Good Distribution Practices (GDP): Distributors of medical devices in Argentina must adhere to Good Distribution Practices, which ensure the proper storage, handling, and distribution of the devices across the supply chain. This includes maintaining appropriate storage conditions, tracking the product's chain of custody, and implementing quality management systems.

Distribution Agreements: Importers and distributors need to establish distribution agreements with manufacturers outlining the rights, responsibilities, and obligations of both parties and ensure compliance with applicable regulations in Argentina ANMAT.

Post Marketing Surveillance

Pharmacovigilance system: Manufacturers and distributors of medical devices are required to monitor the safety and performance of their devices periodically after they have been approved for marketing in Argentina ANMAT. Any adverse event such as unintended or harmful effects resulting from the use of a medical device, including malfunctions, serious injuries, or deaths shall be promptly reported to ANMAT. Manufacturers are required to submit Periodic Safety Update Reports (PSURs) compiling all information pertaining to the safety profile of the medical device based on the analysis of collected adverse event data, clinical data, and other relevant safety information.
Signal Detection and Risk Management: Manufacturers should actively monitor and analyze safety data to detect potential safety signals and emerging risks associated with their medical devices. This includes conducting regular safety data analysis and implementing risk management measures to mitigate identified risks.
Renewal: Initially, the license is issued for a period of 5 years and revalidation of the device should be performed within the given time frame, preferably within 30 days from the date of expiry. A revalidation request shall be submitted to the ANMAT. After a thorough review process, the license shall be reissued. Additionally, the manufacturer or representative who wishes to transfer or cancel the registration request shall do so by submitting an appropriate request.
Audits and Inspections: In order to ensure that the product is compliant with regulatory requirements and meets quality standards, ANMAT conducts audits and inspections. The Audit process shall also assess the quality management system of the manufacturers and distributors. These audits can be scheduled or performed as part of routine inspections. During an audit, ANMAT may review documentation, assess manufacturing practices, and evaluate compliance with regulations and guidelines.

For more details on the regulatory process, get in touch with Artixio, a globally trusted consultant for regulatory assistance.

References:

https://www.argentina.gob.ar/anmat/anmat-en/what-anmat