25: Clinical Microbiology In Vitro Diagnostic Medical Devices in Argentina

CHAPTER 25
Clinical Microbiology In Vitro Diagnostic Medical Devices in Argentina: Regulatory Requirements and Product Information


Marcela Echavarria1 and Mariela Aranda2


1 Center for Medical Education and Clinical Investigations, Buenos Aires, Argentina


2 National Administration of Drugs, Foods and Medical Devices, Buenos Aires, Argentina


25.1 History


Medical devices, drugs and food are a matter of serious concern due to their close connection with the health of the population. In Argentina, the production and commercialization of all products used in human medicine have been regulated by the National Medicines Act 16463/64 [1] since 1964. The Instituto Nacional de Normatización de Drogas y Medicamentos, later known as Instituto Nacional de Farmacología y Bromatología (INFyB), also started in 1964.


Clinical microbiology is a very dynamic field with frequent changes. Therefore, it must be regulated and supervised by a health authority that guarantees that rules and procedures will be duly met. Thereby, medical devices, drugs and food available to the population will meet the international standards of quality, efficacy, and safety.


The regulation of new drugs and medical devices for their commercialization in Argentina has been modified over the years. In 1992, the Medicines Act was amended, which required the creation of a specific agency with technical and administrative capacities to guarantee that the amended act would be in force. Thus, the National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) was established [2].


25.1.1 ANMAT: development and objectives


ANMAT was started as a health agency with a regulatory mission (Law Decree 1490/92) [3], which was defined as follows:



  • To authorize and register the manufacture and marketing of medicinal, diagnostic and cosmetic products, as well as their updates and modifications.
  • To monitor the premises engaged in the manufacture, import, fractionation and/or marketing of the above-mentioned products, in addition to setting the regulations and technical specifications they must comply with.
  • To control the composition, quality, efficacy, and harmlessness of the above-mentioned products.
  • To authorize, register, control, and monitor the quality and healthiness of foodstuff including dietary supplements and any material in contact with foodstuff. All this is carried out as a joint task together with the federal health jurisdictions.
  • To participate in the creation and update of regulations.
  • To authorize medical devices as well as the materials and equipment to be used in human medicine. To formulate and enforce regulations assuring the quality of medical devices manufacture, import, and storage processes.
  • To watch for undesired effects, inefficiency, and quality failure of the products it regulates. For this purpose, information networks were developed to gather any notifications made by professionals, institutions, or users by means of the Pharmacovigilance, Technovigilance and Food Vigilance National Systems.
  • To communicate and disseminate any health-related significant information among professionals and public in general, through periodical and nonperiodical publications.
  • To promote the “Good Practices for Clinical Pharmacology Studies” in any clinical investigation on new drugs in compliance with international ethics regulations and with a specific inspection program.
  • To authorize the advertising of over-the-counter drugs, dietary supplements, and the medical devices facilitating their consumption and use, as well as guiding consumers in doing so.

With the support of qualified professionals and technicians, ANMAT can achieve the aforementioned objectives.


The following entities depend on the ANMAT organization:



  • INAME (Instituto Nacional de Medicamentos) National Institute of Drugs: supervises those entities engaged in the production, import, or commercialization of drugs and cosmetic products. This institute further controls the related activities, processes, and technologies to provide certified quality products.
  • INAL (Instituto Nacional de Alimentos) National Institute of Food: this entity is engaged in the registration and control of food, goods used for food production, household products, and materials coming in contact with food. These tasks require an interaction with the provinces, and technical assistance to address health supervision.
  • National Directorate Of Medical Devices (Dirección Nacional de Productos Médicos): this division supervises the quality of medical devices as well as the activities, processes, and technologies performed for their manufacture, fractionation, import, export, and storage.

25.1.2 ANMAT: Reference Regional Drug Regulatory Authority


As a World Health Organization (WHO) initiative to promote the accreditation of drug regulation national authorities, ANMAT was evaluated by the Pan American Health Organization (PAHO). PAHO fosters this WHO initiative in America through examination processes carried out by experts in those countries willing to participate. After comprehensive consultation and approval procedures, all of the American countries agreed on the implementation of an assessment tool to analyze both the regulatory requirements the national authority must meet, and the indicators evidencing the authority compliance. In December 2009 ANMAT was the first Regional Regulatory Authority to obtain the highest qualification (Level IV) by PAHO/WHO.


The audit focused on ten modules containing the standards set by PAHO:



  1. National Regulatory Agency (NRA): its organization and legal foundations.
  2. National Regulatory System: organizational structure, institutional development, and quality management.
  3. Marketing Authorization: outlines, guidelines, procedures, evaluation mechanisms, registers, and information availability.
  4. Market vigilance: import and export controls, recall procedures.
  5. Pharmacovigilance: outlines and guidelines, organization and structure, and evaluation procedures.
  6. Regulatory oversight of clinical trials: guidelines, ethical framework, organization and structure, evaluation procedures.
  7. Licensing of manufacturers, importers, and retailers
  8. Regulating inspections and monitoring activities: guidelines, outlines, planning, and registry.
  9. National quality control laboratory: organization, structure, quality management, human resources, equipment, and safety structure.
  10. NRA Lot Release.

This evaluation process and resulting recognition of ANMAT as a PAHO Reference Drug Regulatory Authority was a powerful incentive for the whole agency. In light of the above mentioned, the professional, technical, and administrative staff are deeply committed to the objective in the knowledge that the achievement of this result would mean a significant improvement and advancement in the area of diagnostic medical devices. The working teams displayed an excellent technical and professional performance, which was reflected in the final qualification obtained.


In 2011, at the VI Pan American Conference on Drug Regulatory Harmonization (CPANDRH) [4] organized by the Pan American Network for Drug Regulatory Harmonization (PANDRH) [5] in the city of Brasilia, ANMAT was acknowledged by PAHO as a Reference Regional Drug Regulatory Authority for a 3-year period.


25.1.3 MERCOSUR


In 1991, the Treaty of Asunción was signed between Argentina, Brazil, Paraguay, and Uruguay to establish the Southern Common Market (MERCOSUR) [6]. Later, Bolivia (1997) and Venezuela (2004) joined as associate countries. The MERCOSUR ministers of health have worked hard on the process of harmonizing several topics, such as health in border areas, environment, drugs policy, the Millennium Development Goals, disasters, primary health care, epidemiological surveillance (e.g., malaria and dengue), sexual and reproductive health, HIV/AIDS, and review of the International Sanitary Code. Since 1995, MERCOSUR Ministers of Health have met annually.


A special working group (Working Subgroup No. 11/ Health – SGT N°11) is also entirely engaged in health issues and is focused on the following: harmonization of laws and directives; technical cooperation; actions taken among the parties in the fields of health care, goods, services, raw material, health products, professional practice, epidemiological surveillance and sanitary control. The aim is to promote and protect health and life, overcome the obstacles related to regional commerce, and foster overall health care [7].


Argentina guarantees that the laws issued by MERCOSUR bodies shall be fulfilled. Thus, Argentina incorporates the MERCOSUR Provisions into its national legislation.


25.2 Regulation of clinical microbiology in vitro diagnostic medical devices in Argentina


In Argentina, the regulation of reagents, diagnostic products, and any other product for human medicine started in 1964. With the advent of globalization emerged the need to adapt and update the regulatory system. Thus, since 1994 the registration of all entities engaged in the manufacture, import, export, or sale of in vitro diagnostic (IVD) medical devices became mandatory. In addition, all products commercialized in Argentina should be previously registered. The ANMAT Resolution N° 2674/99 has the requirements for IVD registration [8]. As a result of the technical advances in IVD, the regulations concerning registration of these products have been amended.


Regulations about inspections of companies engaged in IVD manufacture or import were also passed pursuant to ANMAT Resolution N° 3266/13 [9]. Regulations concerning the qualification of entities engaged in these activities [10] and requirements about IVD distribution and commercialization (ANMAT Resolution N° 6052/913) were also passed. Recommendations on Good Manufacturing and Control Practices, and Inspections Guidelines for IVD manufacturers, importers, and exporters were harmonized with the MERCOSUR group.


The reagents to be used in molecular biology techniques are regulated under Decree N° 3619/97. These products are antibodies, specific receptor proteins, ligands, nucleic acid sequences, and other similar molecular biology products or reagents. According to this regulation, companies must submit a form and catalogs of those reagents to be commercialized. In addition, those companies that manufacture or sell these products must be licensed by ANMAT.


25.2.1 IVD definition


The IVD medical devices are those reagents, instruments, and systems that allow performing a qualitative, quantitative, or semiquantitative determination in specimens obtained from a human body. Therefore, an IVD should not be ingested, injected, or given to humans. They have been designed and developed to assess health or disease, supervise treatments, detect or follow a medical condition, diagnose, prevent, carry out blood donor screening, and determine the safety and compatibility with potential recipients. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other devices. The international reference materials (e.g., WHO) and materials used for external quality assessment schemes are excluded.


Specimen containers are considered to be IVD medical devices. These receptacles, whether vacuum-type or not, are specifically made for the containment and preservation of specimens derived from the human body for IVD examination purposes.

Dec 10, 2017 | Posted by in MICROBIOLOGY | Comments Off on 25: Clinical Microbiology In Vitro Diagnostic Medical Devices in Argentina
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