Regulatory approach. Past, Present, and Future of the Regulation of Medical Devices in Argentina.

Authors

  • Emilce Vicentin Programa de Evaluación de Tecnologías Sanitarias, Administración Nacional de Medicamentos, alimentos y tecnología Médica (ANMAT), Ciudad Autónoma de Buenos Aires, Argentina.
  • Carolina Magnatti Instituto Nacional de Productos Médico, Administración Nacional de Medicamentos, alimentos y tecnología Médica (ANMAT), Ciudad Autónoma de Buenos Aires, Argentina.

Abstract

Medical devices are mostly used in healthcare environments to save lives, improve health and life quality. They could be intended to contraception, prevention, diagnosis, treatment, illnesses, and disabilities rehabilitation. The definitions adopted at local, regional and global levels may vary on the base of the focus given by the Regulatory Government Agency; these are usually complemented by other definitions such as intended purpose, accessory, product's family, etc. These products belong to a mixed category, made of simple and low-risk products as syringes, bandages and stethoscopes, and complex products, for instance, implantable and life support devices, image diagnosis equipment. If we make a pause to observe the life cycle of technologies (development, adoption, broadcasting, obsolescence) we will recognize that it is getting faster. The premature substitution of the current technologies to the most innovative ones is due to: the intensive use and the fast diffusion, demanded by patients and health professionals; and accessibility to markets where high complexity technologies are produced (importation), which immediate access can lead to high costs and accessibility impediments to health systems, bad practice, overdiagnosis and unnecessary treatment, among others. Regulatory agencies normally develop technical standards, in some cases regionally or internationally harmonized, where it is established the requirements that must be complied to be authorized to market medical products in certain territory. This work’s purpose is to expose the evolution of the regulatory context, including past, present and immediate future state, carried out to check and control medical devices before their commercialization, so that authorized products do not put the Argentinian population on risk.

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Published

06/01/2022

Issue

Section

Scientific articles