Medical supplies regulations in Brazil
DOI:
https://doi.org/10.11606/issn.2316-9044.v18i2p122-156Keywords:
Brazilian Health Regulatory Agency, Legislation, Medical Supplies, Regulations.Abstract
Products under health surveillance classified as "products for health" comprehend the "medical supplies". Regulatory acts issued from 1999 to 2005 were selected and classified by subject enabling the discussion of these publications’ profiles. The classification was made by evaluating each legislation, its agenda and the text published in the Diário Oficial da União, the government’s official gazette in Brazil. To help the discussion we proposed a classification in eight subjects (themes). In this way, it was possible to correlate and demonstrate the prevalence of published subjects indicating a tendency of the themes contemplated in every year of the period under evaluation. As a reflection, we believe that in this case, there is a unique oportunity for the Brazilian Health Regulatory Agency taking action due to its organized normative framework, with applicability to fields like registration, good practices, issues related to companies in the health business and post-marketing. However, these legislation will only be applicable and efficient if there is up-to-date knowledge among the health care professionals about general health surveillance standards that support more efficient management decision-making processes, without jeopardizing the safety of the population.
Downloads
Downloads
Published
Issue
Section
License
The Revista de Direito Sanitário/ Journal of Health Law adopts the conditions of the Creative Commons Attribution 4.0 Internacional. This license allows to share - "copy and redistribute the material in any medium or format for any purpose, even commercially" and adapt - "remix, transform, and build upon the material for any purpose, even commercially." Details at: https://creativecommons.org/licenses/by/4.0/deed.en