Medical supplies regulations in Brazil

• Autor(a) principal: Feitoza-Silva, Michele
• Data de Publicação: 2017
• Outros Autores: Nobre, Patrícia Fernandes da Silva, Gemal, André Luis, Leandro, Katia Christina
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Revista de Direito Sanitário (Online)
• Texto Completo: https://www.revistas.usp.br/rdisan/article/view/142019
• topic: Brazilian Health Regulatory Agency; Legislation; Medical Supplies; Regulations.; Agência Nacional de Vigilância Sanitária; Legislação; Materiais Médicos; Regulação.

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.