A New Approach to Classification and Registration of Medical Devices in Mozambique

• Autor(a) principal: Ribeiro, Helena
• Data de Publicação: 2022
• Outros Autores: Mabunda, Lígia, Freitas, Sílvia, Sitoe, Ana Raquel, Bettencourt, Ana
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: https://doi.org/10.25756/rpf.v13i3.278

The National Medicines Regulatory Authority, I.P (ANARME, I.P) of Mozambique created several mechanisms to ensure the quality, safety and performance of medical devices (MDs) with the publication of the Ministerial Dispatch of January 13th, 2017. However, one of the main shortcomings of the current regulatory system is the fact that it does not cover the entire classification and registration system, in order to allow clear rules for stakeholders.In this article, it is intended to propose harmonized guidelines, which can control the life cycle of MDs, from their classification and conformity assessment through a simplified registration process, in order to assure users (patients and healthcare professionals) safe health products and the authority for effective surveillance of MDs. The procedures described refer specifically to the classification and registration processes of MDs, in order to reduce time to market and the costs involved, adapt the regulatory processes to the type of MD, facilitate trade and expand access market, without neglecting the quality and performance of the MDs.