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CNSIAM CONAMPrefeitura Municipal de TaubateAV. TIRADENTES, 00520 CENTROC.N.P.J. 45.176.005/000108 I.E. ISENTOLicitacao PREGAO numero 00005 /2015 PG. 1Proposta Comercial Anexo IRAZAO SOCIAL DA
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The Manual de Tecnovigilância UMA is a document outlining the regulations and procedures for monitoring and ensuring the safety and effectiveness of medical devices and health technologies.
Manufacturers, distributors, and healthcare facilities that handle medical devices and health technologies are required to file the Manual de Tecnovigilância UMA.
To fill out the Manual de Tecnovigilância UMA, one must follow the specified guidelines provided by the regulatory authority, ensuring that all necessary data regarding device monitoring, incidents, and outcomes are accurately recorded.
The purpose of the Manual de Tecnovigilância UMA is to ensure the continued safety, effectiveness, and quality of medical devices and to establish protocols for reporting adverse events.
Information that must be reported includes device identification, incidents of adverse effects, corrective actions taken, and follow-up evaluations regarding device safety.
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