Article 3 distributors and storage agents of medical devices and in vitro diagnostic devices shall meet the requirements of this resolution, as applicable. Rdc 4499anvisa boas praticas em farmacias e drogarias by. Antes da revalidacao, a adequacao dos registros as disposicoes do regulamento tecnico implica em um novo registro. Brazil medical device regulations anvisa guidelines emergo. We also can help you register your medical devices with anvisa. Comprehensive list of medical device regulations for medical devices sold in brazil. Os procedimentos operacionais padrao pops devem ser discutidos com a equipe, aprovados, assinados e datados pelo farmaceutico responsavel tecnico. Anvisa will only approve device registrations after successful completion of a bgmp audit. Anexo iii, com seus respectivos apendices i e ii da resolucao n. Brazil gmp bgmp quality system consulting rdc 59, rdc. Anvisa may undertake a control analysis of commercialized batches in official laboratories in order to monitor the quality and conformity of the drug with the drug registered. Legislacao em vigilancia sanitaria resolucao rdc n.
Brazil medical device regulations anvisa guidelines. Pdf regulatory affairs in brazil avoid losing time and. Regulatory affairs in brazil avoid losing time and money registering products with anvisa in brazil. Classification and registration requirements of medical products, en pt, rdc 1852001, 2001.
Jan 28, 2014 anvisa may undertake a control analysis of commercialized batches in official laboratories in order to monitor the quality and conformity of the drug with the drug registered. Em seu lugar foi publicada tambem no dia 2803 a rdc 1620. Bgmp inspection requests for foreign manufacturers must be submitted by your brazil registration holder brh, who will then be the owner of the certificate issued by anvisa. Whenever necessary, anvisa may request that the companies train their technicians in order to enable them to undertake this monitoring. The requirements for medical devices are specified in brazilian resolution rdc 1620 and are similar to fda quality system regulation 21 cfr part 820 and iso 485 requirements, with some notable differences.