Passarini Blog
RDC 751/2022: Risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use for medical devices
RDC 751/2022: Risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use for medical devices. Resolution - RDC no. 751, of september 15, 2022 was published yesterday (21/09) in the official Gazette of the Union, which provides for risk [...]
Anvisa updates rules for the regularization of medical devices in Brazil
Anvisa updates rules for RDC nº 185/2001 - regulation of medical devices in Brazil Anvisa released on its website on Wednesday (14/09) a news informing about the update of the rules for regularization of medical devices in Brazil. According to Anvisa, the Collegiate Board approved the [...]
Anvisa now requires digital signatures in medical device processes and petitions
Anvisa now requires digital signatures in medical device processes and petitions The National Health Surveillance Agency – ANVISA circulated this week through Solicita System the Circular Letter No. 1/2022/SEI/GGTPS/DIRE3/ANVISA, which mainly provides with guidelines for signatures in process and petition documents for medical devices. In [...]
PassRod has joined ABIMED
PASSARINI GROUP is pleased to inform that PASSROD, one of the group's companies, has joined ABIMED Associação Brasileira da Indústria de Tecnologia para Saúde, entidade que aproxima indústria e governo, colaborando com a construção de políticas públicas voltadas ao setor, sendo também protagonista na criação [...]
Do you know the benefits of Passarini Group Hosting Service?
Do you know the benefits of Passarini Group Hosting Service? We will show you some triggers that can help you be more assertive in your business. But what is Hosting Service anyway? It is the hosting service for the registration of an imported product, where [...]
ANVISA – RDC No. 687 GMP
ANVISA - RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices Published on May 13th: RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices. The [...]
