Passarini Blog
Why should you consider Latin America as a market for your products?
Why should you consider Latin America as a market for your products? Latin America encompasses over 20 countries spread throughout North, Central, and South America, and its predominant language is Spanish, but Portuguese (Brazil) and French are also used. Over the years, Latin America has [...]
RDC 751/2022 comes into force tomorrow, March 1, 2023
RDC 751/2022 comes into force tomorrow, March 1, 2023 RDC 751/2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices, enters into force tomorrow, March 1, 2023. With the publication of RDC 751/2022, several changes [...]
UDI Implementation Deadline for Class I Devices – FDA 510(k) Exempt!
UDI Implementation Deadline for Class I Devices - FDA 510(k) Exempt! We finally reach the UDI (Unique Device Identification) implementation deadline at the Food and Drug Administration (FDA) for class I devices – 510(k) exempt. After the extension given by the FDA in July of [...]
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 [...]
