Passarini Blog
ANVISA – SOLICITA SYSTEM
ANVISA - Solicita System For submission of documents for petitioning processes at the National Health Surveillance Agency – ANVISA, there are currently two systems: ELECTRONIC PETITION and SOLICITA SYSTEM. The Solicita System was developed internally by ANVISA to make the demands of users to the [...]
ANVISA – RDC Nº 665, GMP for Medical Products and In Vitro Diagnostic Products
ANVISA - Published on March 30th: RDC No. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products. The new RDC will come into force on May 2nd, 2022. The new RDC 665/2022 revoked RDC 16/2013 and incorporated IN 8 of [...]
ANVISA – RDC Nº 657, Regularization of software as a medical device
ANVISA - COLLEGIATE BOARD RESOLUTION - RDC Nº 657, OF MARCH 24, 2022: Provides for the regularization of software as a medical device (Software as a Medical Device – SaMD) ANVISA published in the Official Gazette, on March 30, 2022, the COLLEGIATE BOARD RESOLUTION - RDC [...]
UDI for Brazil – ANVISA
UDI for Brazil - ANVISA Published on December 29th, 2021, and effective as of January 10, 2022, ANVISA informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil. The UDI is composed of the UDI-DI [...]
We are ONE STOP SHOP!
We are ONE STOP SHOP! A term used very much by companies that can concentrate all the solutions sought by their customers in one place, without outsourcing or the need to involve other companies in the delivery of its services. We are the only regulatory [...]
Anvisa Quality System Management
ANVISA Quality System Management Implementation and Maintenance If you export medical devices to Brazil, getting ANVISA registration is the first step to making them viable in the market. ANVISA requires you to ensure that all your manufacturing locations meet Brazilian Good Manufacturing Practices (GMP) requirements, the local equivalent of the [...]
