Passarini Blog
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 [...]
Resolution of the Directive Board (RDC) 432, ANVISA
Resolution of the Directive Board (RDC) 432, November 4th, 2020 - ANVISA ANVISA has published the Resolution of the Directive Board - RDC nº432 to establish the obligation of describing the composition of personal hygiene products, cosmetics, and perfumes in the Portuguese language on the [...]
Resolution of the Directive Board (RDC) 431, ANVISA
Resolution of the Directive Board (RDC) 431, October 31st, 2020 - ANVISA ANVISA has published the Resolution of the Directive Board RDC 431/2020 where establishes the loading of instruction for use on the ANVISA website. The loading is MANDATORY and the holder of the product is [...]
