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 (DI = Device Identifier) and [...]
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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 ISO 13485 Medical Devices Standard. [...]
FIME 2018 Passarini Regulatory Affairs confirms presence of its consultants at FIME 2018 - medical fair in Orlando - USA. July 17-19, 2018 Location: Orange County Convention Center, Orlando - Florida Schedule a meeting by email: [email protected] Learn more about the event: https://www.fimeshow.com/en/home.html Keep up with our social networks: [...]
Hospitalar Fair 2017 Passarini Regulatory Affairs will be, for the first time, with a stand at the Hospitalar Fair to attend companies and talk with clients. May 16-19, 2017 Expo Center North Rua José Bernardo Pinto, 333 - Vila Guilherme - São Paulo / SP Visit our stand - [...]
News in CE Process It was published today, May 5, 2017, the new Directive that regulates the medical devices replacing the Directive 93/42 / EEC EC. Click here to access in full the original text of the New Directive for CE mark. Do you have any doubts? Contact us by e-mail: [...]