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 the holder is the Regulatory [...]
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 new legislation will get into [...]
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 Agency’s services fully digital. Solicita [...]
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 2013. ANVISA published in the [...]
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 No. 657, OF MARCH 24, [...]
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 [...]
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 company in Brazil to offer [...]
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. [...]
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 labeling. The Resolution will be [...]
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 responsible for imputing and updating [...]
