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, [...]
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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 [...]
Period for payment of FDA annual fee is close! October 1, 2020 opens the deadline for payment of the FY 2021 annual establishment fee. This payment period ends on December 31, 2020. The fee is $ 5,546. You have 90-day window to execute the payment. Get organized. Do not wait [...]
FDA: implementation of the UDI rule The FDA is communicating today through the publication of a new guidance, the second extension of the deadline for compliance with the UDI rule for class I and unclassified devices*, especially because of the COVID-19 pandemic. The Agency believes the policy adopted is consistent [...]
