The Importance of Quality Systems for the Medical Device Industry In the competitive global medical device market, quality and safety are paramount. Companies in the sector face the challenge of meeting stringent regulations and ensuring compliance with international standards. In this context, the implementation of robust Quality Systems is essential [...]
FDA Increases Fees by up to 21% for Fiscal Year 2025: What You Need to Know. The FDA (Food and Drug Administration) announced on August 1, 2024, the new fees for Fiscal Year 2025 (FY25). Companies that manufacture or distribute medical devices for the US must register annually with the [...]
Anvisa's New Optimized Procedure for Medical Device Registration The National Sanitary Vigilance Agency (Anvisa) has just announced a new optimized procedure for analyzing and deciding on applications for registration of medical devices and in vitro diagnostic devices. The announcement came via Normative Instruction - IN 290/2024, which comes into force [...]
The deadline for UDI to comply with ANVISA is approaching With the publication of RDC (Collegiate Board Resolution) No. 591/2021, ANVISA established the requirement to identify medical devices in its regulated products using the UDI (Unique Device Identification) system. The UDI is the set of codes formed by the DI [...]
Impact Acquisition: Amoveri Group Acquires Help Medical We are pleased to share news that will certainly positively impact our partnership: Amoveri Group has recently concluded the acquisition of Help Medical, a company owned by Passarini Group. This notable transaction not only marks an important moment in our business journey but [...]
New Anvisa Technical Standards: Ensuring the Quality and Safety of Medical Devices On March 8, the National Health Surveillance Agency (Anvisa) announced the publication of the updated list of Technical Standards applicable to the certification of conformity of equipment subject to the Health Surveillance regime. These technical standards represent the [...]
Celebrating 15 Years of Innovation and Excellence with Passarini Group! It is with great enthusiasm that we share with you an extraordinary journey of 15 years of innovation, excellence, and success with Passarini Group! Throughout this trajectory, we have proudly served our friends, clients, and partners, offering specialized solutions in [...]
Anvisa approves Strategic Plan for the 2024-2027 cycle The National Health Surveillance Agency (Anvisa) is the regulatory body responsible for health regulation in Brazil, working to protect and promote the health of the population. To fulfill its mission, Anvisa develops and implements strategic plans that define its objectives, outcomes, and [...]
RDC 830/2023 comes into force from june 1, 2024 RDC 830/2023, provides for the risk classification notification and registration regimes, and labeling requirements and instructions for in vitro diagnosis, including their instruments, comes into force from the 1st of june 2024. With the publication of the RDC 830/2023, several changes [...]
Passarini Europe Solutions: Expanding Horizons to Better Serve Your Business Passarini Group is honored to officially announce the launch of our newest venture: Passarini Europe Solutions! This is an exciting milestone in our journey, which reflects our unwavering commitment to excellence in regulatory advice and our desire to be closer [...]
