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 [...]
Location of Articles, Challenges, and Requirements In the quest for useful articles in clinical evaluation, frequent challenges arise. Our podcast delves into this universe to help answer important questions: where to find these articles and how to determine if they are truly valuable? In each episode, we address the reasons [...]
Unraveling Equivalence in Clinical Evaluation: Exploring the 2nd Episode of the Passarini Group Podcast We are thrilled to present the second episode of our podcast series in partnership with GRINN, focusing on a crucial theme: "EQUIVALENCE IN CLINICAL EVALUATION PROCESSES." In this episode, we delve into the complexities of product [...]
Unveiling Clinical Assessment: The New GRINN Podcast in Partnership with Passarini Group We are excited to share some news with you! In collaboration and with the full support of Passarini Group, GRINN carried out an extensive survey of frequently asked questions related to clinical assessment. The number of doubts and [...]
Certification of Approval for PPE: The Cornerstone of Workplace Safety Nowdays, one of the most recurring and crucial terms in discussions about workplace safety is PPE, or Personal Protective Equipment. PPE plays a fundamental role in protecting professionals during their work activities, minimizing risks and threats to their health and [...]
Anvisa's Innovation Policy: What It Is and How It Can Impact the Healthcare Sector in Brazil. Innovation in health is an increasingly relevant topic for the development of the sector and the improvement of the population's quality of life. Therefore, it is important to be aware of initiatives aimed at [...]
The Future of Importation: The Impact of ANVISA's New Resolution on the Medical Devices Sector. ANVISA has recently published a new resolution that alters the rules for importing medical devices, including their accessories, into Brazil. This resolution, RDC No. 810/2023, aims to facilitate access for healthcare professionals and patients to [...]
FDA Announces Annual Fee Adjustment for Medical Devices. The FDA (Food and Drug Administration) announced the new fees for Fiscal Year 2024 (FY24) in the last week, on August 9th, 2023. Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use [...]
