Passarini Blog
ANVISA: A Complete Guide to Product Regulation in Brazil
Navigating the World of ANVISA with Passarini Group You might think dealing with ANVISA is a Herculean task, an insurmountable mountain of bureaucracy that drains your company's time and resources. But the truth is that ANVISA, as a health protection agency, ensures the safety of [...]
CE Marking as Your Passport to Success
Conquer the European Market with Passarini Group: CE Marking as Your Passport to Success The European market presents a promising opportunity for Brazilian companies seeking to expand their business, especially in the innovative medical products sector. While you may think that investing in CE certification [...]
The Importance of Quality Systems for the Medical Device Industry
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 [...]
Understand the impact of the FDA fee adjustment on your business
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 [...]
Anvisa’s New Optimized Procedure for Medical Device Registration
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 [...]
UDI: How to Prepare for ANVISA’s Regulatory Changes in Medical Devices
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 [...]
