Accelerating Market Access in Mexico: Understanding COFEPRIS's New Abridged Regulatory Pathway The regulatory landscape for the entry of medical devices into Mexico has just undergone a significant transformation. On July 18, 2025, the "Acuerdo por el que se emiten los Lineamientos generales para la aplicación de la vía regulatoria abreviada [...]
ANVISA Changes How Certificate Validity is Counted, Providing Clarity for Renewals The Brazilian Health Regulatory Agency (ANVISA) has published a crucial update that directly impacts the industry and regulated sector, bringing more clarity and legal certainty to certification processes. From now on, the way the validity period for Good Manufacturing [...]
ANVISA Publishes RDC 982/2025: Understanding the Optimization of Risk Management and Compliance Monitoring Keeping up with constant regulatory updates is essential for any company in the sector. The Passarini Group highlights the recent publication of ANVISA's Collegiate Board Resolution (RDC) No. 982, from July 28, 2025, which arrives to enhance [...]
Argentina: A Giant Awakens for the Medical Device Sector Argentina, a country that has historically navigated turbulent waters, now displays a promising horizon, flashing a green light for investors and companies, especially in the healthcare sector. After years of instability, the neighboring country shows robust signs of recovery and stability, [...]
Anvisa Opens Public Consultation on UDI: Understand the New Requirements for Medical Devices The Brazilian Health Regulatory Agency (Anvisa) has announced the opening of a public consultation to gather contributions regarding the requirements for the transmission and management of the Brazilian Unique Device Identification (UDI) database for medical devices. The [...]
Do you know how the INMETRO Seal is Applied? The INMETRO Seal is something you've certainly seen on many products in your daily life. But do you know how it works and why it's so important? In this text, we'll explain how this seal is applied and how it helps [...]
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 products reaching Brazilian consumers, and [...]
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 is costly, consider the potential [...]
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 [...]
