Passarini Blog
Devices to America: How U.S. Tariffs Are Changing Medical Device Exports
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 [...]
DDR and DUIMP: How ANVISA’s Import Rules Stand
ANVISA Confirms Continuity of Direct Imports via DDR ANVISA has recently published the new Import Manual, confirming that the Declaration of the Registration Holder (DDR) will remain valid. This document allows the holder of a product registered in Brazil to authorize third parties to carry [...]
Agility and Efficiency: How COFEPRIS’ Fast-Track Path Speeds Up Medical Device Registration in Mexico
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 [...]
ANVISA Sets New Rule for Good Practice Certificate Validity
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 [...]
RDC 982/2025: What’s Changing for the Good Practice Certificate?
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, [...]
Argentina’s Economic Revolution and the Medical Device Boom
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 [...]
