EUDAMED Is Now Mandatory: What Changes for Medical Device Manufacturers and Importers? Published by Passarini Group | Regulatory Affairs & International Market As of May 28, 2026, the European medical device sector has undergone a significant structural transformation: four modules of EUDAMED—the European Database on Medical Devices—have become mandatory across [...]
SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines The medical device sector in Brazil has just taken a historic step towards total traceability. During the 2nd Ordinary Public Meeting of the Collegiate Board (DICOL) in 2026, Anvisa approved the Normative Instruction that establishes the rules [...]
FDA Publishes New Quality Management System Regulation (QMSR) and Transforms the Regulatory Landscape for Medical Devices The U.S. Food and Drug Administration (FDA) has published the Quality Management System Regulation (QMSR), a significant update to the former Quality System Regulation (QSR) found in 21 CFR Part 820. This new regulation [...]
The Myth of the "Easy" Process In the medical device sector, there is a common and mistaken perception that the regulatory process for Class I and II products is simple and quick. Many companies have the false impression that "it seems easy, but it's not!". This simplistic view hides an [...]
New ANVISA Scheduling System: 3 Compliance Rules You Need to Master (And the 5-Year Record Keeping Risk) The end of the Parlatório and ANVISA's new digital era: Understand how Ordinance 54/2021 and automation demand Compliance 4.0 to avoid rejections and ensure the legal security of your business. The National Health [...]
The End of Waiting: ANVISA Automates AFE and AE, Transforming Brazil’s Regulatory Routine The Authorization to Operate (AFE) and Special Authorization (AE) are foundational documents for any company seeking to operate in a market regulated by the Brazilian Health Regulatory Agency (ANVISA), covering sectors such as pharmaceuticals, medical devices, cosmetics, [...]
The “Tarifaço” and the Changing Export Routes of Brazilian Medical Devices The term “tarifaço” refers to the steep tariffs imposed by the United States on certain imported products — in this case, Brazilian medical devices — which increase the cost of direct access to the U.S. market. As a result, [...]
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 out direct imports, ensuring greater [...]
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 [...]
