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 [...]
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, [...]
