Tariffs Create Ripple Effects Across Medical Device Regulatory Pathways
Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.
Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.
AdvaMed is advocating for an exemption similar to that granted during President Trump’s first term to mitigate risks to patient care and US medtech innovation.
AAMI released new guidance to update best practices for radiation sterilization validation and routine control of single-use systems.
Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.
The Colorado Association of Biomedical Equipment Technicians (CABMET) has introduced free CBET flashcards and crossword puzzles, available at CABMET’s study resource page. Here, CABMET President Leticia Reynolds shares the inspiration behind these new study tools.
Read MoreAdvaMed and ABHI renewed their MOU to enhance collaboration on AI regulation, trade policy, and regulatory convergence, aiming to improve patient access to advanced medical technologies in the U.S. and U.K. medtech markets.
Read MoreACHC launched two new specialty credentials, the Distinction in Age-Friendly Care and the Distinction in Outcomes, to recognize quality care.
Read MoreAAMI has updated its ethylene oxide (EO) sterilization standard, ANSI/AAMI ST24:2024, addressing new technologies and industry challenges.
Read MoreAAMI TIR48 provides guidance for manufacturers of combination products to comply with FDA CGMP regulations.
Read MoreRalph Basile, a standards corporate executive at Healthmark, has been appointed to a key philanthropic position with the AAMI Foundation.
Read MoreAAMI officially adopted a key international guidance document related to radiation sterilization in medical devices.