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AdvaMed, the medtech association, working alongside the Department of Commerce’s International Trade Administration, advocated for and secured the recently implemented transition extensions for certifying medical devices in the European Union…
AdvaMed was privileged to host a delegation from Korea’s Ministry of Food and Drug Safety (MFDS) at our offices for an informative session on the regulation of digital health technology.
The European Union Council approved legislative changes to the Medical Device Regulation (EU MDR), finalizing a 3-4 ½ year extension on implementation of the new rules for certifying medical devices.…
AdvaMed’s medtech priorities for the 118th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Get the latest on NMPA’s updated guidance for the clinical evaluation of medical devices.
AdvaMed and its member companies are working with the U.S. government on medtech donations for humanitarian aid following the devastating earthquakes in southeast Turkey and northern Syria.
This publication series explores “Software as a Medical Device (SaMD),” its challenges and the ways regulatory bodies try to address them, as well as the expected development of regulations related…
AdvaMed issued a statement from President and CEO Scott Whitaker on the Joint Statement issued by the United States Trade Representative and India’s Ministry of Commerce & Industry at the…
From MDUFA V and the major investments in semiconductor chip manufacturing in the CHIPS Act, to addressing global supply chain issues and supporting our AdvaMed Accel companies, 2022 was a…