Maintaining the quality and performance of medical devices circulating in the market is vital. Achieving the required quality, safety, and performance of the medical devices involves assessment of a medical device’s technical file before granting authorization for sale or distribution.
The AMDF has already published a set of Guidelines on different regulatory functions related to medical devices. To complement that set and recognizing the sensitivity and vulnerability of mothers, newborns and children and the unique requirements of medical devices for maternal, newborn, and child health (MNCH), AMDF has just launched a guidance document of considerations for regulation of MNCH medical devices.
Join this virtual orientation session for medical device assessors from the African continent on the technical resources available to guide regulation of medical devices and on the specific considerations for regulation of MNCH medical devices.
Zoom link: https://zoom.us/webinar/register/WN_YUdigRksThGDhN1i6tdYvA
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