ARTICLE SUMMARY:
In this week’s Pathways Picks: The launch of the African Medicines Agency; draft rules for EU device health technology assessments; new guides from China, South Korea, and Brazil; CDRH publishes its first new guidance documents in months; FDA commissioner makes device user fee commitment despite budget cuts; the MAHA report; AI CPT code efforts; and more.
Global Picks
Updates from Africa, Europe, China, South Korea, and Brazil:
African Medicines Agency. Africa is on the cusp of fully launching its continent-wide agency for centralizing and harmonizing oversight of drugs, vaccines, and medical devices. Even as the top-down structure of the African Medicines Agency (AMA) is still being put into place, there is already an infrastructure established to initiate medtech regulatory efforts. This foundation helped keep track of availability and performance of IVDs for COVID-19, and now it is stepping up to serve a more direct premarket review function for the continent in response to the Mpox (or monkeypox) outbreak in a growing number of African countries. (For more on AMA and medtech harmonization efforts in Africa, see in Market Pathways, “Charting a Continent’s Course: Africa’s Push Toward Harmonized Medical Device Regulation.”)
