The Medical Device Regulatory Convergence (MDRC) Project in collaboration with the African Medical Device Forum and the US Food and Drug Administration, prepared a program that was delivered in a hybrid format in Nairobi, Kenya from 6 to 09 November.
This workshop will provide an exchange of information and capacity building between the AMDF, its member NRAs and partner reference NRAs including the USFDA, TGA, HSA, ANVISA, also the Africa CDC and industry covering the core international references for medical device regulatory frameworks including the following core topics: IMDRF, international standards including ISO 13485 and ISO 14971, conformity assessment, MDSAP, Post-Market Activities, Good Reliance Practices, Proper Legal Foundations for Rulemaking including Good Regulatory Practices (GRP) and Technical Barriers to Trade (TBT), USFDA Regulation of Medical Devices, Reference NRA experiences, and other related topics. The workshop objective is to support and advance the AMDF 2023 Workplan and Training Plan in furtherance of the AMDF 5-year strategic plan accelerating African MD NRA capacities, to support the AMDF application as a Regional Harmonization Initiative (RHI) of the IMDRF, to strengthen the soft infrastructure of medical device regulatory frameworks on the continent to incorporate global lessons learned from the COVID-19 pandemic, to better prepare for future health emergencies, to prevent the implementation of unnecessary regulatory barriers to medical technologies, to improve general MD NRA public administration and general public health. The workshop will also support acceleration of diagnostics access in Africa in collaboration with the Africa CDC support to AMDF medical device work through the Diagnostic Advisory Committee (DAC).
The event will be delivered in a hybrid format for which either in-person or virtual participation is welcomed by registering here by 30 October.