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Report of Africa Medical Devices Forum COVID-19 Task Force - April 2020

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Report of Africa Medical Devices Forum COVID-19 Task Force Guidance on Assessment of Medical Devices including Diagnostic Tests Donations for in-Country use during Emergencies Annex 1 COVID 19 Listed Tests Manufacturers of COVID-19 medical products and supplie Annex 3 Reporting Form for Complaints for Medical Devices including In Vitro Diagnostics

In recognizing the challenges that African Union Member States are facing in accessing information on recommended in vitro diagnostics, other medical devices and personal protective equipment (PPEs) for surveillance and management of COVID-19,Africa Medical Devices Forum (AMDF) Technical Committee leadership and AMRH joint secretariat (WHO and AUDA NEPAD) conducted a meeting on 31 March 2020. The aim of the meeting was to discuss and provide recommendations on how to address the challenges in Africa. During the meeting it was agreed to establish COVID-19 Task Force that can provide technical advice and provide recommendations to the AMDF Technical Committee and subsequently to the AMRH Steering Committee (SC) including National Regulatory Authorities (NRAs). On 2nd April 2020, AMDF established a COVID-19 Task Force comprised of experts from National Regulatory Authorities (NRAs), Laboratories, Research Institutions, African Society for Laboratory Medicines (ASLM), African Centres for Disease Control (Africa CDC) and WHO experts. Within the Task Force four (4) separate working groups were established to address the following four key areas: -

  1. Prepare list of commercial COVID-19 in vitro diagnostics tests which have been assessed using various regulatory approaches to confirm acceptable quality, safety and performance.
  2. Prepare list of selected medical devices and protective, preventive equipment used in COVID-19 management.
  3. Propose mechanism(s) to receive information on substandard and falsified diagnostic tests and other medical devices and dissemination of such information to regulators on the continent.
  4. Prepare a guidance document on management of IVDs and medical devices donations for COVID-19.

The working groups conducted virtual meetings between 6 and 14 April 2020 and provided feedback to the AMDF Task Force on 14 April 2020.