cover image: Interim Guidance Interim Quality Assurance Requirements for the Procurement of COVID-19

20.500.12592/xmb3h6

Interim Guidance Interim Quality Assurance Requirements for the Procurement of COVID-19

29 Jun 2021

All COVID-19 Medical Devices procured with Global Fund resources need to comply with the relevant quality standards that are established by the National Regulatory Authority (NRA) in the country of use and have been authorized for use by the same NRA in accordance with its standard practices for registration or other forms of authorization. [...] Global Fund resources may only be used to procure COVID-19 Medical Devices for class C and Class D that meet either one of the following standards, such as: • Prequalified by the World Health Organization (WHO) Prequalification Programme; • Authorized for use by one of the Regulatory Authorities of the Founding Members of the Global Harmonization Task Force (GHTF)5: or • Recommended for use by the. [...] In addition to Section 7 above, COVID-19 Medical Devices eligible for procurement using Global Fund resources may be: • Products approved pursuant to the WHO Emergency Use Listing (EUL) procedures; and/or • Products approved pursuant to any other emergency procedure set up by one of the Regulatory Authorities of the Founding Members of the GHTF.7 Procuring COVID-19 Medical Devices Reviewed by Expe. [...] The Global Fund Secretariat’s Quality Assurance (QA) Team will examine the decisions of the various Regulatory Authorities in accordance with the QA requirements stated herein and will identify the Medical Devices which satisfy the above-mentioned requirements. [...] The implementation of the above quality assurance requirements related to the emergency procedures will cease when COVI-19 Medical Devices become eligible for procurement following the standard Global Fund QA requirements stated above in order to satisfy country needs.
Pages
10
Published in
Switzerland