Diagnostic Products

Diagnostic products procured with Global Fund resources must adhere to the Global Fund Quality Assurance (QA) Policy for diagnostic products, issued on 14 December 2010 and most recently amended on 4 May 2017.

Diagnostic products means all durable and non-durable in-vitro diagnostic products (IVD), imaging equipment and microscopes used for diagnosis, screening, surveillance or monitoring purposes.

Quality standards for diagnostic products

Section 7 of Global Fund QA Policy for diagnostics states that Grant Funds may only be used to procure diagnostic products that meet the following standards:

    1. IVDs and imaging equipment manufactured at a site compliant with the requirements of ISO 13485:2003 or an equivalent quality-management system recognized by one of the regulatory authorities of the Founding Members of GHTF[1]; and
    2. any diagnostic product for which Section 7 (i) above does not apply, such as microscopes, manufactured at a site compliant with all applicable requirements of the ISO 9000 series or an equivalentquality-management systemrecognized by one of the regulatory authorities of the founding members of GHTF.

Section 8 of the Global Fund QA Policy for diagnostics states that, in addition to the requirements of Section 7 above, diagnostics products with regards to HIV, tuberculosis and malaria and to hepatitis B, hepatitis C and syphilis co-infections, as well as IVDs providing information that is critical for patient treatment of these diseases, such as testing for G6PD deficiency, shall meet any one of the following standards:

    1. prequalification by the WHO Prequalification of In Vitro Diagnostics Programme; or
    2. for tuberculosis: recommendation by relevant WHO programme; or
    3. authorization for use by one of the Regulatory Authorities of the Founding Members of GHTF when stringently assessed (high risk classification)[2]; or
    4. acceptability for procurement using Grant Funds, as determined by the Global Fund, based on the advice of the WHO Expert Review Panel.

The quality assurance page on the Global Fund website provides further guidance on QA requirements and how to ensure that the most recent version of documents and templates are used.

 

[1] GHTF—the Global Harmonization Task Force—has now been replaced by IMDRF—the International Medical Devices Regulators Forum (conceived in February 2011). IMDRF members are: Australia, Brazil, Canada, China, European Union, Japan, the Russian Federation and the United States. IMDRF observers are: WHO and Asia-Pacific Economic Cooperation (APEC). IMDRF affiliates are: Asian Harmonization working party and the Pan American Health Organization (PAHO). For further information, see: http://www.imdrf.org/.

[2] This option is not applicable to RDTs for HIV-Self-Testing.