Implementers of Global Fund-supported programs must ensure the diagnostic products they purchase meet our partnership’s quality standards.
Our Quality Assurance Policy for Diagnostic Products applies to all durable and non-durable in vitro diagnostics, imaging equipment and microscopes used in Global Fund-supported programs for diagnosis, screening, surveillance or monitoring purposes:
We promote best practices in the procurement of diagnostic products, including:
The cost of quality assurance and quality monitoring measures must be included in grant budgets. Those responsible for the procurement of diagnostic processes (in most cases, the Principal Recipient) should ensure they observe all applicable laws and regulations. In addition, World Health Organization guidelines or national guidelines should serve as the basis for the selection of particular products.
In accordance with our quality assurance policy, implementers have four options when selecting which in vitro diagnostic products to purchase. They can choose products that meet one of the four options:
In addition to quality management system requirements for manufacturers of in vitro diagnostics, products must meet additional requirements that are detailed in section 8 of the Quality Assurance Policy for Diagnostic Products.
The World Health Organization manages a program that prequalifies pharmaceutical and diagnostic products that are considered acceptable for procurement by the United Nations and specialized agencies. The organization regularly publishes the list of prequalified products, from which Global Fund Principal Recipients can select. Links to more information are below.
Founding members of the Global Harmonization Task Force are the regulatory authorities of the United States, the European Union, Japan, Canada and Australia. In 2012, the task force was replaced by the International Medical Device Regulators Forum, a voluntary group of medical device regulators from around the world that build on the foundational work of the preceding harmonization task force. Products that are stringently assessed by these regulatory authorities become eligible to procurement within Global Fund grants.
If only one or no diagnostic product is available on the global market, a Principal Recipient may select a product that has been reviewed by the Global Fund’s Expert Review Panel and that is permitted for time-limited use.
In cases where a Principal Recipient wishes to purchase products that have been reviewed by the Expert Review Panel, it should obtain evidence of product’s status through the “no-objection letter” process. To do this, the Principal Recipient should complete a notification form and submit it to the Fund Portfolio Manager. The form is available for download below. The Global Fund will issue a no-objection letter for a time-limited period and the procurement can go ahead.
In cases where the Principal Recipient has ordered a product that has been reviewed by the Expert Panel Review and has notified the Fund Portfolio Manager, the Global Fund will conduct quality control testing. This testing is carried out by an independent laboratory contracted by the Global Fund. Once the product has been successfully tested, the Global Fund will approve shipment, notifying both the Principal Recipient and manufacturer.
See our Expert Review Panel page for more information on the panel and its work.
We regularly publish and update lists of diagnostic products found eligible under our quality assurance policy to help Principal Recipients more easily identify the status of products. They are available for download here.
Note that the lists are not exhaustive and a Principal Recipient can use Global Fund grant funds to purchase product(s) not listed on the current list, as long as the Principal Recipient can demonstrate that the product is compliant with the policies mentioned above.
The diagnostic equipment selected should be from manufacturers whose manufacturing sites are compliant with the requirements of ISO 13485 or ISO 9000 series, as applicable, or of an equivalent quality management system recognized by one of the regulatory authorities of the founding members of the Global Harmonization Task Force. All tender and procurement documentation should include a disclosure of the manufacturer and the manufacturing site used.
Any grants procuring rapid diagnostic tests for malaria may undertake lot testing of the kits once they have been received, taking into account the availability of World Health Organization guidance and capacity. Available directly below is a list of accredited laboratories and the procedure for sending samples to the World Health Organization’s Rapid Diagnostic Test Lot Testing Programme at the Western Pacific Region Office.
Additional guidance on quality assurance and diagnostic tests is available for download here.