Diagnostic Products

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:

  • Complying with World Health Organization guidance on storage and distribution
  • Ensuring that products are used by appropriately trained and suitably qualified persons only
  • Using best efforts to participate in suitable external quality assessment programs
  • Using best efforts to organize calibration and maintenance of relevant equipment
  • Using best efforts to develop systematic reporting of product defects

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.

Eligibility of 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:

  1. Prequalification by the World Health Organization Prequalification Programme for in vitro diagnostics
  2. For tuberculosis products, recommendation by the relevant World Health Organization program
  3. Authorization for use by one of the regulatory authorities of the founding members of Global Harmonization Task Force, when stringently assessed (with a high-risk classification): This option is not applicable to rapid diagnostic tests for HIV self-testing
  4. Acceptability for procurement using grant funds, as determined by the Global Fund, based on the advice of the Expert Review Panel

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.

World Health Organization Prequalification Programme

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.

Stringent Regulatory Assessment of Diagnostic Products

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 of the founding members of the Global Harmonization Task Force become eligible for procurement within Global Fund grants unless there are particular requirements (such as for diagnostic products for HIV self-testing).

Expert Review Panel

In certain circumstances, 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, as applicable. 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.

Eligible products

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.

COVID-19 response: Quality assurance

COVID-19 impacts health product supply globally, and the Global Fund is working to minimize disruption to health systems in the countries we support.

We are exercising flexibilities to ensure the continued flow of quality-assured health products and support countries in their response to the pandemic. Our operational guidance lays out new quality assurance requirements for procuring COVID-19 diagnostic products with Global Fund financing.

Read more on our COVID-19 Health Product Supply page.

Additional requirements

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.

Recipients shall arrange for the monitoring of the quality of diagnostic products procured with grant funds in line with relevant World Health Organization Guidelines on Post-Market Surveillance of In Vitro Diagnostics.