Implementers of Global Fund-supported programs must ensure the medical devices and core personal protective equipment they purchase meet the Global Fund’s Quality Assurance Policy for Medical Devices (including In-Vitro Diagnostics) and Core Personal Protective Equipment.
- Quality Assurance Policy for Medical Devices (including In-Vitro Diagnostics) and Core Personal Protective Equipment
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We promote best practices in the procurement of medical devices and core personal protective equipment, including:
- Complying with World Health Organization (WHO) guidance on storage and distribution;
- Ensuring that products are used by appropriately trained and suitably qualified persons only;
- Ensuring that medical equipment is adequately maintained and calibrated at regular intervals;
- 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 medical devices and core personal protective equipment (in most cases, the Principal Recipient) should ensure they observe all applicable national 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 different options when selecting which medical devices, core personal protective equipment or condoms to purchase. They can choose products that meet one of these options:
- Prequalification by the WHO Prequalification Programme or United Nations Population Fund (for condoms only);
- Authorization for use by one of the regulatory authorities of the founding members of Global Harmonization Task Force, when stringently assessed;
- Authorized for use by a WHO-listed Authority (under certain modalities);
- 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 medical devices and core personal protective equipment, additional requirement that are specific to the type of health product are to be met. The detailed additional quality requirements are detailed in sections 11 and 12 of the Quality Assurance Policy for Medical Devices (including In-Vitro Diagnostics) and Core Personal Protective Equipment.
Stringent Regulatory Assessment
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.
United Nations Population Fund (UNFPA)
UNFPA manages the prequalification programmes for male latex condoms and female condoms. The findings are used to provide independent technical information on the safety, quality and performance of the products assessed to other UN agencies, WHO Member States and other interested organizations.
World Health Organization Prequalification Programme
The World Health Organization manages a program that prequalifies currently pharmaceutical products and in vitro diagnostics that are considered acceptable for procurement by the United Nations and specialized agencies. A future prequalification work stream for medical devices and potentially Core Personnel Protective Equipment is in the process of being established.
WHO Listed Authority (WLA)
The WHO started a Listed Authority initiative (WLA) to provide a transparent and evidence-based pathway for more regulatory authorities to be globally recognized. This is intended to expand access to a regionally diverse supply of safe, efficacious, effective, and quality health products. Newly listed authorities are expected at the beginning of 2024.
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 medical devices and core personal protective equipment found eligible under our quality assurance policy, to help Principal Recipients more easily identify the status of products.
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.
Additional Requirements
The medical devices and core personal protective equipment selected should be from manufacturers whose manufacturing sites are compliant with the requirements of ISO 13485, as applicable, or of an equivalent quality management system recognized by one of the regulatory authorities of the ex-founding members of the Global Harmonization Task Force or by a WHO Listed Authority. 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 medical devices and core personal protective equipment procured with grant funds in line with relevant WHO or other international guidelines on post-market surveillance of medical devices and core personal protective equipment.