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Diagnostic Products and Medical Devices

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 mean 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[1] 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 or an equivalent quality-management system recognized by one of the regulatory authorities of the Founding Members of GHTF[2]; 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 equivalent quality-management system recognized 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)[3]; 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.

UNDP technical and regulatory requirements for IVDs

The UNDP Quality Assurance (QA) policy[4] aligns with the requirements outlined in the Global Fund QA policy. Within the UNDP QA framework, the qualification process encompasses key stakeholders: the supplier, manufacturing site(s), and product. A crucial aspect of the evaluation relies on the information submitted by the bidders. The technical and regulatory requirements outlined for in vitro diagnostic products[5] guide bidders to adhere to UNDP’s QA policy. The requirements cover all the different risk classifications of IVDs based on the IMDRF classification, from low risk to high risk.

Some examples of in vitro diagnostic device classification [4,6,7] are listed in the below table. However, these examples are for general understanding, and the actual classification of a specific device must be considered individually, taking account of its design, and intended use.

vitro diagnostic device classification

Medical Devices (MDs)

Medical devices procured by UNDP must adhere to the requirements set out in the UNDP QA policy [4]. The UNDP QA system for medical devices is based on the guidelines of the International Medical Devices Regulator Forum (IMDRF) for Medical Devices[2]. It also aligns with QA policies from other UN agencies and international organizations such as The Global Fund [1,8].

UNDP technical and regulatory requirements for MDs

Within the UNDP QA framework, the qualification process encompasses key stakeholders, namely the supplier, manufacturing site(s), and the product. A crucial aspect of the evaluation relies on the information submitted by the bidders. The technical and regulatory requirements outlined for medical devices [9] guide bidders to comply with UNDP’s QA policy. This document specifies the criteria that UNDP utilizes in the procurement process for medical devices. The requirements cover all the different risk classifications of medical devices based on the IMDRF medical devices classification, from low risk to high risk.

Some examples of medical device classification [10] are listed in the table below. The actual type of each device depends on the manufacturer’s claims and intended use. However, these examples are for general understanding, and the precise classification of a specific device must be considered individually, considering its design and intended use.

medical device classification medical device classification

[1] Quality Assurance of Diagnostic Products

[2] 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/

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

[4] QA_policy_Health_Products.pdf (undp.org)

[5] UNDP Technical & Regulatory Requirements for In Vitro Diagnostic Devices (IVDs)

[6] Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (imdrf.org)

[7] IVD Risk-based Classification | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

[8] Guide to Global Fund Policies on Procurement and Supply Management of Health Products, June 2021 (theglobalfund.org)

[9] UNDP Technical & Regulatory Requirements for Medical Devices

[10] GHTF SG1 Principles of Medical Devices Classification - November 2012 (imdrf.org)

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