Requirements for medical devices, IVD and PPE

UNICEF’s technical requirements for medical devices, in vitro diagnostics (IVD) and personal protective equipment (PPE)

UNICEF’s medical devices, which are listed in the Supply Catalogue, comply with the strictest international quality standards.

Selected manufacturers and products must meet requirements that conform to international quality management system standards, norms, rules and regulations for medical devices. The documents below detail the requirements that UNICEF applies to medical devices, in vitro diagnostics devices and personal protective equipment (PPE).

09/06/2022

Technical requirements for medical devices

UNICEF's requirements for medical devices suppliers and products.
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18/02/2016

Technical requirements in vitro diagnostics (IVD)

UNICEF's requirements for in vitro diagnostics suppliers and products.
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18/06/2019

Technical requirements for personal protective equipment

UNICEF's rerquirements for personal protective equipment suppliers and products.
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More to explore

WHO Prequalification of In Vitro Diagnostics

UNICEF’s procurement of HIV/AIDS, malaria, syphilis and hepatitis B and C test kits is based on the WHOs Prequalification of IVD Assessment Procedure.

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Global Fund IVD quality assurance

UNICEF’s procurement of HIV/AIDS, Malaria, Syphilis and Hepatitis B and C test kits is in line with Global Fund IVD quality assurance framework.

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United Nations Global Marketplace (UNGM)

All UNICEF suppliers must be registered and approved with the UNGM, the official procurement platform of the United Nations.

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Quality assurance

Ensuring the efficacy and safety of the goods and services UNICEF procures for children.

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