Supplies and Logistics

Technical standards - Medical devices and IVD medical devices

UNICEF procures medical devices, including laboratory items, and In Vitro Diagnostic (IVD) medical devices as part of its priority to support early childhood development. The provision of safe, good quality medical devices at reasonable prices is essential to the delivery of quality healthcare to mothers and children. UNICEF’s comprehensive range of essential medical devices is detailed in the UNICEF Supply Catalogue. Many of these items are stocked in the Supply Division warehouse in Copenhagen, ready for rapid delivery. Pre-packed kits are available and customized set packing undertaken upon request from the customer.

The quality of medical devices is a major concern for UNICEF Supply Division. Technical, quality assurance and procurement processes have been established to ensure that both suppliers and products conform to international standards. Products procured by UNICEF must comply with the strictest international quality standards.

Selected manufacturers and products  meet essential requirements in conformity with international quality management system standards, norms, rules and regulations for medical devices.  For further details, please see UNICEF Technical provisions for medical devices and UNICEF Technical provisions for In Vitro Diagnostic (IVD) medical devices. The technical requirements are based on recommendations from the International Medical Device Regulators Forum (IMDRF).

UNICEF’s procurement of HIV/AIDS, Malaria, Syphilis and Hepatitis B and C test kits is based on the WHO Prequalification of Diagnostics programme and in line with Global Fund IVD quality assurance policy.

• Purchases are made from suppliers with a proven record of competence, knowledge and experience

• All suppliers must be registered and approved with the United Nations Global Marketplace (UNGM)

• Product selection is based on generic technical specifications

• Samples of products are tested as part of the bid adjudication process

• All products delivered to UNICEF warehouse are randomly tested

• Supplier inspections are conducted by UNICEF or third party inspections as part of the overall supplier evaluation process



 


 

 

UNICEF SUPPLY CATALOGUE

Details and specifications for UNICEF’s wide range of medical devices, including laboratory items, and diagnostic test kits are detailed in UNICEF Supply Catalogue

GENERAL TECHNICAL PROVISIONS

General Technical Provisions for Medical Devices

General Technical Provisions for In Vitro Diagnostic (IVD) Medical Devices

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