For further information and any questions related to quality assurance in UNFPA procurement, please contact:


Quality Assurance team
Procurement Services Branch

Medical Devices

UNFPA ensures that the medical devices it procures comply with international quality standards recommended by WHO and the Global Harmonization Task Force (GHTF), a body that encourages international convergence in regulatory practices related to ensuring the safety, effectiveness, and quality of medical devices. UNFPA therefore evaluates medical devices based on the following criteria:

  • Manufacturer maintains valid marketing licenses
  • Manufacturer maintains valid ISO 13485 and/or ISO 9001 certifications
  • Product meets essential and specific ISO requirements
  • Certificates of Conformity specifying the standard and validity period
  • Product sampling and testing during the bid evaluation stage
  • Product pre-shipment inspection for each purchase order.

Within this category of products UNFPA has developed an Inter-Agency manual for Reproductive Health Kits for Crisis Situations (also available in French and Spanish) that can be consulted here and we are currently working on other new documents. A manual related to birth clinics is currently being developed and will be made public in the upcoming months.