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.