UNFPA Technical Requirements for Medical Devices

Technical Requirements for Medical Devices

2013
Technical Requirements for Medical Devices.pdf
Author: UNFPA

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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
A new Expression of Interest for the ERP process was published in April 2017
 

PHARMACEUTICAL PRODUCTS

Please check the Interagency finished pharmaceutical product questionnaire.