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WHO prequalification of immunization devices is a collaborative effort between WHO, WHO Member States, technical agencies, manufacturers and donors. Its purpose is to ensure the availability of quality, reliable immunization products in order to help safeguard vaccine potency, as well as expand and extend their availability.
It achieves this by:
- enforcing and setting quality and performance standards that reflect product end user needs and help shape technologies to meet evolving user requirements
- providing assurance to national and international procurers that products adhere to the desired standards of quality and safety and meet the performance requirements of low-resource settings
- helping manufacturers to improve their capacity to meet quality standards for existing products and desirable new technologies
- adhering to rigorous laboratory testing protocols.