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What is the scope of work of WHO prequalification of immunization devices?

FAQ
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WHO works to ensure the availability of immunization devices that are fit for use by Expanded Programme on Immunization programmes, and to provide manufacturers with a fair basis for tendering products and investing in product development. It:

  • sets and applies standards and norms in the form of product specifications which define the performance, quality and the safety characteristics required for specific operating environments
  • defines the product testing and verification protocols used to determine whether a product meets the specified criteria
  • evaluates whether products meet these performance specifications and are eligible for prequalification by WHO, for use in immunization programmes
  • reviews product performance to determine whether the prequalified status of a product or device can be maintained or should be withdrawn
  • collects product performance feedback from WHO Member States and product manufacturers, and gathers information from product end users about their evolving needs to help stimulate innovation
  • assesses for accreditation the facilities and competencies of laboratories for testing immunization products that are being evaluated for prequalification.