Welcome to Immunization Devices Prequalification

WHO prequalification of immunization devices helps to ensure the availability of quality, reliable products for the storage and transport and administration of prequalified vaccines. These products help maintain vaccines at appropriate temperatures, thereby safeguarding their potency in often challenging operating contexts, as well as expanding and extending their availability. In short, WHO prequalification serves to protect the significant resource investments required to develop, procure and deliver life-saving vaccines globally. Most importantly, by optimizing the use of health resources, WHO prequalification contributes to increased access to essential medical products for those who urgently need them and to improved health outcomes.

WHO prequalification of immunization devices also plays an important role in the WHO Expanded Programme on Immunization (EPI). EPI seeks to ensure universal access to all relevant vaccines for all at risk, thereby supporting WHO’s disease elimination and eradication efforts, as well as countries' preparedness for health emergencies.

Key activities

WHO's activities to prequalify immunization devices cover:

  • evaluation of products and devices so that WHO Member States and UN purchasing agencies are assured of their quality and suitability for use in immunization programmes
  • identification of product end user needs, setting of standards that are codified in product performance specifications and testing protocols
  • verification of product compliance with WHO standards
  • gathering — together with countries and manufacturers — of equipment field performance and user-feedback, to help stimulate innovation and the development of new technologies
  • accreditation of testing laboratories through assessment of their facilities and competencies to test immunization products.

Key criteria for prequalifying immunization equipment and devices

WHO's approach to prequalifying immunization devices is based on three key criteria. The product evaluated must have:

  • performance characteristics that meet the relevant specification standards
  • quality and reliability characteristics that are appropriate for the field conditions where it will be used
  • cradle-to-grave safety characteristics that ensure that no harm is caused to users, patients, or to the environment, over the course of the it's life cycle.

International standards as the basis

Wherever possible WHO adopts international standards as a basis for evaluating the design, development and production of each product type. If these do not yet exist, it works with industry and partners to define appropriate design criteria. WHO prequalification contributes to bringing WHO into a more productive relationship with end users, key partners and industry through a three-step innovation, product development and improvement cycle supported by user feedback, whereby:

  • technical specifications and related test procedures that adequately reflect programmatic and operational needs are developed for each product
  • each product in the market is monitored for performance, quality and safety during its life cycle, from the perspective of the user
  • the suitability of each product in terms of programmatic and operational needs is monitored and all products are subject to a formal annual review process.