The WHO Immunization Devices, Performance, Quality and Safety initiative (WHO IMD-PQS) is the group within the WHO prequalification that prequalifies products used to transport, store, monitor, administer and safely dispose of vaccines. WHO prequalification enables Member States and UN procurement agencies to be assured that products have been evaluated and deemed suitable and reliable for immunization programmes. IMD-PQS contributes to the broad access agenda of WHO which seeks to strengthen regulation of health products and expand access to quality-assured products in countries that have a heavy disease burden, including vaccine-preventable diseases.

IMD-PQS works to ensure that: WHO Member States' national immunization programmes have access to products that have the requisite characteristics; that UN and other procurement agencies can procure products that are fit for purpose; and that prospective Prequalification Holders (manufacturers) have a fair basis for tendering products and investing in the development of future innovation. It does this by:

• setting standards and norms in the form of product specifications that define the performance, quality and the safety characteristics required for specific operating environments
• defining the product testing and verification protocols for determining whether a product meets the specified criteria
• evaluating whether products meet these performance specifications and are eligible for prequalification for use in immunization programmes
• reviewing product performance to determine whether the prequalified status of a product or device can be maintained or should be withdrawn
• assessing laboratories for accreditation to test immunization products undergoing evaluation for prequalification
• collecting product performance feedback from WHO Member States and Prequalification Holders, and gathering information from product end-users about their evolving needs to help stimulate innovation.

Our key outputs

The key outputs of WHO immunization devices prequalification are:

• the Catalogue of WHO-prequalified Immunization Devices
• performance specifications for immunization products
• product verification protocols for the testing and evaluation of products
• target product profiles that define the desirable characteristics for future innovations
• the WHO list of laboratories that are accredited to test for product compliance with prequalification standards
• guidance for Applicants and research organizations carrying out field evaluations.

The IMD-PQS process

Overview of IMD-PQS impact and mandate

A Powerpoint Introduction to Immunization Devices Prequalification impact, mandate, outputs and processes can be downloaded here: