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Prequalification Guidance for Applicants & Prequalification Holders

Prequalification Guidance for Applicants & Prequalification Holders

WHO provides the following guidance to Applicants & Prequalification Holders.

IMD-PQS Prequalification Guidelines

Applicable to all product categories, and for all manufacturers and licensed reseller, these guidelines explain step-by-step how to make an application for prequalification and how to maintain prequalified status.

Download here: Complete IMD-PQS Prequalification Guidelines (70pps)

 

"Pocket Guide"

An abbreviated version of the Prequalification Guidelines is available. It offers a brief overview of the IMD-PQS procedures and prequalification requirements, complemented by sign posts to each relevant full-length section in the complete guidelines.

Download here: IMD-PQS Pocket Guide (10pps)

 

Generic guide for the field evaluation of new technologies

Guides manufacturers on how to begin and properly plan for a field test, including assembling a team and establishing research objectives. Provides a detailed outline of the end-to-end field evaluation process, including steps and roles and responsibilities of the different stakeholders.

Download here: Generic guide for the field evaluation of new technologies

 

Prequalification Holders should ensure to inform the IMD-PQS Secretariat at all times in case of any errors or incorrect information on their products' Data Sheet.

Use the relevant form from the following list to provide information to IMD-PQS about the corrections required. Return the completed form by email to Isaac Gobina ([email protected]) and Paul Mallins ([email protected]) and Lauren Goodwin ([email protected]).

IMPORTANT NOTE - This form is not intended to report desired post-prequalification "variations" or changes; i.e. changes to product administrative information or technical details that are undertaken by the manufacturer after prequalification. Post-prequalification variations must be submitted via the ePQS platform.

WHO provides additional technical guidance documents of relevance to specific categories:

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