- All > Quality and Safety: Medicines > Quality Assurance
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- All > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > prequalification - eligibility for prequalification assessment
- Keywords > prequalification - In Vitro Diagnostics assessment
- Keywords > prequalification - IVDs for use in treatment programmes
- Keywords > prequalification - vaccines, medicines, diagnostics and medical devices
- Keywords > prequalification of diagnostics
- Keywords > prequalification process
- Keywords > in vitro Diagnostic (IVD)
(2017; 0 pages)
WHO prequalification of IVDs is a comprehensive quality assessment of individual IVDs through a standardized procedure aimed at determining whether the product meets WHO prequalification requirements. Manufacturers applying for WHO prequalification assessment of IVDs are required to complete the form PQDx_015 “Pre-submission form”. The pre-submission form assists WHO to determine eligibility for prequalification assessment and the type of assessment (full or abridged) that the product will undergo. This document is intended to assist manufacturers in correctly completing the pre-submission form.
This form has been designed to assist WHO to capture necessary information about a product submitted for WHO prequalification assessment. The information provided by the manufacturer in this form assists WHO to determine whether a product is eligible for WHO prequalification assessment and, if so, the type of assessment (full or abridged) that the product will undergo. The information in this form is also used in the planning of each of the elements of the prequalification assessment. Therefore, the manufacturer must complete the form with accuracy and completeness.