Eligibility criteria of WHO Prequalification of In Vitro Diagnostic Product|WHO-PQ IVDs|Lecture-2 @ivdmanufacturing7208
WHO in vitro diagnostics (IVDs) prequalification primarily benefits underserved populations in low- and middle-income countries — that have little or no domestic regulatory frameworks for IVDs — and whose need for diagnosis, initiation and monitoring of treatment for high-burden diseases is considerable.
It also supports procurers, regulators, laboratories, manufacturers and donors, in reaching national and international public health objectives.
Eligibility principles
Any IVD submitted for prequalification must be:
needed for a specified disease or disease state
appropriate for use in resource-limited settings
requested by a WHO Member State(s)
recommended for use by WHO disease-specific testing guidelines.
Eligibility criteria
In addition, a number of eligibility criteria are applied. That is, each product submitted for prequalification must:
be manufactured by the original product manufacturer
commercially available when submitted for prequalification assessment*
of interest to UN organizations and other agencies carrying out procurement of IVDs
belong to a product category for which there are as yet no or few prequalified products.
* Any exemptions must be agreed upon by WHO before the submission of the application. Please contact WHO at diagnostics@who.int if you have any questions regarding product eligibility with regard to your product's commercial availability.
Importantly, IVD prequalification also undertakes prequalification of male circumcision devices to accelerate delivery of male circumcision programmes in settings where HIV incidence is high, and helping to reduce risk of HIV infection in adult male populations.
List of Queries-
What is WHO Prequalification of In Vitro Diagnostics Product ?
What is WHO-PQ IVDs?
What is the benefits of WHO-PQ?
WHO-PQ IVDs kya hota hai ?
WHO-PQ kya hai ?
World Health Organization PQ kya hai?
WHO-PQ Guidelines ?
WHO-PQ Product
Prequalified List pf IVD Products
General information – WHO List of Prequalified In Vitro Diagnostic Products
In Vitro Diagnostics Eligible for WHO Prequalification
Eligibility principles
Eligibility criteria
IVD products currently eligible for submission for prequalification
Prequalification Procedures and Fees: In Vitro Diagnostics
Who can participate in WHO prequalification of IVDs?
What are the steps of IVD prequalification?
Full assessment or abridged assessment
What happens when an IVD is prequalified?
Duration of validity of prequalification status
Post-prequalification
Prequalification fees
Prequalification Reports
Public Reports
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