Standards of WHO Prequalification of In Vitro Diagnostic Product|WHO-PQ IVD|Medical Device|Lecture-2

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Standards of WHO Prequalification of In Vitro Diagnostic Product|WHO-PQ IVD|Medical Device|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.

Applicable Standard for WHO -PQ
Standard: A document, established by consensus and approved by a recognized body, that
provides, for common and repeated use, rules, guidelines or characteristics for
activities or their results, aimed at the achievement of the optimum degree of
order in a given context.

In vitro diagnostic (IVD)medical device: A medical device, whether used alone or in combination,
intended by the manufacturer for the in vitro examination of specimens derived
from the human body solely or principally to provide information for diagnostic,
monitoring or compatibility purposes

1. WHO,
2. Global Harmonization Task Force (GHTF)
3. International Medical Device Regulators Forum (IMDRF)
4. Asian Harmonization Working Party (AHWP)
5. International Organization for Standardization (ISO),
6. International Electrotechnical Commission (IEC), and
7. Clinical and Laboratory Standards Institute (CLSI).

Below are the link for different standard -










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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