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WHO Diagnostics Prequalification Potential areas for improvement 4 April 2011 Gene W. Walther Deputy Director Diagnostics Objectives Share my early thoughts on role of PQ Review few areas of work

How to fill out who diagnostics prequalification

How to fill out WHO diagnostics prequalification:

1. Visit the WHO website and navigate to the Diagnostics Prequalification section.
2. Read and familiarize yourself with the requirements and guidelines for the prequalification process.
3. Prepare all the necessary documents and information required for the application, such as product documentation, clinical data, and quality management system details.
4. Complete the online application form by providing accurate and relevant information.
5. Submit the application form along with all the supporting documents via the specified submission method (e.g., online upload, email, or mail).
6. Pay the required application fees, if any, and retain proof of payment.
7. Keep track of the application process and any communications from WHO regarding the prequalification process.
8. If requested, respond promptly to any additional information or documentation requests from WHO.
9. Await evaluation and review by WHO experts. This process may take some time, so be patient.
10. Once the evaluation is complete, you will receive notification from WHO regarding the outcome of the prequalification.

Who needs WHO diagnostics prequalification:

1. Manufacturers of in vitro diagnostic products seeking global recognition and endorsement by the World Health Organization.
2. Donor agencies, governments, and procurement authorities looking to ensure the quality and reliability of diagnostic products being purchased or supplied.
3. Healthcare professionals and organizations aiming to procure and use reliable and validated diagnostic products in their healthcare settings.

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What is who diagnostics prequalification?

Who Diagnostics Prequalification is a process by which medical devices, including tests and testing platforms, are evaluated by the World Health Organization (WHO) for their quality, safety, and performance standards.

Who is required to file who diagnostics prequalification?

Manufacturers and developers of medical devices, tests, and testing platforms are required to file for WHO Diagnostics Prequalification if they want their products to be evaluated and recognized by WHO.

How to fill out who diagnostics prequalification?

To fill out WHO Diagnostics Prequalification, manufacturers and developers need to submit an application, provide necessary documentation and data about their medical devices, tests, and testing platforms, and undergo an evaluation process by WHO.

What is the purpose of who diagnostics prequalification?

The purpose of WHO Diagnostics Prequalification is to ensure that medical devices, tests, and testing platforms meet international quality, safety, and performance standards. It helps countries and organizations make informed decisions about the procurement and use of these products.

What information must be reported on who diagnostics prequalification?

Manufacturers and developers need to report information such as the technical specifications of the medical devices, tests, and testing platforms, the testing and validation data, any relevant clinical studies, and information on manufacturing processes and quality control.