In vitro diagnostics and laboratory technology

Streamlining of the Prequalification of Diagnostics

Streamlining of the Prequalification of Diagnostics

WHO is undertaking to streamline the prequalification assessment procedure for in vitro diagnostics.

Efforts to streamline the WHO prequalification assessment procedure

WHO has acquired four years of experience in the prequalification assessment of in vitro diagnostics, thus it was timely to undertake a review of the current WHO procedures and processes to assess areas for improvement. Beginning at the start of 2014, WHO has consulted with technical experts and stakeholders to re-shape the WHO prequalification assessment procedure.

Stakeholder Meeting in Geneva

On 4 April 2014, the Prequalification Team – Diagnostics Assessment presented the plans for streamlining of the prequalification assessment procedure. A number of presentations were given and the opportunity for the invited stakeholders to comment on WHO’s planned new processes.

Industry Briefing using WebEx video conferencing

On 15 and 16 May 2014, the Prequalification Team – Diagnostics Assessment conducted a briefing specifically for the IVD industry. Presentations were given on:

Presentations

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