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Survey on change requests assessment by WHO

IVD
Announcement
16 January - 17 February, 2026 - 12:23 - 18:00 (CET)

This survey aims to gather feedback on the updated PQDx 121 guidance, the new change request submission form, and the overall submission and assessment process.

New IVD prequalification listing

IVD
Announcement
8 January, 2026 - 10:04 (CET)

On 18th December the Loopamp MTBC Detection Kit manufactured by Eiken Chemical Co., Ltd. was prequalified.

 

IVD newsletter - Q4 2025, Issue 51

IVD
Announcement
19 December, 2025 - 11:42 (CET)

The Prequalification of IVDs Q4 2025 Newsletter has been posted on the website.


Related links:  

First EUL to PQ transition of IVDs

IVD
Announcement
17 December, 2025 - 16:28 (CET)

For the first time, two SARS-CoV-2 antigen detection rapid tests have successfully transitioned from WHO’s Emergency Use Listing (EUL) to WHO Prequalification (PQ):