Invitation to submit applications for WHO’s prequalification assessment
IVD
WHO is pleased to announce that the Prequalification of IVDs programme scope has been expanded to the following types of products:
New IVD prequalification listing
IVD
On 18th December the Loopamp MTBC Detection Kit manufactured by Eiken Chemical Co., Ltd. was prequalified.
Rusan’s azithromycin tabl and Ipca’s albendazole tabl prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Active Pharmaceutical Ingredient (API) Prequalified
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Levonorgestrel manufactured by Jiangsu Lianhuan Pharmaceutical Co., Ltd.
First EUL to PQ transition of IVDs
IVD
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):
WHO webinar on changes to the PQ procedure for IVDs - 17 Dec 2025
IVD
On 17 December 2025 the Assessment of Medical Devices Team held a webinar for stakeholders to introduce changes which will be implemented to the prequalification assessment
WHO Prequalification Workshop for Chinese manufacturers of IVDs - Guangzhou 9-11 December 2025
IVD
