Glucose Monitoring Devices - Coming Soon to PQT

News

22 December, 2021 - 17:45 (CET)

Announcement

IVD

An online information session about the Prequalification of glucose monitoring devices was held for manufacturers on Friday 5 November. The PQ Team provided an overview of the assessment process, a project timeline for the prequalification of glucose monitoring devices and details of the guidance available for manufacturers. The Technical Specification Series document for glucose monitoring devices will be drafted with assistance from technical experts during the first half of 2022 and it is anticipated that the glucose monitoring devices will become eligible for prequalification assessment in Q3 2022. The workshop included an interactive Q&A session with manufacturers and a recording of the session will be available on the website in January 2022.

Manufacturers and stakeholders will find in the following link, the DRAFT TSS once it is published:

https://extranet.who.int/pqweb/vitro-diagnostics/technical-specifications-series

If you have a question regarding this page or related to this topic, please do not hesitate to contact the PQ team at diagnostics@who.int

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