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Strengthening the Quality Management System for Manufacturers of Local Medical Device through WHO Prequalification (WHO-PQ)

News
28 June, 2023 - 17:00 (CEST)
IVD

In collaboration with the WHO Indonesia Country Office the PQT-IVD Team contributed to a workshop hosted by the Directorate of Pharmaceutical and Medical Devices Resilience, Ministry of Health, Indonesia on June 27th, 2023. The objectives of the workshop were to discuss Indonesia’s progress and challenges with local manufacture of medical devices and to provide a clear understanding of the prequalification process and requirements for manufacturers of in vitro diagnostics (IVDs). The hybrid session allowed for direct interaction between manufacturers and the PQT-IVD Team enabling clarification of PQ assessment steps and technical specifications, such as the design of clinical studies to be conducted by the manufacturer. The information shared was well received by the Indonesian Ministry of Health and participants from industry and has paved the way for further engagement by local manufacturers with WHO prequalification.