July 2017: NRL Workshop on Evaluation of In Vitro Diagnostic (IVD) Medical Devices in Vietnam
On behalf of the World Health Organisation (WHO) office in Vietnam Susie Braniff from NRL delivered a four day training workshop entitled “Evaluation of In Vitro Diagnostic (IVD) Medical Devices” in Hanoi from the 04 – 07 July, 2017. The first 3 training days brought together 42 technical experts from the organisations that currently contribute to the national IVD dossier review programme.
Approaches to the evaluation of IVDs were presented along with a breakdown of the required administrative and technical elements of an IVD dossier. Multiple practical sessions gave participants the opportunity to apply their analytical skills for evaluating the material provided in IVD dossiers being considered for registration. On the final day 14 participants from the Department of Medical Equipment and Construction (DMEC) focussed on standardising methods for data analysis and reporting, as well as a planning discussion on the current and future structure of the IVD medical device evaluation programme in Vietnam.
NRL would like to thank the technical experts contributing to the IVD dossier review in Vietnam for their active participation in the training and the team members from DMEC for their commitment to strengthening the national IVD evaluation programme. In addition, NRL would like to acknowledge the Ministry of Health, Vietnam and the WHO Vietnam office for their continued support of laboratory capacity building.