February 2018: Capacity Building Training on in-vitro Diagnostic Medical Device Evaluation in the Philippines
The Research Institute for Tropical Medicine (RITM) in the Philippines participated in training conducted by NRL on in-vitro diagnostic medical device (IVD MD) evaluation establishment, management and operations. According to the ASEAN Medical Device Directive, National Authorities of each ASEAN country are tasked to evaluate IVD MDs as part of pre-market and post-market regulations. In the Philippines, the Food and Drug Administration (FDA) is tasking the National Reference Laboratories to perform the IVD MD evaluation. Susie Braniff from NRL facilitated a four day training workshop in Manila between 6 – 9 February for 26 staff involved in the national IVD evaluations programme.
Presentations on international approaches to test kit evaluation with reference to the Essential Principles and Risk Classification of IVDs established by the Global Harmonisation Task Force, as well as the technical aspects of IVD selection and laboratory performance testing were delivered in the Workshop. Each lecture-based sessions was paired with an activity to encourage the application of theory into practice and promote discussion of the possible challenges that may arise. For future planning the options for post-market surveillance of IVD MDs registered for use was also discussed.
NRL would like to thank the participants for their hard-work throughout the training workshop and their commitment to the development of the national IVD evaluation programme. In addition, NRL would like to acknowledge the management team at RITM for arranging the workshop to support laboratory capacity building.