In a draft guidance released in September 2019, Singapore’s Health Sciences Authority is seeking feedback from medical device industry stakeholders on the development of new regulations on next-generation sequencing (NGS) in vitro diagnostic devices.
The proposed new regulations are limited to devices that use NGS in vitro diagnostic technology either to profile and diagnose tumors or to diagnose suspected germline diseases.
Among the information that would be required to register NGS-based in vitro diagnostic devices are preclinical and clinical studies, IVD test controls, sequencing, and data analysis, DNA/RNA extraction and processing, sample collection and processing and information on interrogated regions of the genome.
The new requirements will not be finalized until the HSA receives and deliberates on feedback from stakeholders.