Singapore, Health Sciences Authority (HSA) released the final document on Next Generation Sequencing NGS IVDs.
This document focuses on the requirements of NGS IVDs for registrations.
The scope covers both NGS based IVD tests intended to aid in the diagnosis of individuals with suspected germline or somatic mutation-related diseases and NGS based tumor profiling IVD tests.
These guidelines add to the list of the Product-Specific Regulatory Guidelines:
• Telehealth Products
• FAQ Telehealth Products
• Aesthetic-Related Guidelines
The guidelines can be found at https://www.hsa.gov.sg/medical-devices/guidance-documents