Singapore Health Sciences Authority (HSA) final document presents the specific requirements applicable for NGS IVDs that are to be submitted for registration. The scope of this document covers both NGS based IVD tests intended to aid in diagnosis of individuals with suspected germline or somatic mutation-related diseases and NGS based tumour profiling IVD tests.
HSA conducted a consultation on “Registration of Next Generation Sequencing based In-vitro Diagnostic medical devices (NGS IVDs)” from 31 July 2019 to 31 August 2019. Based on the feedback and suggestions from the consultations, the finalized requirements for registration of Next Generation Sequencing based in-vitro diagnostic medical devices can be accessed here.
This guidelines top-up to the list of the
Product Specific Regulatory Guidelines:
FAQ Telehealth Products
Next Generation Sequencing NGS IVDs
To see the fianl guidelines, please download Attachment 1.
Source: Singapore HSA