Health Sciences Authority (HSA) has finalized the specific requirements for registration of Next Generation Sequencing based In-vitro Diagnostic medical devices (NGS IVDs), which can be accessed here. This 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.
Source: Health Sciences Authority
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