Regulatory Updates
Consultation on Requirements for Registration of Next Generation Sequencing In-vitro Diagnostic Medical Devices (NGS IVDs)
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 July 2019
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[Updated on 31 July 2019]
The Medical Devices Branch (MDB) has released a draft document on the Requirements for Registration of NGS IVDs. This document covers the technical requirements for NGS based IVDs for germline diseases and tumour profiling. We would like to invite our stakeholders to provide feedback on this document:
Requirements for NGS IVDs (for consultation) [PDF, 1280 KB]
The Consultation period for this document is from 31 July 2019 to 31 August 2019. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 31 August 2019. Please indicate "Requirements for NGS IVDs Feedback" in the email subject header.