Singapore’s Health Sciences Authority (HSA) has finalised the updated GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices, based on the various feedback and comments received from stakeholders during the consultation period conducted in May 2023.
Key updates to GN-14 include:
– Clarification notes on the classification of control materials and software
– Clarifications to the risk classification rules 1-5
The finalised version of GN-14 can be accessed here:
https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-14-r3-guidance-on-the-risk-classification-of-in-vitro-diagnostic-md-(2023-jul)-pub.pdf