Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

The Medical Devices Cluster (MDC) has released a draft update to GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices for stakeholders' consultation.

Key updates include:
- Clarification notes on the classification of control materials and software
- Clarifications to the risk classification rules 1-5

We would like to invite our stakeholders to provide feedback on this document: For Consultation GN-14 Guidance on the Risk Classification of In Vitro Diagnostic MD

The Consultation period for this document is from 2 May 2023 to 30 May 2023. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 30 May 2023. Please indicate "Feedback on GN-14" in the email subject header.

GN-14 Guidance Feedback Form

Published: 2 May 2023

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