Consultation on GN-20 Guidance on Clinical Evaluation

The Medical Devices Cluster (MDC) has released a draft of GN-20 Guidance on Clinical Evaluation for stakeholders' consultation. The updates present HSA's position on the use of real-world data in medical device clinical evidence and also some specific clarifications on clinical evaluation for software medical devices. We have also aligned the contents with IMDRF guidance on clinical evaluation, where applicable.

These ensure that the guidance reflects the latest thinking on essential topics relating to clinical evaluation. We would like to invite our stakeholders to provide feedback on the updates to GN-20  Guidance on Clinical Evaluation.

For Consultation - GN-20 Guidance on Clinical Evaluation (2023 Nov)868 KB

The Consultation period for this document is from 27 October 2023 to 30 November 2023. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 30 November 2023 and with "Feedback on GN-20" in the email subject header.

GN-20 Guidance Feedback Form20 KB

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