Singapore: Public Comments on Revised Draft of GN-20: Guidance on Clinical Evaluation
The Health Sciences Authority (HSA) Singapore revised Guidance Document: GN-20 Guidance on Clinical Evaluation. The updates reflect their current position on the use of real-world data in medical device clinical evidence as well as clarify related contents with IMDRF guidelines. The HSA is currently soliciting industry comments for this revision.
This drafted document provides major revisions that emphasize:
- Clinical evidence is essential to meet the Essential Principles of Safety and Performance (EP) under HSA.
- Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device and aligned to the risk management process – ISO 14971.
- Clinical evaluation report documents the outcome of clinical evaluation processes and forms part of the technical documentation of a medical device.
- This guidance document should be read in conjunction with (not limited to) identified regulatory guidelines.
- Examples of real-world data: data from registries, AE databases, and medical records.
- Clarity on the definition and explanation of key terminologies used throughout the document, for example: comparable device, performance, etc.
- Expectation of clinical evaluation including clinical performance studies to be gathered from good study practices, accredited 3rd party clinical laboratories, and appropriate study design for IVDs.
- Expectation of clinical evaluation in terms of clinical association between software’s output and clinical condition (based on intended purpose). This could be performed by continuous monitoring and data collection after SaMD has been deployed in the market.
- Considerations for comparability of devices, applicable clinical data generated from different jurisdictions & establishing criteria to appraise different clinical data sets.
Please refer to the following to submit your feedback:
- Feedback period: 27 Oct 2023 to 30 Nov 2023
- Feedback form: GN-20 Guidance Feedback Form
- Feedback method: Email to HSA at HSA_MD_INFO@hsa.gov.sg with subject header “Feedback on GN-20”
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