Singapore’s HSA Makes Public a New Draft Guidance for Device Clinical Evaluation

In late October, the Singapore HSA requested that relevant players provide feedback on their draft Guidance for Device Clinical Evaluation. Before medical device registration in Singapore, a medical device must show clinical evidence aligning with the appropriate – Essential Principles of Safety and Performance of Medical Devices. This Draft Guidance, which improves the current GN-20 regulation, specifically addresses the use of real-world data for device clinical evaluation. Real-world data is defined as data not included in a traditional clinical investigation on the device being registered or a similar device. Things like past adverse events, recalls, or other post-marketing information gathered in the use of the device in question in other markets can be useful in medical device evaluation.

In addition, the draft guidance also states that while standalone software (SaMD) needs to follow the HSA’s existing regulations, it must also meet similar clinical evaluations. SaMD that feeds in data and yields results via AI dynamic programming, etc. needs to undergo clinical evaluations to confirm that its safety and efficacy meet the software’s intention in the specific clinical setting it is used for. Once feedback is received on this draft guidance, we believe the HSA will promulgate the final GN-20 update.