Ministry of Food and Drug Safety and Singapore Jointly Develop AI Medical Device Clinical Trial Guidelines

The National Institute of Food and Drug Safety Evaluation under the Ministry of Food and Drug Safety announced on the 11th that it is collaborating with the Health Sciences Authority (HSA) of Singapore to jointly develop guidelines for clinical trials of AI medical devices. These guidelines aim to provide direction on conducting clinical trials for machine learning-based medical devices, covering aspects such as trial design, patient and trial dataset selection, clinical reference standard selection, clinical data interpretation, primary efficacy endpoints, and outcome analysis. The guidelines apply to clinical trials of AI medical devices in South Korea and Singapore and will be used by the HSA to assess the suitability of clinical trials when certifying and approving products.

The collaboration is expected to reduce the time and cost of obtaining product certification in each country, the agency said..