Taiwan Imposes New Registration, Inspection Requirements on AI-powered Medical Devices

Medical devices which employ artificial intelligence and machine learning will be subject to new inspection and registration guidelines in Taiwan, according to directives published in October by Taiwan’s Food and Drug Administration.

The new structures are designed to ensure that medical device software based on artificial intelligence and machine learning technologies are safe and perform as promised. They are formulated in accordance with guidance developed by the International Medical Device Regulators Forum (IMDRF) and adopted in South Korea, Japan, and the United States.

Under the new Taiwan regulations, manufacturers will be required to provide technical documentation on the network architecture of the medical software, the nature and quality of data input and collection, cybersecurity measures employed and the risks of use, among other information.