Taiwan’s Guidance on Registration of Artificial Intelligent / Machine Learning-Based Software as a Medical Device (AI/ML-Based SaMD)

The Taiwan Food and Drug Administration has released a guideline pertaining to the application of artificial intelligence related to medical devices which are aimed at medical device manufacturers.

This guidance is intended to be a useful resource on the registration of AI/ML-Based SaMD, to propose a regulatory framework for medical device manufacturers to register their products.

The Agency has formulated the guideline with the aim to ensure the performance, safety, and quality of medical device software through the utilization of artificial intelligence/machine learning technology.

The regulations of the United States, Japan, South Korea, and other countries and the International Medical Device Regulatory Forum (IMDRF) was referred by the Agency to provide Reference for the evaluation of the products developed by the manufacturer site and the information that is needed during inspection and registration. The relevant regulations of the Pharmaceutical Affairs Law should be abided by the learning medical device software.

The guideline contains information about the product description, safety, and performance verification parts based on the current reference materials. Nevertheless, the regulatory is not up to date considering the rapid development of science and technology.  The reviewers should take artificial intelligence into consideration during the application of inspection and registration in order to ensure the health and safety of patients
Product  features in artificial intelligence require manufacturers to provide safety and effectiveness verification and evaluation data other than those listed in this guideline
For more information, please refer to 人工智慧/機器學習技術之醫療器材軟體查驗登記技術指引 https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=26382


Share on Linkedin Send to Email

Questions? Request more information from our specialists!

Contact Us

More News