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Advancing Regulatory System of Artificial Intelligent Medical Device

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2021-11-16
  • Last Updated:2021-11-16

Information and communications technology (ICT) and the medical industries are two pillars holding up Taiwan’s industry sector.  In order to support the development of our industries, Taiwan Food and Drug Administration (TFDA) implements the “Medical Device Act” on May 1st, 2021 to not only speed up the review process for commercializing the new medical device that meets the medical needs, but also encourage the research and development of domestic products.

TFDA announced several digital health related guidelines, including the field of AI/ML, software as medical devices, cybersecurity, and intelligent technology medical devices.  The “Guidance on the qualification and classification of software as medical device” was revised on Dec. 24th, 2020 for better understanding the difference between Medical Software and Medical Device Software.  In addition, due to technology flourishing on the IoT, wireless network and the cloud platform, the “Guidance on Medical Device Cybersecurity Applicable to Manufacturers” was updated on May 3rd, 2021.  Moreover, the “Guideline for Artificial Intelligent / Machine Learning-Based Software as a Medical Device Registration” was announced on Sep. 11th, 2021.  Since there are more and more computer-assisted detection or triage medical device software, the “Technical Guidance on Registration and Market Approval of AI/ML-Based CADe SaMD” was published on July 7th, 2021 accordingly.

Globalization brings industries and competent authorities ever closer together, TFDA is willing to consistently share our experiences and expertise through activities and other ventures from an international perspective.  Through the understanding and learning processes among peers, we can remain up-to-date in the global medical device field and promote products that offer better health.