Chinese Taipei: Technical guidelines for AI and ML based medical device software registration
Progress
Current status
adopted
11 Sep 2020 adopted
Scope
Implementers
Chinese Taipei
Policy Area
Design and testing standards
Policy Instrument
Design and testing standards, nes
Regulated Economic Activity
ML and AI development
software provider: other software
Government Branch
executive
Government Body
other regulatory body
Implementation Level
national
Timeline of events
Food and Drug Administration adopted technical guidelines for AI and ML based medical device software registration
On 11 September 2020, the Food and Drug Administration published the technical guidelines for Artificial Intelligence (AI)/Machine Learning (ML)-based medical device software registration. The guidelines apply to medical device software that uses cl…
Event type
outline
Action type
adoption
Government branch
executive
Government body
other regulatory body