– Promotion of next-generation medical device licensing system based on artificial intelligence (AI) –

 

□ The Ministry of Food and Drug Safety promotes advancement into the next-generation medical device licensing system based on artificial intelligence (AI) so that medical device licensing can be processed faster and more accurately.

ㅇ This upgrade of the licensing system was initiated to improve the quality and work efficiency of medical device licensing services.
– As early as 2023, the next-generation medical device licensing system incorporating artificial intelligence (AI) technology is expected to be applied to actual work.
* Establishment plan: Medical device licensing work analysis and system design ('22.6-August) → System implementation and test operation ('8-December) → Operation ('22.9-)

□ The main features of the AI-based next-generation licensing system are: ➊Anytime and quick Q&A using artificial intelligence chatbot, ➋Artificial intelligence-based licensing-related data search function.
➊ By introducing an artificial intelligence chatbot, you will be able to quickly and easily check the information you need at any time.
– By using the artificial intelligence chatbot, product developers can conveniently check whether a product is a medical device, the department that handles product licensing/examination applications, etc., and medical device users can conveniently check safety information.
➋ By implementing the AI-based licensing data search function, you can quickly and accurately check the licensing/examination related data.
– If this is used, machine learning* techniques are applied to automate repetitive data search and verification tasks, so that the person in charge of permitting and reviewing can process permitting and reviewing tasks quickly and accurately.
* Analyzing data using computer algorithms and improving information processing capabilities by allowing machines to learn on their own through data analysis

□ MFDS will continue to strive to improve the accessibility and efficiency of business processing such as licensing and licensing of medical devices by applying the latest digital technology based on its expertise in regulatory science, and to continuously strive for safety management of medical devices.

 

☞ Source: Korea Policy Briefing (2022.05.20.)