AI-Based System Accelerates 'Medical Device Approval' Process

[Asia Economy Reporter Jo In-kyung] From now on, consultations on medical device approval using artificial intelligence (AI) chatbots will be conducted on a regular basis, and related data searches will become faster.

The Ministry of Food and Drug Safety announced on the 20th that it plans to introduce a next-generation medical device approval system enhanced with AI technology to process medical device approvals more quickly and accurately.

Starting next month, the ministry will begin analyzing medical device approval tasks and designing the system. After system implementation and trial operation by the end of the year, the next-generation medical device approval system is expected to be applied to actual work as early as 2023.

First, by introducing an AI chatbot, necessary information can be easily, quickly, and anytime accessed. Previously, applicants had to inquire during the working hours of the Ministry of Food and Drug Safety's medical device approval consultation staff, but with the AI chatbot, regardless of time, product developers can conveniently check whether a product qualifies as a medical device, the processing department for approval and review applications, and medical device users can check safety information.

By implementing AI-based data search functions, searches and confirmations related to approval and review materials will become faster and more accurate. Applying the 'machine learning technique,' which uses computer algorithms to analyze data and enables machines to learn autonomously to improve information processing capabilities, repetitive data search and confirmation tasks will be automated, allowing review officers to process approval and review tasks quickly and accurately.

The Ministry of Food and Drug Safety stated, "We will continue to enhance accessibility and efficiency in handling medical device approvals by applying the latest digital technologies based on regulatory science expertise and will make continuous efforts to ensure the safety management of medical devices."