[의학신문·일간보사=정민준 기자]The Ministry of Food and Drug Safety has developed evaluation criteria for artificial intelligence medical device software as diagnostic aids for dementia, prostate cancer, and colon cancer.
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On the 23rd, the Ministry of Food and Drug Safety (Director Kang-rip Kim) developed evaluation criteria such as safety and performance, and produced it as a guide for rapid commercialization of three types of artificial intelligence (AI) medical device software with such contents.
The three kinds of artificial intelligence (AI) medical device software are brain image detection and diagnosis aid software, prostate cancer image detection and diagnosis aid software, and colon cancer image detection and diagnosis aid software.
The main contents of the guide are △Artificial Intelligence (AI) software safety and performance evaluation criteria, △medical device cybersecurity application method, △clinical trial design method and effectiveness evaluation criteria.
The evaluation criteria developed this time have been technicalized by forming a consultative body with a developer so that the optimum criteria for safety and performance evaluation can be followed from the development stage of the product. As part of the’Korean New Deal Comprehensive Plan’, through medical big data. It was promoted to support the development of the’Doctor Answers’ program by the Ministry of Science and Technology Information and Communication, an artificial intelligence (AI) service that supports doctors’ treatment and diagnosis.
Dr.Answer (Ai, network, software, er) is composed of diagnostic support software for 8 serious diseases such as dementia and was developed with an investment of 36.4 billion won from 2018 to 2020.
The Ministry of Food and Drug Safety expects that, according to the development of the evaluation criteria, future developers will be able to increase efficiency in procedures such as product development strategy preparation, clinical trial planning, and approval.
The Ministry of Food and Drug Safety was selected as the first chairman of the artificial intelligence medical device working group at this year’s’International Medical Device Regulatory Forum (IMDRF)’. Leading the standard.
The’International Medical Device Regulatory Forum (IMDRF)’ is a council of regulatory authorities in 10 countries, including the United States and Europe, leading the international regulatory harmonization of medical devices, and Korea joined in December 2017.
In addition, the Ministry of Food and Drug Safety has produced a video that introduces the targets and main contents of the 10 AI medical device guidelines published so far.
An official from the Ministry of Food and Drug Safety said, “In order to expand patient treatment opportunities through research and development of advanced medical devices, we will preemptively provide evaluation criteria for advanced medical devices and actively support the product development of the’Dr. said.
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▼Artificial Intelligence Medical Device Permit/Certification Status |
Reporter Jeong Min-joon [email protected]
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