The Ministry of Food and Drug Safety said it would expand the scope of artificial intelligence-based medical devices from 11 to 153 items, and ease regulations on approving medical equipment.
The ministry on Friday announced that it would revise the guidelines for AI-based medical device approval review and expand the scope of the devices.
The latest move is part of the government’s “Task for Regulatory Innovation in New Industries.” The food and drug safety ministry aimed to solve medical device makers’ problems caused by regulations and to help them speed up the commercialization of advanced medical devices.
By revising the guidelines for the review on medical device approval, the government increased the scope of medical devices from 11 items to 153, including universal ultrasound image diagnosis device and X-ray.
“The seven items benefitting from the latest change were included in the top 20 export items in 2018. The manufacturers of these items will have a shorter time for product development, which will also enhance the competitiveness of the local medical device industry,” the ministry said in a statement.
The government will also provide information for designing clinical trials of AI-based medical devices and “Frequently Asked Questions (FAQ)” for each stage of product development, with explanations on four major diseases -- lung cancer/pulmonary nodule, breast cancer, ischemic stroke (cerebral infarction), and coronary stenosis.
The main contents of the four disease guidelines include an example design of the retrospective clinical study, the criteria for selection/exclusion of subjects by disease, and efficacy evaluation variables.
The ministry will provide answers to FAQs by AI-based medical device makers such as product approval, stages for follow-up management, and support programs for companies in product development.
The details are available on the food and drug safety ministry’s homepage at www.mfds.go.kr.