Medical device software accounted for 61 percent of all designated innovative medical devices through last month.
The Ministry of Food and Drug Safety said it is exploring ways for innovative medical devices to enjoy advantages in public tenders.
The ministry said Friday that it has designated 13 products as innovative medical devices through July this year, including digital treatment devices utilizing digital health technologies, such as big data, artificial intelligence (AI), wearables, mobile apps, and virtual reality (VR).
Innovative medical devices have significantly improved or are expected to improve safety and efficacy compared to existing medical devices or therapies by applying advanced technologies or improving usage methods in fields with high technology intensity and high innovation speed, including information and communication technology, biotechnology, and robotics.
Of the 13 innovative medical devices, there were eight software products, accounting for about 61 percent, followed by four apparatus and machinery (31 percent) and one in vitro diagnostic medical device (8 percent). This year's newly designated medical device software included left ventricular dysfunction electrocardiogram analysis and mild cognitive dysfunction improvement software.
The number of products designated as innovative medical devices has been increasing every year. Since the system was launched in May 2020, 40 products have been designated until last month. A total of 165 products applied for the designation, recording a designation rate of about 24 percent.
Of the 40 innovative medical devices, 12 were approved before designation, nine were granted exemptions from approval, and 15 were eligible for similar exemptions. After the designation, four products were approved without applying for special approval. The ministry supports special approval procedures, such as priority review for innovative medical devices.
The ministry said it is exploring ways to provide benefits (incentives) for innovative medical devices so that they could be included in the system of the Public Procurement Service. Products designated as innovative medical devices can enter the market smoothly after approval, based on inter-ministerial cooperation.
Besides, the ministry provided preemptive customized support to 10 medical device developers this year under the “Innovative Medical Device Safety Management Full Cycle Technical Support” project so that various products, including electronic drugs other than medical device software, can be designated as innovative medical devices.
These included electric stimulators to improve depressive symptoms, ultrasound surgical devices that deliver anticancer drugs, and in vitro diagnostic medical devices that provide information on gene mutations of rare diseases.
"The government plans to continue to expand the designation of innovative medical devices and improve the system to increase the effectiveness of special approval support and to enact the Digital Medical Product Act to embrace the innovation of advanced digital technologies and support the active development of innovative medical devices," the ministry said.