61% of This Year's Designated Innovative Medical Devices Are Software

The Ministry of Food and Drug Safety announced on the 4th that, as of last month, it has designated 13 products, including digital therapeutics utilizing digital health technology, as innovative medical devices.

Innovative medical devices are medical devices that apply advanced technologies with high technology intensity and rapid innovation speed, such as information and communication technology, biotechnology, and robotics, or improve usage methods, significantly enhancing or expected to enhance safety and efficacy compared to existing medical devices or treatments.

Among the 13 innovative medical devices, 8 products (approximately 61%) were 'medical device software.' This was followed by 4 products (31%) in 'instruments and apparatus' and 1 product (8%) in 'in vitro diagnostic medical devices.'

The Ministry of Food and Drug Safety supports the rapid commercialization of products designated as innovative medical devices by applying special approval procedures such as priority review when they are preparing for approval, including confirmatory clinical trials. In addition, to enable various products beyond medical device software, such as electronic drugs, to be designated as innovative medical devices, the ministry is providing proactive, customized support this year to 10 medical device development companies through the 'Innovative Medical Device Safety Management Full-Cycle Technical Support' project. Electronic drugs are products that treat mental, immune, and metabolic diseases by applying energy such as electrical stimulation to the human body.

The number of products designated as innovative medical devices has been increasing annually. Since the system was implemented in May 2020, a total of 165 products have applied for designation as innovative medical devices up to July this year, with 40 products designated, recording a designation rate of about 24%. This year, 13 out of 35 applied products were designated, showing a designation rate of 37%.

Among the 40 products designated as innovative medical devices so far, 9 have received 'special approval.' The Ministry of Food and Drug Safety plans to support the rapid commercialization of products by granting priority review and other approval exceptions when 15 products eligible for 'special approval' apply for medical device approval.

This content was produced with the assistance of AI translation services.