The government will help more companies speed up the marketing of digital medical devices developed by new technology throughout the entire process of commercialization by linking permission to new medical tech assessments.
The National Evidence-based Healthcare Collaborating Agency (NECA) and the Ministry of Food and Drug Safety (MFDS) said Thursday that the two agencies are reviewing and selecting products targeted for swift commercialization with a high possibility of applying for assessment as new medical technology.
Following three medical devices selected for pilot projects last year, the two agencies will support two additional items, including digital treatment devices.
For instance, the two agencies listed products used in neutron irradiation therapy for cancer and instruments that display the location of the lesion with augmented reality (AR) technology as innovative medical devices in May last year. Last month, they selected two more digital treatment devices for insomnia based on cognitive behavioral therapy and for teeth grinding with electromyography (EMG) signal.
The step-by-step supports include:
- Providing advice on designing clinical trials that link permits and new tech assessments.
- Giving data on the development situations of medical technology related to specific products.
- Offering advice on devices’ purpose of use to fit its indications.
- Advising on manufacturing and quality control according to good manufacturing practices (GMP).
“We expect that small and medium-sized enterprises, experiencing difficulties due to limitations in information and manpower despite having excellent technologies, will be able to enter the market quickly with our support for product approval and evaluation for new medical technologies,” the two agencies said.