CMDE Platform for AI Medical Device in China held its second management committee meeting this year online on September 21, 2022.
China’s Artificial Intelligent Medical Device Innovative and Collaborative Platform (hereinafter AIMDICP) was established on July 17, 2019. The AIMDICP operates under the guidance of the National Medical Products Administration (NMPA) and is affiliated with the Center for Medical Device Evaluation (CMDE). The main purpose of the platform is to encourage innovation and accelerate the application of artificial intelligence technology in the field of medical devices in China.
12 committee member representatives first carried out a closed-door meeting in the morning, followed by 17 working groups presenting status updates on each of their projects in the third quarter of 2022 as well as their upcoming plans in the next quarter.
Closed-door management committee meeting
During the closed-door meeting, the AIMDICP committee members approved the application of Institute of Biomedical Engineering (IBME) as a new joining member, and also approved IBME’s application to form a new working group focusing on the technology research and application of bio-digital therapy in China. IBME is the earliest research institute in China specializing in biomedical engineering and has successfully developed a vast amount of medical devices urgently needed for clinical use. IBME is also involved in drafting international standards as well as China’s national and industry standards.
In addition, the AIMDICP committee members approved the application of the CMDE to form a new working group focusing on digital therapy.
Further discussions were carried out in the closed-door meeting to approve the revision of the AIMDICP rules and regulations for internal operation procedures, as well as some important research projects as listed below:
- Project to setup a cervical cytology image database to meet the data quality and labeling standards and include 500 samples for supporting AI clinical diagnosis and treatment of cervical diseases.
- Project to develop methods for vulnerability assessment on AI medical devices covering research on applicability, network environment, scanning range, etc.
- 4 sets of technical requirements and testing methods for:
- 5G-based ultrasound diagnostic system
- 5G-based robotic diagnostic and treatment system
- 5G-based remote laparoscopic surgery assisting robot
- 5G-based telemedicine private network
Highlights of the AIMDICP 2022 third quarter report
- The cybersecurity working group carried out security tests on a DNA sequencing device during the third quarter, and the next step will be product evaluation to avoid losses caused by any identified vulnerability risks before issuing the certificate and completing the project.
- The clinical evaluation working group participated in the preparation of the China Medical Imaging AI Development Report 2021-2022 where they shared information about the clinical evaluation of deep learning medical devices. During the third quarter, they completed several clinical reviews of AI-assisted decision making products and carried out plans to prepare the clinical evaluation guidelines as a next step.
- The real-world data application working group focused on testing the diabetic retinopathy image database with several AI products, and developing a multimodal image database for age-related macular degeneration and pathologic myopia.
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