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[ NYCU News ] NYCU has obtained the license of medical equipment manufacturer and seller, which will inject new momentum into the commercialization of medical equipment

Yang Ming Jiaotong University is the first to obtain a medical device manufacturer and vendor license

"With the support of President Chih-Hung Lin, the Center for Innovative Medical Material Translation and Research (CIMR) has compiled and applied for two licenses for medical device vendors and manufacturers (medical software and implants) in August and September of this year respectively, which will give new impetus to the commercialization of medical devices.

According to the new system of the Medical Device Control Act, research institutions can apply for design-based medical device manufacturing and sales licenses with the consent of the competent authorities. This measure will greatly help to improve the quality, value, and technology of medical devices developed by research institutions, as well as to maximize the economic benefits of the National Science Council's grant program. Therefore, the University actively applied for the new system as soon as it was launched, and was successfully granted the two permits.

Professor Lin Junli, Director of the Center for Innovative Medical Material Translation and Research, said that the successful development of medical devices is not simply the application of engineering technology to biomedicine, but must meet the premise of "clinical needs", integration of regulatory testing / preclinical testing (or clinical testing), the establishment of industrial QMS and other stages of work, before further testing and registration for certification, and then can enter the "clinical implementation" The next step is to enter into "clinical implementation" and other applications. Therefore, the role of the Center for Innovative Medical Material Translation and Research (CIMR) in our university is to "promote the linkage of biomedical engineering," "integrate health and medical resources," "develop medical material industry clusters," and "promote innovative research and development axes" as the main axes, and to fully develop Med-Tech as the goal, injecting huge research and development translation energy for the development of medical devices in Taiwan.

The "Center for Innovative Medical Material Translation and Research" team is composed of five main research and development areas: precision medical implants, high-value biomedical materials, precision diagnostics and smart assistive devices, precision medical imaging and biomedical sensing care.
The acquisition of medical device vendor and manufacturer licenses not only helps the university's R&D team shorten the time to market for medical materials, but also strengthens the development of smart medical materials after the university's merger. Take medical software development as an example, after the pre-clinical testing and validation of the software, the QMS system can be certified; after passing the TFDA inspection by the Ministry of Health and Welfare, the manufacturing and inspection can be registered.

By obtaining the medical device manufacturer's license and sales license (certification numbers MD6101000739 and MD6201041374), the university will soon apply for medical device quality management system (QMS) certification by the Center for Innovative Medical Material Translation and Research and the university's medical software R&D team. The Center will apply for medical software registration with the TFDA of the Ministry of Health and Welfare.

In addition, the Center for Innovative Medical Material Translation and Research has obtained a medical device manufacturing and sales license, and has applied with the College of Biomedical Sciences and Engineering for the Ministry of Labor's Quality Management System Training Institute for Human Resource Development certification. In the future, our school will be able to undertake the certification course for medical material technician training of TFDA, in order to enhance the professional skills of practitioners and contribute to the development of medical material industry in Taiwan.
Medical device vendors (from left to right), manufacturer's licenses, and the Ministry of Labor's Human Resources Development and Quality Management System Training Institute Certification