NYCU and GLORIA Host Medical Device Regulations Workshops, Highly Well-Received by Experts

2021-12-03

As part of the Industry–Academia Liaison Serial Events of Bio-navigator, in April 2021, the National Yang Ming Chiao Tung University Center of Entrepreneurship and Incubation, Global Research & Industry Alliance (GLORIA), and IRB co-organized the Workshop on Medical Equipment Regulations. The Workshop was attended by Dr. Teng Shin (an expert and international industry–academy liaison from the National Yang Ming Chiao Tung University), Wu Po-li (team leader of the Medical Equipment Department, Center for Drug Evaluation, Taiwan), Chou Yu-hsin (project manager), and Hsiao Chin-fu (researcher from Institute of Population Health Sciences, National Health Research Institutes) to discuss medical equipment regulations, clinical trial application procedures, trial designs, and GCP verification procedures. Workshop attendees praised the professionalism of the speakers and practicality of the content, expressing their wish to attend another workshop soon.

During his speech, Tsai Jin-wu, Dean of Research and Development, National Yang Ming Chiao Tung University, emphasized that the continuing development of AI medical equipment and software in the professional industry, universities, research sector, and medical services has increased the criticality of approving and obtaining legal certification. Through the analysis of legal experts who attended the workshop, Tsai wished to enhance the participants’ understanding of AI medical equipment & software regulations, and also key considerations in clinical trials.

Details on Medical Equipment Regulations and Website Resources

Since AI medical equipment and software are innovative products, during their design and development, it is necessary to communicate with relevant regulatory agencies about related legal requirements prior to the commercial launch of the products. However, the numerous law articles that have been formulated has increased the difficulty to accurately and effectively communicate with regulatory agencies. Accordingly, Dr. Teng shared relevant procedures and introduced website databases for academic and research units to determine whether their products are subject to certain medical equipment regulations; the risk classification of their medical equipment; details of similar products for related and comparative judgments; whether clinical trial data must be provided during inspection and registration; adopted standards; and test standards, among others. The goal was to allow academic and research teams to familiarize themselves with the document assessment criteria demanded by regulatory agencies prior to initial consultation, thereby improving the communication efficiency between the two parties.

Link: https://enews.nycu.edu.tw/w/nycuenews003/focus_21051115112287663

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