Yang-Ming GLORIA 【The Bio-Navigator Lecture Series】 National Yang Ming Chiao Tung University Medical Device Regulation Workshop: Professional Attendees Going Home with Fruitful Results


The Center for Industry-Academia Collaboration, and Global Research & Industry Alliance (GLORIA) of National Yang Ming Chiao Tung University (NYCU) have co-organized the Medical Device Regulation Workshop with the Institutional Review Board as part of the 2021 Bio-Navigator Lecture series. Dr. Shin Teng, GLORIA liaison expert, Yang Ming Campus, Team Leader Po-Li Wu and Project Manager  Yu-Hsin Chou of Division of Medical Devices, Center for Drug Evaluation, and Investigator Chin-Fu Hsiao, Institute of Population Health Sciences of the National Health Research Institutes, have shared with the audience their experiences of medical device regulations and clinical trial application process, experimental design, and GCP audit. The workshop ended successfully on the 23rd of April at the auditorium of the Yang Ming Campus. The attendees were in heated discussions and benefited a great deal from the workshop. They looked forward to the professional sharing again as they found the lecturers professional and the lecture content helpful.


NYCU President for Research & Development Jin-Wu Tsai (fourth from the right) presented the certificates of appreciation, and had a group photo taken with Chief Executive Officer Hsien-Chih Pei of the Center for Industry-Academia Collaboration and GLORIA, Yang Ming Campus (second from the right,) Chief Operating Officer Hung-Yu Lin of GLORIA, Yang Ming Campus (first on the right), and the lecturer


NYCU President for Research & Development Jin-Wu Tsai emphasized in his welcome speech that the industry, academic, research, and medical field professionals are devoting themselves to developing artificial intelligence (AI) medical device software. Passing the registration process is hence a topic of concern for them. Hopefully, the regulatory experts' analyses presented in the workshop would make scholars understand the critical considerations in regulatory management and clinical trials regarding AI medical software.


NYCU President for Research & Development Jin-Wu Tsai addressed the audience.


Introduction to Medical Device Regulations and Online Databases

Given the innovativeness of AI technology-based medical device software, frequent communication with the regulatory authority regarding the regulatory requirements for product launch during the product design and development period is necessary. However, most academic and research units face numerous regulations and laws and need to understand how to communicate to and discuss with the regulatory authority precisely and efficiently. In this workshop, Dr. Shin Teng shared her thinking steps and the public online databases. She has also provided the academic and research units with information on how to determine the medical device regulations regulate their developed products or not, medical device risk classification, and how similar products are classified. She has also shared information on whether it is necessary to provide clinical trial reports, recognized standards, and announce testing standards, and so on during registration. It is hoped that after the workshop, academic and research teams understand the regulatory authorities' requirements for the evaluation of the documents to be consulted in advance before the consultation to improve the communication efficiency between the two parties.


Introduction to the Regulations on the AI-based Medical Devices

People from all walks of life are concerned about whether all health and medical care-related software will be subject to regulation? Not all medical software is regulated as a medical device. Dr. Shin Teng explained how the Taiwan Food and Drug Administration (TFDA) defines and manages "medical software" and "medical device software" using the "Guidance for the Classification of Medical Software" announced by the TFDA. In the end, Dr. Shin Teng introduced the US FDA regulations for launching medical devices and also sorted out the appropriate uses of AI-medical devices approved by the US FDA in recent years. Dr. Teng has also introduced to the audience three classic cases of AI-medical device software approved in 2018, OsteoDetect, ContaCT, and IDX-DR, including their approved indications and analyses of the submitted launch materials. In addition to the aforementioned classic AI products launched through a De Novo application, Dr. Teng has also introduced the brain tumor auto-contouring product Vbrain, which was launched this April through the 510(k) pathway. This medical device saves physicians the time to manually map the contours of a brain (artificial artificial intelligence) while performing radiotherapy treatment. By analyzing the above successful product launches, we hope to help the academic and research teams better understand the regulatory requirements before product launch registration. 


Dr. Shin Teng introduced the regulations for medical device product launch and

the classic cases of AI-medical device software in the U.S.


Clinical Trial Application Process and Sharing of Practical Experience

We have invited Project Manager  Yu-Hsin Chou of Division of Medical Devices, Center for Drug Evaluation, to the first session of the workshop in the afternoon to explain the application process and document preparation for TFDA medical device clinical trial application. Clinical trial applications can be divided into academic research-based and registration-based depending on the trial's purpose. Manager Chou has illustrated the differences in the required documents and application procedures between these two types of applications. With the " Medical Device Act " being implemented soon, Manager Chou has also summarized its relevant regulations and provisions regarding clinical trial management. TFDA has announced "Clinical Trials for Non-Significant Risk Medical Devices (Draft)" this February. In connection to this notice, Manager Chou has explained that applicants may be exempted from applying for the central competent authority's approval if their future clinical trials comply with the statement.


Project Manager Yu-Hsin Chou introduced the application process and document preparation

for medical device clinical trial application.


Clinical Trial Design for AI-based Medical Device Software

The effectiveness of AI-based medical device software needs to be verified through frequent clinical trials. Team Leader/Doctor Po-Li Wu of Division of Medical Devices, Center for Drug Evaluation, shared his considerations regarding the regulations for AI-based medical device software clinical trial design during clinical trial review and counseling. While designing a clinical trial for a product, emphasized Team Leader Wu, the purpose of the product should be taken into consideration. This factor will affect the collection of trial parameters and the selection of evaluation indicators and remind the designers that the trial design should conform to or be applied to real-life scenarios.


InvestigatorPo-Li Wu shared his considerations regarding the regulations

for AI-medical device software clinical trial design.


Execution of Medical Device Clinical Trial GCP Audits

After completing clinical trials for inspection and registration, the TFDA will perform GCP audits to confirm the quality and authenticity of the trial data. Investigator Chin-Fu Hsiao, Institute of Population Health Sciences of the National Health Research Institutes, delivered the grand finale speech in the afternoon. He shared his many years of experience in audit while serving as a TFDA medical device clinical trial GCP statistics committee member. Investigator Hsiao introduced the regulatory requirements for the medical device GCP statistical items and also each of the audit items of the statistics section. He then listed some of the statistics flaws in the audit and shared his experience, allowing the scholars in the workshop to understand the GCP regulatory requirements better.


Investigator Chin-Fu Hsiao shared his experience
in the audit of the medical device GCP statistics section.


A significant number of people attended the workshop, which was met with enthusiastic responses. The scholars showed initiative in discussing and interacting with the lecturers during the break, showing their need to know medical device regulations. The attending experts stated afterward that this workshop on medical device regulations was handy and down to earth, and they benefited a lot from it.


The attending experts raised questions about clinical trials (left). The attending experts and scholars were in a heated discussion with the lecturer during the break (right)