In order to further improve the registration application efficiency of medical devices, enhance product quality and service standards, and add new impetus into the high-quality regional development of the industry, the Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection of NMPA (GBACDEI) hosted the “Thematic Training on Clinical Evaluation and Inspection of the Medical Devices in the Greater Bay Area” in Hengqin, Zhuhai on May 24, 2024. Professor Hu Hao of the Institute of Chinese Medical Sciences (ICMS) and the Centre for Pharmaceutical Regulatory Sciences, University of Macau (CPRS) led a group of researchers to participate in this training.

This training focused on multilevel topics of clinical evaluation and inspection of medical devices. Liu Bin, Director of the GBACDEI, introduced the establishment and measures for innovative development of the center, and clearly pointed out the importance of promoting regulatory science to provide a more convenient and scientific path to achieve a higher level of regulatory control and to ensure the safety and efficacy of medical devices. Zhang Yidan and Lu Minqi, speakers from the GBACDEI, introduced the registration pathways, as well as the registration dossier and review requirements for the clinical evaluation of medical devices respectively. Teng Yingying, a speaker from the Center for Medical Device Evaluation of NPRA, discussed about issues related to real-world research design and statistical analysis of medical devices, and explored the application of real-world data in clinical evaluation of medical devices. In addition, Lu Shuchao, a speaker from the Center for Food and Drug Inspection of NMPA, and Li Xiaomeng, a speaker from the National Center for Cardiovascular Diseases, conducted detailed explanations on the supervision and inspections of the clinical trial of medical devices, the requirements of “Good clinical practice for medical devices” and the basic concepts and control requirements of data management in clinical trial of medical devices. Through this training, the CPRS team gained an in-depth understanding of the entire process of clinical evaluation of medical devices, as well as product review and evaluation requirements, which will help ​inform the subsequent research about the full product lifecycle management of medical devices.

This training was guided by the Center for Medical Device Evaluation and the Center for Food and Drug Inspection of NMPA, and was supported by the Zhuhai Municipal Administration for Market Regulation. This training was also co-organized by the Guangdong Food and Drug Technology Association for Evaluation and Certification, the Commercial Services Bureau of Guangdong-Macao In-Depth Cooperation Zone in Hengqin and the Traditional Chinese Medicine Science and Technology Industrial Park of Co-operation between Guangdong and Macao.

Professor Hu Hao of ICMS and CPRS led a group of researchers to participate in the training

On the spot