In a move to push forward the construction of Unique Device Identification (UDI) System and improve the management of classification of medical devices, CAMDI held the Training Session of Unique Device Identification and Classification of Medical Devices in Xi'an during November 23 to 24, 2018.
The Session was chaired by Yang Xiaofang, Deputy Secretary-General of CAMDI. Relevant leaders from the Department of Medical Device Registration and National Institutes for Food and Drug Control of China Food and Drug Administration (CFDA) attended the session and lectured on relevant matters. Yang pointed out at the opening of the session that both UDI and medical device classification represent hot fields in the current medical industry. Since experts has prepared this training session for a long time, all member units are required to make full use of this opportunity to learn something that can be put into practical use.
Yi Li, an expert from National Institutes for Food and Drug Control of CFDA, interpreted the progress of technology research on UDI system and the formulation of relevant standard. He also gave a detailed lecture on the concept, technical research, development in foreign countries, domestic demand and formulation of relevant standard of UDI, laying the foundation for the implementation of medical device UDI in China.
Huang Lunliang, an expert from the Department of Medical Device Registration of CFDA, interpreted the construction plan and rulemaking of UDI system. He detailed the origin, development and future direction of UDI in China based on the history and general idea of UDI in China. He also expressed his sincere wish for cooperation with peers in the industry in the hope of developing UDI in a better manner.
In his lecture on Problems Regarding the Implementation of Classified Catalogue Policy, Huang also introduced the revision of the Classified Catalogue and how it is implemented and explained problems regarding its implementation as well as practical method to such problems.
Yu Xinhua, director of the National Institutes for Food and Drug Control of CFDA, gave a lecture on the Rules for the Classification and dynamic adjustment of Classified Catalogue. He explained the post–market principles of classification management and special classification of medical devices and provided an deep insight into factors affecting the degree of risk for medical devices.
Rong Shankui, a doctor from the National Institutes for Food and Drug Control of CFDA, interpreted the introduction to the subdivisions of "Category of Medical Device Classification” – Ultrasound & Laser. He detailed the classification of ultrasonic surgical equipment and accessories, laser surgery equipment and accessories, high frequency/RF surgical equipment and accessories, microwave surgery equipment, cryosurgical equipment and accessories as well as shock wave surgery equipment. In addition, he analyzed and corrected problems that enterprises encountered in the classification of active medical devices.
During the training, representatives listened carefully to the lectures and asked questions actively, and the specialists patiently explained such questions.
In the end, Yang Xiaofang summarized the session and gave thanks to the support of the experts and representatives. CAMDI will continue to collect the needs and advise of its member units and carry out targeted high-quality training in an attempt to help enterprises solve practical problems and promote the development of the medical industry.
The Session was chaired by Yang Xiaofang, Deputy Secretary-General of CAMDI. Relevant leaders from the Department of Medical Device Registration and National Institutes for Food and Drug Control of China Food and Drug Administration (CFDA) attended the session and lectured on relevant matters. Yang pointed out at the opening of the session that both UDI and medical device classification represent hot fields in the current medical industry. Since experts has prepared this training session for a long time, all member units are required to make full use of this opportunity to learn something that can be put into practical use.
Yi Li, an expert from National Institutes for Food and Drug Control of CFDA, interpreted the progress of technology research on UDI system and the formulation of relevant standard. He also gave a detailed lecture on the concept, technical research, development in foreign countries, domestic demand and formulation of relevant standard of UDI, laying the foundation for the implementation of medical device UDI in China.
Huang Lunliang, an expert from the Department of Medical Device Registration of CFDA, interpreted the construction plan and rulemaking of UDI system. He detailed the origin, development and future direction of UDI in China based on the history and general idea of UDI in China. He also expressed his sincere wish for cooperation with peers in the industry in the hope of developing UDI in a better manner.
In his lecture on Problems Regarding the Implementation of Classified Catalogue Policy, Huang also introduced the revision of the Classified Catalogue and how it is implemented and explained problems regarding its implementation as well as practical method to such problems.
Yu Xinhua, director of the National Institutes for Food and Drug Control of CFDA, gave a lecture on the Rules for the Classification and dynamic adjustment of Classified Catalogue. He explained the post–market principles of classification management and special classification of medical devices and provided an deep insight into factors affecting the degree of risk for medical devices.
Rong Shankui, a doctor from the National Institutes for Food and Drug Control of CFDA, interpreted the introduction to the subdivisions of "Category of Medical Device Classification” – Ultrasound & Laser. He detailed the classification of ultrasonic surgical equipment and accessories, laser surgery equipment and accessories, high frequency/RF surgical equipment and accessories, microwave surgery equipment, cryosurgical equipment and accessories as well as shock wave surgery equipment. In addition, he analyzed and corrected problems that enterprises encountered in the classification of active medical devices.
During the training, representatives listened carefully to the lectures and asked questions actively, and the specialists patiently explained such questions.
In the end, Yang Xiaofang summarized the session and gave thanks to the support of the experts and representatives. CAMDI will continue to collect the needs and advise of its member units and carry out targeted high-quality training in an attempt to help enterprises solve practical problems and promote the development of the medical industry.