12th China International Medical Device Regulatory Forum held in Wuhan

Sponsored by the China Center for Food and Drug International Exchange (CCFDIE), the 12th China International Medical Device Regulatory Forum opened on Sept 24 in Wuhan, capital of Central China's Hubei province. Hubei Deputy Governor Zhang Wenbing delivered a welcome speech. Xu Jinghe, deputy commissioner of the National Medical Products Administration (NMPA), attended and spoke at the opening ceremony.

Xu said that since its establishment in 2018 the NMPA has conscientiously implemented the Four Most Stringent Requirements, adhered to the mission of protecting and promoting public health and been committed to a scientific, law-based, international and modern development path. It has continued to deepen the reform of the medical device review and approval system, strengthen full lifecycle quality supervision of medical devices, promote scientific research in medical device supervision, enhance building of regulatory capabilities and expand international exchanges and cooperation in medical devices, so as to accelerate China's development by leaps and bounds from a big medical device manufacturer to a power in medical devices.

He noted that medical device management should uphold the principles of openness and mutual benefits to facilitate coordination of international regulatory rules, persevere in reform and innovation to promote industrial innovative development, drive scientific growth to propel progress in regulatory science, and maintain full-process supervision to prevent and control safety risks. In an era of globalization and informatization, efforts should be made to protect and promote public health, accelerate scientific development of medical devices, jointly build a global community of health for all, adhere to a scientific, law-based, international and modern development path, and make new and greater contributions to human health and well-being.

Paying close attention to medical device supervision and the anti-COVID-19 fight, the conference was themed on implementing the newly revised Regulations for Supervision and Administration of Medical Devices and promoting new developments in regulatory science.

Officials from the NMPA's Department of Medical Device Registration, Department of Medical Device Regulation, Department of Science, Technology and International Cooperation, the Center for Medical Device Evaluation, and the Center for Medical Device Standards Management comprehensively analyzed China's medical device regulatory laws and regulations, and introduced in detail the reform of China's medical device review and approval system, standard management, traceability system construction, industrial development and international cooperation.

The conference was also attended by representatives of medical device watchdogs, fellows from related associations and professionals from the US, Japan, Saudi Arabia and other countries and regions. Participants shared online or offline the latest progress in medical device supervision in accordance with relevant laws and regulations in their countries and regions. They also discussed how to respond to the challenges in medical devices in the global anti-virus fight.

In addition to the plenary meeting, the conference also focused on hot issues in the medical device industry at 17 sub-forums on such topics as medical device innovation, medical device clinical evaluation, medical device regulatory science, medical device product R&D and human factor design and usability. Experts and scholars in the medical device industry at home and abroad exchanged views on the latest issues and cutting-edge technologies of medical devices under the new situation.

Two parallel meetings were held at the same time, which played a role in promoting medical device supervision. A meeting on medical device management gathered leaders from some of the world's most innovative and influential medical device enterprises, investment institutions and regulatory departments to explore new opportunities for industrial development. The other meeting, on legal affair talent development, discussed new methods of talent growth with relevant training institutions, institutions of higher education and regulatory departments.